Obesity, Weight Loss, Diabetes Mellitus
Conditions
Brief summary
A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg \[LIRA 3mg\] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.
Detailed description
Summary of Trial Design A two year, parallel, two group, open-label, real-world, RCT design for patients with severe and complex obesity who are referred to a Tier 3 obesity service (including patients who are referred to a Tier 3 service as part of the bariatric surgery pathway). The total duration of participation will be 104 weeks (+/-2 weeks). The first 52 weeks of the study (after randomisation) will determine whether using the targeted prescribing pathway in a Tier 3 setting will result in more participants attaining ≥15% weight loss compared with standard care. The second 52 weeks of the study will assess whether patients who lose ≥15% of their baseline weight by the first 52 weeks are more likely to maintain ≥15% weight loss for another 52 weeks in the targeted prescribing pathway compared with standard care. Further, budget impact, cost-effectiveness, improvement in obesity-related co-morbidities, complementary aspects of safety, effectiveness, adherence, and treatment satisfaction of both treatment groups will be assessed and compared. Participants will be randomised in a 2:1 fashion to either the intervention (targeted prescribing pathway + standard care) or control (standard care) group (2 intervention: 1 control). The control group will receive standard care in a specialist obesity service (Tier 3 or equivalent), according to the best practice in each site and can include total or partial meal replacement strategies. The intervention group will receive the same standard care as the control group (i.e. according to the best practice in each site) plus all participants will initially receive LIRA with pre-specified stopping rules. The targeted prescribing pathway: participants who do not meet the definition of a 'early and good responder' (defined as achieving ≥5% weight loss at 16 weeks, ≥10% weight loss at 32 weeks and ≥15% weight loss at 52 weeks) will have their LIRA 3mg treatment stopped. It is important to note that all participants will be analysed in the group to which they are randomised; in particular, participants in the intervention group who stop receiving LIRA 3mg will remain in the intervention group and will continue to receive standard care for the remainder of the study as per the targeted prescribing pathway (albeit, the part of the pathway where LIRA 3mg is not prescribed; see Figure 1). The study is intentionally designed to reflect a pragmatic real-world scenario and each Tier 3 provider may require a different number of visits for their programme. However, study appointments for data collection, titration reviews, application of the stopping rules of LIRA 3mg, and dispensing will be standardised for all of the five sites. Intervention (Targeted Prescribing Pathway) The NHS Weight Management pathway is divided into four distinct tiers: Tier 1: health promotion Tier 2: lifestyle interventions Tier 3: specialist multidisciplinary weight management services Tier 4: bariatric surgery Across the UK, each region has a specialist Tier 3 obesity and/or weight management service or equivalent, usually referred to as Tier 3. This includes a clinician led multidisciplinary team approach, potentially including a specialist physician, nurse, dietician, psychologist, physiotherapist, etc. From this point forwards, Tier 3 specialist weight management and/or equivalent services will be referred to as 'Tier 3' throughout the remainder of this protocol. Participants in the intervention group will receive the same standard care as those in the control group, i.e. the best medical practice delivered by the Tier 3 service at each site. Additionally, at baseline, LIRA 3mg will be prescribed to all of the participants in the intervention group at a starting dose of 0.6mg daily. Dose escalation of Liraglutide will occur according to a pre-specified titration protocol, from 0.6mg to a maximum of 3.0mg daily. Liraglutide dose will be initiated at 0.6mg and then increased to 1.2mg in Week 2, 1.8mg in Week 3, 2.4mg in Week 4, and 3.0mg in Week 5. Participants in the intervention group will be aware that the LIRA 3mg treatment may be stopped at various time points throughout the duration of the study and that continued use of LIRA 3mg is based upon their response to the treatment in terms of them achieving pre-defined weight loss targets at 16, 32 and 52 weeks.. Specifically, participants in the intervention group will continue to be prescribed LIRA 3mg for the 104 week duration of the study, unless one of the following stopping rules applies: 1. st stopping rule: After 16 weeks (± 14 days) on the medication, only those participants who have lost ≥5% of their baseline weight will be offered further treatment with LIRA 3mg for another 16 weeks. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study. 2. nd stopping rule: After 32 weeks (± 14 days) on the medication, only those participants who have lost ≥10% of their baseline weight and are still on treatment with LIRA 3mg will be offered another 20 weeks on LIRA 3mg. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study. 3. rd stopping rule: After the first year of treatment (week 52; ± 14 days), only those participants who have lost ≥15% of their baseline weight and are still on treatment with LIRA 3mg will be offered another 52 weeks on LIRA 3mg. Participants who have not met this weight loss target will have their LIRA 3mg treatment stopped but will still continue in the targeted prescribing pathway but will receive standard care only during the remainder of the study. Participants who fail to reach the pre-defined weight-loss targets to continue LIRA 3mg treatment, or who choose to stop receiving LIRA 3mg, will continue to be offered the standard care provided by the Tier 3 service. These participants will still attend the Clinical Review Visits but not the additional visits for participants who are still on LIRA 3mg (e.g. Weeks 65 & 91) because these visits will not be relevant to them; visits at Weeks 65 and 91 are intended to provide a new prescription of LIRA 3mg and to discuss adherence and any side effects;; see Appendices 2 & 3). Participants will remain routinely in the Tier 3 service in-line with NICE guidance throughout the duration of the research study. Participants may be offered treatment options within the duration of the study, including bariatric surgery, as per NICE guidance and according to the decision of the local Tier 3 Multidisciplinary Team. Participants who have undergone bariatric surgery after randomisation will only be included in the intention to treat (ITT) analysis. This decision was made because the proportion of participants undergoing bariatric surgery is likely to be unbalanced between the treatment groups (i.e. more participants in the control group are expected to have bariatric surgery than in the targeted prescribing pathway treatment group), and thus weight loss in these individuals could unduly influence the study results. Participants who have been prescribed and start anti-obesity medication (such as Orlistat) will be ineligible for LIRA 3mg treatment. Control (Standard Care) Participants in the control group will follow the best medical care provided by the Tier 3 service at the relevant site. This typically involves dietary advice to reduce energy intake (and may include a period of partial or total meal replacement), accompanied - if available - by a physical activity programme, both supported by behavioural change techniques with regular professional contacts. The nature of the standard care will vary between the different Tier 3 services at each site, as this is a pragmatic 'real-world' study. Clinician input will include the medical assessment of participants for severe and complicated obesity and the prescription of anti-obesity drugs (such as Orlistat) as per local Tier 3 service policy. As with the LIRA 3mg group those patients taking antihypertensive or antidepressant medication will be assessed and it will be at the clinician's discretion as to whether these medications are changed. Participants will remain routinely in the Tier 3 service in-line with NICE guidance throughout the duration of the research study. Participants may be offered treatment options within the duration of the study, including bariatric surgery, as per NICE guidance and according to the decision of the local Tier 3 Multidisciplinary Team.
Interventions
DRUGSaxenda
standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose)
OTHERSpecialist Obesity Management Services
Specialist Obesity Management Services standard of care
Sponsors
Novo Nordisk A/S
University of Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* be aged between 18-75 years old (inclusive) * understand written and spoken English * be able to give in informed consent * a body mass index ≥35 kg/m2, * have been referred to Tier 3 weight management or equivalent service in one of the five participating sites, * have a stable body weight (less than 5kg self-reported change during the previous 12 weeks), * Participant must be able to meet at least one of the inclusion criteria listed below: 1. prediabetes (defined as established diagnosis of impaired fasting glycaemia (IFG) from GP and/or established diagnosis of impaired glucose tolerance (IGT) from GP and/or HbA1C 42-47 mmol/mol (6-6.4%) without glucose lowering medications, at a blood test during the last 6 months) and/or 2. type 2 diabetes \[defined as established diagnosis of Type II diabetes from GP and/or HbA1C ≥48 mmol/mol (\>6.5%) at a blood test during the last 6 months\] being treated with any combination of lifestyle, metformin, sulphonylureas, thiazolidinediones (TZDs) or SGLT-2, and/or 3. hypertension treated (defined as being on antihypertensive treatment with or without a diagnosis of hypertension from GP) or untreated (defined as Systolic Blood Pressure (SBP) ≥140 mmHg at two consecutive visits at the Tier 3 clinic), and/or 4. obstructive sleep apnoea (on CPAP or established diagnosis of Apnoea Hypopnoea Index ≥15 at sleep studies during the last 12 months)
Exclusion criteria
* Diagnosis of Type 1 diabetes * Type 2 diabetes with treatment on DPP-IV or insulin currently * Treatment with GLP-1 receptor agonists within the last 6 months and/or have a history of GLP-1 receptor agonist intolerance. * Treatment with anti-obesity drugs within the last 12 weeks prior to randomisation * eGFR ≤30ml/min/1.73m2 on serum testing over the last 26 weeks * Females referred to the clinic because of fertility problem * Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods during the study period * Have terminal illness * Are not primarily responsible for their own care * Not willing or able to give informed consent * Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant's ability to participate * Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid- stimulating hormone \>6 mIU/liter or \<0.4 mIU/liter * Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) * Personal history of non-familial medullary thyroid carcinoma * History of chronic pancreatitis or idiopathic acute pancreatitis * Amylase levels three times higher than the upper normal range * Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome) * Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium) * History of major depressive episode during the last 2 years * History of initiation of antidepressants during the last 12 weeks * Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. * Previous surgical treatment for obesity (excluding liposuction if performed \>1 year before trial entry) * History of other severe psychiatric disorders * History of known or suspected abuse of alcohol and/or narcotics * History of major depressive episode during the last 2 years * Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss of ≥15% From Baseline (Complete Cases) | 52 weeks | Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service. |
| Weight Loss of ≥15% From Baseline (Intention to Treat) | 52 weeks | Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service. |
| Weight Loss of ≥15% From Baseline (Per Protocol) | 52 weeks | Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service. |
| Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications) | 52 weeks | Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | 52 weeks | Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 16 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 16 weeks. |
| Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | 52 weeks | Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 32 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 32 weeks. |
| Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | 52 weeks | Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 52 weeks. |
| Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | 104 weeks | Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 104 weeks. |
| Referral to Other Obesity Interventions (Intention to Treat) | 104 weeks | Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period |
| Referral to Other Obesity Interventions by Site (Intention to Treat) | 104 weeks | Referrals for bariatric surgery by 104 weeks, stratified by study site. |
| Bariatric Surgery Completion (Intention to Treat) | 104 weeks | Number of participants who underwent bariatric surgery by 104 weeks. |
| Weight Loss of ≥5% From Baseline (Complete Cases) | 16 weeks | Proportion of participants reaching weight loss of ≥5% from baseline, at 16 weeks. |
| Weight Loss of ≥10% From Baseline (Complete Cases) | 16 weeks | Proportion of participants reaching weight loss of ≥10% from baseline, at 16 weeks. |
| Weight Loss of ≥15% From Baseline (Complete Cases) | 16 weeks | Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks. |
| Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases) | 104 weeks | Proportion of participants maintaining weight loss of ≥15% among those who lost ≥15% at 52 weeks |
| Absolute Weight Change (Complete Cases) | 16 weeks | Absolute change in weight (kg) from baseline |
| Percentage Weight Change (Complete Cases) | 16 weeks | Percentage change in weight from baseline |
| Absolute BMI Change (Complete Cases) | 52 weeks | Absolute change in BMI (kg/m2) from baseline |
| Absolute Waist Circumference Change (Complete Cases) | 52 weeks | Absolute change in waist circumference (cm) from baseline |
| Participant Attendance at Appointments (Intention to Treat) | 52 weeks | Attended at least 70% of scheduled Tier 3 appointments by 52 weeks |
| Patient Health Questionnaire-9 (Complete Cases) | 52 weeks | Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes. |
| Epworth Sleepiness Scale (Complete Cases) | 52 weeks | Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome. |
| Stop Bang Questionnaire (Complete Cases) | 52 weeks | Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome. |
| Glycaemic Status (Complete Cases) | 52 weeks | Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status. |
| HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | 52 weeks | Proportion of participants HbA1c ≤7% at 52 weeks, among those with diabetes at baseline. |
| HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | 52 weeks | Proportion of participants HbA1c ≤6.5% at 52 weeks, among those with diabetes at baseline. |
| Hypertension (Complete Cases) | 52 weeks | Proportion of participants with hypertension at 52 weeks. |
| Weight Loss of ≥5% From Baseline (Responder Population) | 16 weeks | Proportion of participants reaching weight loss of ≥5% from baseline at 16 weeks. |
| Weight Loss of ≥10% From Baseline (Responder Population) | 16 weeks | Proportion of participants reaching weight loss of ≥10% from baseline at 16 weeks. |
| Weight Loss of ≥15% From Baseline (Responder Population) | 16 weeks | Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks. |
| Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population) | 104 weeks | Proportion of participants who maintained weight loss of ≥15% among those who lost ≥15% at 52 weeks. |
| Percentage Weight Change (Responder Population) | 16 weeks | Percentage change in weight from baseline |
| Absolute BMI Change (Responder Population) | 52 weeks | Absolute change in BMI (kg/m2) from baseline |
| Absolute Waist Circumference Change (Responder Population) | 52 weeks | Absolute change in waist circumference (cm) from baseline |
| Kings College Obesity Staging (KCOS) Score (Complete Cases) | 52 weeks | Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes. |
| Cessation of Treatment Due to Adverse Effects (Intention to Treat) | 52 weeks | Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 52 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response. |
| Participant Compliance With Treatment (Intention to Treat) | 52 weeks | Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 52 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study. |
| Patient Stopping of Treatment (Intention to Treat) | 16 weeks | Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 16 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point. |
Countries
Ireland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care | 260 |
| Standard Care Arm Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care | 132 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Tolerance | 5 | 0 |
| Overall Study | Unknown/no reason given | 50 | 39 |
Baseline characteristics
| Characteristic | Total | Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Standard Care Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 32 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 341 Participants | 228 Participants | 113 Participants |
| Age, Continuous | 51.34 years STANDARD_DEVIATION 10.79 | 51.10 years STANDARD_DEVIATION 10.81 | 51.81 years STANDARD_DEVIATION 10.77 |
| Average total MET | 5318.24 Minutes/week STANDARD_DEVIATION 7412.94 | 5246.83 Minutes/week STANDARD_DEVIATION 7145.63 | 5463.48 Minutes/week STANDARD_DEVIATION 7958.59 |
| BMI | 45.99 Kg/m2 STANDARD_DEVIATION 7.58 | 46.22 Kg/m2 STANDARD_DEVIATION 7.75 | 45.52 Kg/m2 STANDARD_DEVIATION 7.25 |
| Diastolic Blood Pressure | 81.57 mmHg STANDARD_DEVIATION 11.31 | 81.35 mmHg STANDARD_DEVIATION 10.94 | 81.99 mmHg STANDARD_DEVIATION 12.04 |
| Glycaemic Status Diabetes | 139 Participants | 98 Participants | 41 Participants |
| Glycaemic Status Diabetes remission | 12 Participants | 9 Participants | 3 Participants |
| Glycaemic Status Missing | 3 Participants | 1 Participants | 2 Participants |
| Glycaemic Status Normogylcaemia | 176 Participants | 110 Participants | 66 Participants |
| Glycaemic Status Prediabetes | 62 Participants | 42 Participants | 20 Participants |
| HbA1c % | 6.32 % STANDARD_DEVIATION 1.18 | 6.36 % STANDARD_DEVIATION 1.27 | 6.24 % STANDARD_DEVIATION 0.99 |
| HbA1c mmol/mol | 45.64 Mmol/mol STANDARD_DEVIATION 12.82 | 46.10 Mmol/mol STANDARD_DEVIATION 13.72 | 44.71 Mmol/mol STANDARD_DEVIATION 10.79 |
| HDL Cholesterol | 1.24 mmol/L STANDARD_DEVIATION 0.4 | 1.24 mmol/L STANDARD_DEVIATION 0.3 | 1.25 mmol/L STANDARD_DEVIATION 0.55 |
| Heart Rate | 78.30 Beats/minute STANDARD_DEVIATION 11.55 | 78.27 Beats/minute STANDARD_DEVIATION 11.21 | 78.37 Beats/minute STANDARD_DEVIATION 12.24 |
| Hypertension Status Missing | 2 Participants | 2 Participants | 0 Participants |
| Hypertension Status No | 140 Participants | 96 Participants | 44 Participants |
| Hypertension Status Yes | 250 Participants | 162 Participants | 88 Participants |
| LDL Cholesterol | 2.71 mmol/L STANDARD_DEVIATION 0.84 | 2.71 mmol/L STANDARD_DEVIATION 0.84 | 2.70 mmol/L STANDARD_DEVIATION 0.83 |
| Number of all Medications Five and over | 166 Participants | 108 Participants | 58 Participants |
| Number of all Medications Four | 31 Participants | 24 Participants | 7 Participants |
| Number of all Medications None | 85 Participants | 55 Participants | 30 Participants |
| Number of all Medications One | 35 Participants | 24 Participants | 11 Participants |
| Number of all Medications Three | 41 Participants | 32 Participants | 9 Participants |
| Number of all Medications Two | 34 Participants | 17 Participants | 17 Participants |
| Number of Antihypertensive Medications Does not have hypertension | 142 Participants | 98 Participants | 44 Participants |
| Number of Antihypertensive Medications None | 68 Participants | 44 Participants | 24 Participants |
| Number of Antihypertensive Medications One | 80 Participants | 55 Participants | 25 Participants |
| Number of Antihypertensive Medications Three and over | 47 Participants | 30 Participants | 17 Participants |
| Number of Antihypertensive Medications Two | 55 Participants | 33 Participants | 22 Participants |
| Number of Diabetes Medications Does not have diabetes | 253 Participants | 162 Participants | 91 Participants |
| Number of Diabetes Medications None | 47 Participants | 35 Participants | 12 Participants |
| Number of Diabetes Medications One | 74 Participants | 52 Participants | 22 Participants |
| Number of Diabetes Medications Three and over | 3 Participants | 2 Participants | 1 Participants |
| Number of Diabetes Medications Two | 15 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 24 Participants | 13 Participants | 11 Participants |
| Race/Ethnicity, Customized Mixed/Other | 15 Participants | 11 Participants | 4 Participants |
| Race/Ethnicity, Customized South Asian | 14 Participants | 11 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 339 Participants | 225 Participants | 114 Participants |
| Sex: Female, Male Female | 252 Participants | 173 Participants | 79 Participants |
| Sex: Female, Male Male | 140 Participants | 87 Participants | 53 Participants |
| Sleep Apnoea Status Missing | 33 Participants | 23 Participants | 10 Participants |
| Sleep Apnoea Status No | 167 Participants | 113 Participants | 54 Participants |
| Sleep Apnoea Status Yes | 192 Participants | 124 Participants | 68 Participants |
| Smoking status Current smoker | 38 Participants | 25 Participants | 13 Participants |
| Smoking status Ex-smoker | 138 Participants | 90 Participants | 48 Participants |
| Smoking status Missing | 1 Participants | 1 Participants | 0 Participants |
| Smoking status Never smoker | 215 Participants | 144 Participants | 71 Participants |
| Statin Use No | 291 Participants | 190 Participants | 101 Participants |
| Statin Use Yes | 101 Participants | 70 Participants | 31 Participants |
| Systolic Blood Pressure | 136.56 mmHg STANDARD_DEVIATION 18.12 | 135.77 mmHg STANDARD_DEVIATION 18.26 | 138.12 mmHg STANDARD_DEVIATION 17.79 |
| Total Cholesterol | 4.75 mmol/L STANDARD_DEVIATION 0.98 | 4.76 mmol/L STANDARD_DEVIATION 1 | 4.74 mmol/L STANDARD_DEVIATION 0.95 |
| Triglycerides | 1.85 mmol/L STANDARD_DEVIATION 0.94 | 1.85 mmol/L STANDARD_DEVIATION 0.94 | 1.86 mmol/L STANDARD_DEVIATION 0.94 |
| Waist Circumference | 132.23 Centimetre STANDARD_DEVIATION 14.73 | 132.44 Centimetre STANDARD_DEVIATION 15.56 | 131.81 Centimetre STANDARD_DEVIATION 12.95 |
| Weight | 128.37 Kg STANDARD_DEVIATION 24.08 | 129.02 Kg STANDARD_DEVIATION 25.33 | 127.09 Kg STANDARD_DEVIATION 21.42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 260 | 0 / 132 |
| other Total, other adverse events | 238 / 260 | 89 / 132 |
| serious Total, serious adverse events | 43 / 260 | 16 / 132 |
Outcome results
Primary
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Time frame: 52 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Complete Cases) | 51 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Complete Cases) | 6 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [2.09, 12.88]Regression, Logistic
Primary
Weight Loss of ≥15% From Baseline (Intention to Treat)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Intention to Treat) | 55 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Intention to Treat) | 6 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [2.45, 14.4]Regression, Logistic
Primary
Weight Loss of ≥15% From Baseline (Per Protocol)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Time frame: 52 weeks
Population: Per protocol population All participants who were compliant with their randomised treatment, analysed according to the treatment group to which they were randomised. Standard care group are compliant if they complete \>70% of the planned contacts in the T3 service. The intervention group are compliant if they complete \>70% of the planned contacts in the T3 service, and take \>70% of their prescribed LIRA 3mg. Excludes participants who had bariatric surgery during the study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Per Protocol) | 40 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Per Protocol) | 5 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.00295% CI: [1.81, 14.01]Regression, Logistic
Primary
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Time frame: 52 weeks
Population: Per protocol population. All participants who were compliant with their randomised treatment, analysed according to the treatment group to which they were randomised. Standard care group are compliant if they complete \>70% of the planned contacts in the T3 service. The intervention group are compliant if they complete \>70% of the planned contacts in the T3 service, and take \>70% of their prescribed LIRA 3mg. Excludes participants who had bariatric surgery during the study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications) | 40 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications) | 5 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.00295% CI: [1.88, 14.64]Regression, Logistic
Secondary
Absolute BMI Change (Complete Cases)
Absolute change in BMI (kg/m2) from baseline
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute BMI Change (Complete Cases) | -2.30 kg/m2 | Standard Deviation 3.29 |
| Standard Care Arm | Absolute BMI Change (Complete Cases) | -0.49 kg/m2 | Standard Deviation 3.57 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-2.91, -0.86]Regression, Linear
Secondary
Absolute BMI Change (Complete Cases)
Absolute change in BMI (kg/m2) from baseline
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute BMI Change (Complete Cases) | -3.84 kg/m2 | Standard Deviation 3.29 |
| Standard Care Arm | Absolute BMI Change (Complete Cases) | -1.17 kg/m2 | Standard Deviation 2.84 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-3.5, -1.91]Regression, Linear
Secondary
Absolute BMI Change (Responder Population)
Absolute change in BMI (kg/m2) from baseline
Time frame: 104 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute BMI Change (Responder Population) | -4.86 kg/m2 | Standard Deviation 2.91 |
| Standard Care Arm | Absolute BMI Change (Responder Population) | -0.49 kg/m2 | Standard Deviation 3.57 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-5.56, -2.89]Regression, Linear
Secondary
Absolute BMI Change (Responder Population)
Absolute change in BMI (kg/m2) from baseline
Time frame: 52 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute BMI Change (Responder Population) | -7.65 kg/m2 | Standard Deviation 1.65 |
| Standard Care Arm | Absolute BMI Change (Responder Population) | -1.17 kg/m2 | Standard Deviation 2.84 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-7.03, -5.28]Regression, Linear
Secondary
Absolute Waist Circumference Change (Complete Cases)
Absolute change in waist circumference (cm) from baseline
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Waist Circumference Change (Complete Cases) | -8.88 Centimetres | Standard Deviation 7.89 |
| Standard Care Arm | Absolute Waist Circumference Change (Complete Cases) | -5.58 Centimetres | Standard Deviation 8.48 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.0195% CI: [-5.77, -0.8]Regression, Linear
Secondary
Absolute Waist Circumference Change (Complete Cases)
Absolute change in waist circumference (cm) from baseline
Time frame: 104 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Waist Circumference Change (Complete Cases) | -6.42 Centimetres | Standard Deviation 8.44 |
| Standard Care Arm | Absolute Waist Circumference Change (Complete Cases) | -0.93 Centimetres | Standard Deviation 12.54 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.00395% CI: [-9.09, -1.94]Regression, Linear
Secondary
Absolute Waist Circumference Change (Responder Population)
Absolute change in waist circumference (cm) from baseline
Time frame: 52 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Waist Circumference Change (Responder Population) | -15.33 Centimetres | Standard Deviation 6.02 |
| Standard Care Arm | Absolute Waist Circumference Change (Responder Population) | -5.58 Centimetres | Standard Deviation 8.48 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-11.96, -5.64]Regression, Linear
Secondary
Absolute Waist Circumference Change (Responder Population)
Absolute change in waist circumference (cm) from baseline
Time frame: 104 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Waist Circumference Change (Responder Population) | -10.20 Centimetres | Standard Deviation 8.42 |
| Standard Care Arm | Absolute Waist Circumference Change (Responder Population) | -0.93 Centimetres | Standard Deviation 12.54 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.00195% CI: [-14.91, -4.27]Regression, Linear
Secondary
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Time frame: 16 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Weight Change (Complete Cases) | -9.61 kg | Standard Deviation 5.38 |
| Standard Care Arm | Absolute Weight Change (Complete Cases) | -5.54 kg | Standard Deviation 5.87 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-5.85, -3.4]Regression, Linear
Secondary
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Weight Change (Complete Cases) | -10.15 kg | Standard Deviation 9.45 |
| Standard Care Arm | Absolute Weight Change (Complete Cases) | -3.21 kg | Standard Deviation 8.66 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-9.03, -4.71]Regression, Linear
Secondary
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Time frame: 32 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Weight Change (Complete Cases) | -11.27 kg | Standard Deviation 7.7 |
| Standard Care Arm | Absolute Weight Change (Complete Cases) | -5.70 kg | Standard Deviation 7.16 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-7.76, -4.02]Regression, Linear
Secondary
Absolute Weight Change (Complete Cases)
Absolute change in weight (kg) from baseline
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Absolute Weight Change (Complete Cases) | -6.51 kg | Standard Deviation 9.28 |
| Standard Care Arm | Absolute Weight Change (Complete Cases) | -1.27 kg | Standard Deviation 10.3 |
Comparison: A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-8.34, -2.53]Regression, Linear
Secondary
Bariatric Surgery Completion (Intention to Treat)
Number of participants who underwent bariatric surgery by 104 weeks.
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Bariatric Surgery Completion (Intention to Treat) | No | 142 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Bariatric Surgery Completion (Intention to Treat) | Yes | 6 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Bariatric Surgery Completion (Intention to Treat) | Missing | 112 Participants |
| Standard Care Arm | Bariatric Surgery Completion (Intention to Treat) | No | 64 Participants |
| Standard Care Arm | Bariatric Surgery Completion (Intention to Treat) | Yes | 4 Participants |
| Standard Care Arm | Bariatric Surgery Completion (Intention to Treat) | Missing | 64 Participants |
Secondary
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 104 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | No | 53 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Yes | 2 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | N/A | 205 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Missing | 0 Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Missing | NA Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | N/A | NA Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Yes | NA Participants |
Secondary
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 52 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | No | 111 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Missing | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Yes | 3 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | N/A | 146 Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | N/A | NA Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Yes | NA Participants |
| Standard Care Arm | Cessation of Treatment Due to Adverse Effects (Intention to Treat) | Missing | NA Participants |
Secondary
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 16 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 16 weeks.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | No | 60 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | Yes | 19 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | N/A (still using Liraglutide 3mg at 16 weeks) | 181 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | Missing | 0 Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | Missing | NA Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | N/A (still using Liraglutide 3mg at 16 weeks) | NA Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat) | Yes | NA Participants |
Secondary
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 32 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 32 weeks.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who stopped liraglutide 3mg treatment at 32 weeks.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | No | 49 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | Yes | 22 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | N/A (still using Liraglutide 3mg at 32 weeks) | 110 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | Missing | 0 Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | Missing | NA Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | N/A (still using Liraglutide 3mg at 32 weeks) | NA Participants |
| Standard Care Arm | Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat) | Yes | NA Participants |
Secondary
Epworth Sleepiness Scale (Complete Cases)
Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome.
Time frame: 104 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at baseline | 85 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at follow-up | 90 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at baseline | 25 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 20 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 11 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at baseline | 38 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at baseline | 17 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at follow-up | 44 Participants |
Secondary
Epworth Sleepiness Scale (Complete Cases)
Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome.
Time frame: 52 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at baseline | 111 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at follow-up | 119 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at baseline | 34 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 26 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 12 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at baseline | 47 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | Possible obstructive sleep apnoea at baseline | 15 Participants |
| Standard Care Arm | Epworth Sleepiness Scale (Complete Cases) | No obstructive sleep apnoea at follow-up | 50 Participants |
Secondary
Glycaemic Status (Complete Cases)
Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.
Time frame: 104 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Normoglycaemia at baseline | 25 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Normoglycaemia at follow-up | 31 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Prediabetes at baseline | 13 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Prediabetes at follow-up | 8 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes remission at baseline | 5 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes remission at follow-up | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes at baseline | 58 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes at follow-up | 62 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes at follow-up | 22 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Normoglycaemia at baseline | 19 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes remission at baseline | 1 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Normoglycaemia at follow-up | 15 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes at baseline | 19 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Prediabetes at baseline | 7 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes remission at follow-up | 1 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Prediabetes at follow-up | 8 Participants |
Secondary
Glycaemic Status (Complete Cases)
Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.
Time frame: 52 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Normoglycaemia at baseline | 52 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Normoglycaemia at follow-up | 67 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Prediabetes at baseline | 21 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Prediabetes at follow-up | 10 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes remission at baseline | 8 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes remission at follow-up | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes at baseline | 84 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Glycaemic Status (Complete Cases) | Diabetes at follow-up | 88 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes at follow-up | 23 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Normoglycaemia at baseline | 24 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes remission at baseline | 2 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Normoglycaemia at follow-up | 24 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes at baseline | 21 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Prediabetes at baseline | 9 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Diabetes remission at follow-up | 2 Participants |
| Standard Care Arm | Glycaemic Status (Complete Cases) | Prediabetes at follow-up | 7 Participants |
Secondary
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤6.5% at 52 weeks, among those with diabetes at baseline.
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | No | 17 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | Yes | 37 Participants |
| Standard Care Arm | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | No | 14 Participants |
| Standard Care Arm | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | Yes | 3 Participants |
Secondary
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤6.5% at 104 weeks, among those with diabetes at baseline.
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | No | 16 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | Yes | 23 Participants |
| Standard Care Arm | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | No | 12 Participants |
| Standard Care Arm | HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases) | Yes | 5 Participants |
Secondary
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤7% at 52 weeks, among those with diabetes at baseline.
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | No | 10 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | Yes | 44 Participants |
| Standard Care Arm | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | No | 11 Participants |
| Standard Care Arm | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | Yes | 6 Participants |
Secondary
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
Proportion of participants HbA1c ≤7% at 104 weeks, among those with diabetes at baseline.
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | No | 10 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | Yes | 29 Participants |
| Standard Care Arm | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | No | 10 Participants |
| Standard Care Arm | HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases) | Yes | 7 Participants |
Secondary
Hypertension (Complete Cases)
Proportion of participants with hypertension at 104 weeks.
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at baseline | No | 35 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at baseline | Yes | 92 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at follow-up | No | 38 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at follow-up | Yes | 89 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at follow-up | Yes | 43 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at baseline | No | 16 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at follow-up | No | 15 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at baseline | Yes | 42 Participants |
Secondary
Hypertension (Complete Cases)
Proportion of participants with hypertension at 52 weeks.
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at baseline | No | 37 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at baseline | Yes | 135 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at follow-up | No | 41 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Hypertension (Complete Cases) | Hypertension at follow-up | Yes | 131 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at follow-up | Yes | 59 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at baseline | No | 20 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at follow-up | No | 21 Participants |
| Standard Care Arm | Hypertension (Complete Cases) | Hypertension at baseline | Yes | 60 Participants |
Secondary
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.
Time frame: 52 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at baseline | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at follow-up | 1 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at baseline | 6 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at follow-up | 23 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at baseline | 97 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at follow-up | 108 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at baseline | 42 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at follow-up | 13 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at follow-up | 8 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at baseline | 0 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at baseline | 41 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at follow-up | 0 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at baseline | 17 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at baseline | 5 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at follow-up | 43 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at follow-up | 12 Participants |
Secondary
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.
Time frame: 104 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at baseline | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at follow-up | 2 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at baseline | 5 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at follow-up | 16 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at baseline | 84 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at follow-up | 86 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at baseline | 26 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at follow-up | 11 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at follow-up | 6 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at baseline | 0 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at baseline | 37 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Normal health at follow-up | 0 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Advanced disease at baseline | 10 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at baseline | 4 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | Established disease at follow-up | 35 Participants |
| Standard Care Arm | Kings College Obesity Staging (KCOS) Score (Complete Cases) | At risk of disease at follow-up | 10 Participants |
Secondary
Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)
Proportion of participants maintaining weight loss of ≥15% among those who lost ≥15% at 52 weeks
Time frame: 104 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases) | 12 Participants |
| Standard Care Arm | Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases) | 2 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.60195% CI: [0.08, 4.24]Regression, Logistic
Secondary
Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population)
Proportion of participants who maintained weight loss of ≥15% among those who lost ≥15% at 52 weeks.
Time frame: 104 weeks
Population: Complete cases. All individuals in both arms (intervention and control group) who have data available for the outcome being analysed (proportion of participants who maintained at 104 weeks weight loss of \>=15% among those who lost \>=15% weight loss at 52 weeks) according to the study group to which they were randomised. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population) | 12 Participants |
| Standard Care Arm | Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population) | 2 Participants |
Comparison: A logistic regression with a binary outcome of maintenance of weight loss of ≥15% at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.60195% CI: [0.08, 4.24]Regression, Logistic
Secondary
Participant Attendance at Appointments (Intention to Treat)
Attended at least 70% of scheduled Tier 3 appointments by 104 weeks
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | No | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | Yes | 92 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | Did not attend week 104 visit | 117 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | Attended week 104 visit but variable missing | 51 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | Attended week 104 visit but variable missing | 20 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | No | 0 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | Did not attend week 104 visit | 66 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | Yes | 46 Participants |
Secondary
Participant Attendance at Appointments (Intention to Treat)
Attended at least 70% of scheduled Tier 3 appointments by 52 weeks
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | No | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | Did not attend week 52 visit | 60 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | Yes | 115 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Attendance at Appointments (Intention to Treat) | Attended week 52 visit but variable missing | 85 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | Yes | 51 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | No | 1 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | Attended week 52 visit but variable missing | 37 Participants |
| Standard Care Arm | Participant Attendance at Appointments (Intention to Treat) | Did not attend week 52 visit | 43 Participants |
Secondary
Participant Compliance With Treatment (Intention to Treat)
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 104 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Compliance With Treatment (Intention to Treat) | No | 27 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Compliance With Treatment (Intention to Treat) | Yes | 229 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Compliance With Treatment (Intention to Treat) | Missing | 4 Participants |
| Standard Care Arm | Participant Compliance With Treatment (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Participant Compliance With Treatment (Intention to Treat) | Yes | NA Participants |
| Standard Care Arm | Participant Compliance With Treatment (Intention to Treat) | Missing | NA Participants |
Secondary
Participant Compliance With Treatment (Intention to Treat)
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 52 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Compliance With Treatment (Intention to Treat) | Missing | 4 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Compliance With Treatment (Intention to Treat) | No | 23 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Participant Compliance With Treatment (Intention to Treat) | Yes | 233 Participants |
| Standard Care Arm | Participant Compliance With Treatment (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Participant Compliance With Treatment (Intention to Treat) | Yes | NA Participants |
| Standard Care Arm | Participant Compliance With Treatment (Intention to Treat) | Missing | NA Participants |
Secondary
Patient Health Questionnaire-9 (Complete Cases)
Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.
Time frame: 52 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at baseline | 27 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at follow-up | 48 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at baseline | 33 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at follow-up | 30 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at baseline | 29 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at follow-up | 27 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at baseline | 32 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at follow-up | 18 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at baseline | 18 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at follow-up | 16 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at follow-up | 6 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at baseline | 16 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at follow-up | 14 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at follow-up | 24 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at follow-up | 10 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at baseline | 15 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at baseline | 2 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at follow-up | 9 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at baseline | 7 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at baseline | 23 Participants |
Secondary
Patient Health Questionnaire-9 (Complete Cases)
Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.
Time frame: 104 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at follow-up | 32 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at baseline | 20 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at baseline | 23 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at baseline | 19 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at follow-up | 12 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at baseline | 27 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at baseline | 13 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at follow-up | 21 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at follow-up | 11 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at follow-up | 26 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at follow-up | 3 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at follow-up | 10 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at baseline | 15 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Minimal depression at follow-up | 17 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at baseline | 10 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Mild depression at follow-up | 16 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at baseline | 3 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderately severe depression at follow-up | 4 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Severe depression at baseline | 4 Participants |
| Standard Care Arm | Patient Health Questionnaire-9 (Complete Cases) | Moderate depression at baseline | 18 Participants |
Secondary
Patient Stopping of Treatment (Intention to Treat)
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 16 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Time frame: 16 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | No | 181 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | Yes | 79 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | Missing | 0 Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | Yes | NA Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | Missing | NA Participants |
Secondary
Patient Stopping of Treatment (Intention to Treat)
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 52 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who were on liraglutide 3mg treatment at the previous time-point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | No | 53 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | Yes | 57 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | Missing | 0 Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | Yes | NA Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | Missing | NA Participants |
Secondary
Patient Stopping of Treatment (Intention to Treat)
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 32 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Time frame: 32 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who were on liraglutide 3mg treatment at the previous time-point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | No | 110 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | Yes | 71 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Patient Stopping of Treatment (Intention to Treat) | Missing | 0 Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | No | NA Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | Yes | NA Participants |
| Standard Care Arm | Patient Stopping of Treatment (Intention to Treat) | Missing | NA Participants |
Secondary
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Complete Cases) | -8.13 percentage | Standard Deviation 7.21 |
| Standard Care Arm | Percentage Weight Change (Complete Cases) | -2.67 percentage | Standard Deviation 6.79 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-7.02, -3.71]Regression, Linear
Secondary
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Time frame: 16 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Complete Cases) | -7.63 percentage | Standard Deviation 4.02 |
| Standard Care Arm | Percentage Weight Change (Complete Cases) | -4.39 percentage | Standard Deviation 4.45 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-4.63, -2.8]Regression, Linear
Secondary
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Time frame: 32 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Complete Cases) | -9.00 percentage | Standard Deviation 5.82 |
| Standard Care Arm | Percentage Weight Change (Complete Cases) | -4.58 percentage | Standard Deviation 5.74 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-6.14, -3.25]Regression, Linear
Secondary
Percentage Weight Change (Complete Cases)
Percentage change in weight from baseline
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Complete Cases) | -5.18 percentage | Standard Deviation 7.47 |
| Standard Care Arm | Percentage Weight Change (Complete Cases) | -1.21 percentage | Standard Deviation 8.16 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.00195% CI: [-6.42, -1.77]Regression, Linear
Secondary
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Time frame: 104 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Responder Population) | -11.01 percentage | Standard Deviation 6.7 |
| Standard Care Arm | Percentage Weight Change (Responder Population) | -1.21 percentage | Standard Deviation 8.16 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-12.35, -6.26]Regression, Linear
Secondary
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Time frame: 16 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Responder Population) | -11.45 percentage | Standard Deviation 3.62 |
| Standard Care Arm | Percentage Weight Change (Responder Population) | -4.39 percentage | Standard Deviation 4.45 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-7.81, -5.29]Regression, Linear
Secondary
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Time frame: 32 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Responder Population) | -14.82 percentage | Standard Deviation 3.85 |
| Standard Care Arm | Percentage Weight Change (Responder Population) | -4.58 percentage | Standard Deviation 5.74 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-11.3, -7.88]Regression, Linear
Secondary
Percentage Weight Change (Responder Population)
Percentage change in weight from baseline
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Percentage Weight Change (Responder Population) | -17.21 percentage | Standard Deviation 2.43 |
| Standard Care Arm | Percentage Weight Change (Responder Population) | -2.67 percentage | Standard Deviation 6.79 |
Comparison: A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [-15.51, -11.51]Regression, Linear
Secondary
Referral to Other Obesity Interventions by Site (Intention to Treat)
Referrals for bariatric surgery by 104 weeks, stratified by study site.
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions by Site (Intention to Treat) | Dublin | 3 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions by Site (Intention to Treat) | Glasgow | 0 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions by Site (Intention to Treat) | Leicester | 10 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions by Site (Intention to Treat) | Liverpool | 2 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions by Site (Intention to Treat) | London | 10 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions by Site (Intention to Treat) | Not referred / missing | 235 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions by Site (Intention to Treat) | London | 1 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions by Site (Intention to Treat) | Dublin | 3 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions by Site (Intention to Treat) | Liverpool | 1 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions by Site (Intention to Treat) | Glasgow | 0 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions by Site (Intention to Treat) | Not referred / missing | 127 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions by Site (Intention to Treat) | Leicester | 0 Participants |
Secondary
Referral to Other Obesity Interventions (Intention to Treat)
Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions (Intention to Treat) | No | 125 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions (Intention to Treat) | Yes | 25 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Referral to Other Obesity Interventions (Intention to Treat) | Missing | 110 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions (Intention to Treat) | No | 64 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions (Intention to Treat) | Yes | 5 Participants |
| Standard Care Arm | Referral to Other Obesity Interventions (Intention to Treat) | Missing | 63 Participants |
Secondary
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 104 weeks.
Time frame: 104 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | No | 144 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | Yes | 3 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | Missing | 113 Participants |
| Standard Care Arm | Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | No | 64 Participants |
| Standard Care Arm | Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | Yes | 2 Participants |
| Standard Care Arm | Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat) | Missing | 66 Participants |
Secondary
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 52 weeks.
Time frame: 52 weeks
Population: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | No | 203 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | Yes | 3 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | Missing | 54 Participants |
| Standard Care Arm | Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | No | 92 Participants |
| Standard Care Arm | Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | Yes | 1 Participants |
| Standard Care Arm | Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat) | Missing | 39 Participants |
Secondary
Stop Bang Questionnaire (Complete Cases)
Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome.
Time frame: 52 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at baseline | 10 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at follow-up | 18 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at baseline | 34 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 43 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at baseline | 49 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at follow-up | 32 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at baseline | 28 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at baseline | 4 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 14 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at follow-up | 10 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at follow-up | 20 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at baseline | 12 Participants |
Secondary
Stop Bang Questionnaire (Complete Cases)
Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome.
Time frame: 104 weeks
Population: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at baseline | 11 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at follow-up | 12 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at baseline | 26 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 38 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at baseline | 47 Participants |
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at follow-up | 34 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at baseline | 24 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at baseline | 3 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at follow-up | 13 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | No obstructive sleep apnoea at follow-up | 4 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Likely obstructive sleep apnoea at follow-up | 23 Participants |
| Standard Care Arm | Stop Bang Questionnaire (Complete Cases) | Possible obstructive sleep apnoea at baseline | 13 Participants |
Secondary
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 32 weeks.
Time frame: 32 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Complete Cases) | 110 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Complete Cases) | 14 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [3.32, 12.86]Regression, Logistic
Secondary
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 104 weeks.
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Complete Cases) | 32 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Complete Cases) | 8 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.06595% CI: [0.95, 5.47]Regression, Logistic
Secondary
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 52 weeks.
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Complete Cases) | 90 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Complete Cases) | 9 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [3.8, 17.16]Regression, Logistic
Secondary
Weight Loss of ≥10% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥10% from baseline, at 16 weeks.
Time frame: 16 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Complete Cases) | 60 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Complete Cases) | 9 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [2.14, 12.39]Regression, Logistic
Secondary
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 32 weeks.
Time frame: 32 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Responder Population) | 53 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Responder Population) | 14 Participants |
Secondary
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 104 weeks.
Time frame: 104 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Responder Population) | 23 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Responder Population) | 8 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [2.75, 21.6]Regression, Logistic
Secondary
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 16 weeks.
Time frame: 16 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Responder Population) | 34 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Responder Population) | 9 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [7.55, 70.67]Regression, Logistic
Secondary
Weight Loss of ≥10% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥10% from baseline at 52 weeks.
Time frame: 52 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥10% From Baseline (Responder Population) | 51 Participants |
| Standard Care Arm | Weight Loss of ≥10% From Baseline (Responder Population) | 9 Participants |
Secondary
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Complete Cases) | 15 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Complete Cases) | 2 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.0795% CI: [0.89, 18.93]Regression, Logistic
Secondary
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.
Time frame: 32 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Complete Cases) | 32 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Complete Cases) | 5 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥32% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.02395% CI: [1.17, 8.9]Regression, Logistic
Secondary
Weight Loss of ≥15% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.
Time frame: 16 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Complete Cases) | 10 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Complete Cases) | 2 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.20695% CI: [0.56, 14.34]Regression, Logistic
Secondary
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.
Time frame: 32 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Responder Population) | 24 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Responder Population) | 5 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [3.8, 34.67]Regression, Logistic
Secondary
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 52 weeks.
Time frame: 52 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Responder Population) | 51 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Responder Population) | 6 Participants |
Secondary
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.
Time frame: 104 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Responder Population) | 12 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Responder Population) | 2 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.00395% CI: [2.47, 75.09]Regression, Logistic
Secondary
Weight Loss of ≥15% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.
Time frame: 16 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥15% From Baseline (Responder Population) | 8 Participants |
| Standard Care Arm | Weight Loss of ≥15% From Baseline (Responder Population) | 2 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.03295% CI: [1.16, 32.32]Regression, Logistic
Secondary
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 52 weeks.
Time frame: 52 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Complete Cases) | 127 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Complete Cases) | 29 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [2.39, 7.22]Regression, Logistic
Secondary
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 32 weeks.
Time frame: 32 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Complete Cases) | 158 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Complete Cases) | 34 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [2.86, 9.36]Regression, Logistic
Secondary
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 16 weeks.
Time frame: 16 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Complete Cases) | 186 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Complete Cases) | 34 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [5.26, 19.48]Regression, Logistic
Secondary
Weight Loss of ≥5% From Baseline (Complete Cases)
Proportion of participants reaching weight loss of ≥5% from baseline, at 104 weeks.
Time frame: 104 weeks
Population: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Complete Cases) | 62 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Complete Cases) | 17 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: 0.0195% CI: [1.23, 4.84]Regression, Logistic
Secondary
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 16 weeks.
Time frame: 16 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Responder Population) | 54 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Responder Population) | 34 Participants |
Secondary
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 52 weeks.
Time frame: 52 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Responder Population) | 51 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Responder Population) | 29 Participants |
Secondary
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 32 weeks.
Time frame: 32 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Responder Population) | 53 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Responder Population) | 34 Participants |
Secondary
Weight Loss of ≥5% From Baseline (Responder Population)
Proportion of participants reaching weight loss of ≥5% from baseline at 104 weeks.
Time frame: 104 weeks
Population: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care) | Weight Loss of ≥5% From Baseline (Responder Population) | 33 Participants |
| Standard Care Arm | Weight Loss of ≥5% From Baseline (Responder Population) | 17 Participants |
Comparison: A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).p-value: <0.00195% CI: [3.83, 28.97]Regression, Logistic