Overweight, Obesity
Conditions
Brief summary
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people who are above a healthy weight range to lose weight. Semaglutide tablets are a new medicine being tested to treat people living with excess body weight. Participants will either get semaglutide or placebo once daily morning for 44 weeks. In addition to taking the medicine, participants will have talks with study staff about: * Healthy food choices * How to be more physically active * What participants can do to lose weight This study will last for about 1 year.
Interventions
DRUGSemaglutide
Participants will receive semaglutide tablets orally once daily for 44 weeks.
Participants will receive placebo matched to semaglutide.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female, age greater than or equal to 18 years at the time of signing informed consent. * Body mass index (BMI) of 1. greater than or equal to 28.0 kilogram per meter square (kg/m\^2) or 2. greater than or equal to 24.0 kg/m\^2 with greater than or equal to 1 weight-related comorbidity (treated or untreated). Weight-related comorbidities should be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. * History of at least one self-reported unsuccessful dietary effort to lose body weight. For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4: * Diagnosed with T2D greater than or equal to 180 days prior to screening. * Treated with either diet and exercise alone or stable treatment (same drug(s) or active ingredient, dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or glitazone). * HbA1c 7.0 - 10.0 percent (53 - 86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening.
Exclusion criteria
Participants without T2D at screening: * HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes. * Treatment with glucose-lowering agent(s) within 90 days prior to screening. Participants with T2D at screening: * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Renal impairment measured as estimated glomerular filtration rate (eGFR) value of lesser than 30 milli litre per min/1.73 square metre (mL/min/1.73 m\^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Change in Body Weight | From baseline (week 0) to end of treatment (week 44) | Measured in percentage (%) |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent | At end of treatment (week 44) | Measured as count of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent | At end of treatment (week 44) | Measured as count of participants |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent | At end of treatment (week 44) | Measured as count of participants |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain | From baseline (week 0) to end of treatment (week 44) | IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score. |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score | From baseline (week 0) to end of treatment (week 44) | IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score. |
| Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) - Total Score | From randomisation (week 0) to end-of-treatment (week 44) | IWDAQ is a 18-item obesity-specific PRO measure developed to evaluate daily activity limitations associated with excess weight. It uses an adaptive questionnaire design where the participant chooses the three IWDAQ activities they would most like to improve with weight loss and rate the degree of limitations in each of the three activities at baseline. The same three activities are assessed for degree of limitations at follow-up to allow for tracking of activities relevant to each individual. |
| Change in Body Mass Index (BMI) | From baseline (week 0) to end of treatment (week 44) | Measured in kilogram per square meter (kg/m\^2) |
| Change in Waist Circumference | From baseline (week 0) to end of treatment (week 44) | Measured in centimeter (cm) |
| Change in Systolic Blood Pressure | From baseline (week 0) to end of treatment (week 44) | Measured in millimeter of mercury (mmHg) |
| Change in Diastolic Blood Pressure | From randomisation (week 0) to end of treatment (week 44) | Measured in mmHg |
| Change in Fasting Plasma Glucose | From baseline (week 0) to end of treatment (week 44) | Measured as milligrams per decilitre (mg/dL) |
| Change in Fasting Serum Insulin | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in Total Cholesterol | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in High-density Lipoprotein (HDL) Cholesterol | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in Low-density Lipoproteins (LDL) Cholesterol | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in Very Low-density Lipoproteins (VLDL) Cholesterol | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in Triglycerides | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in Free Fatty Acids | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in High Sensitivity C-reactive Protein (hsCRP) | From baseline (week 0) to end of treatment (week 44) | Measured as ratio to baseline |
| Change in waist-height ratio (WtHR) | From baseline (week 0) to end of treatment (week 44) | — |
| Number of Treatment Emergent Adverse Events(TEAE's) | From baseline (week 0) to end of treatment (week 44) | Measured as count of events |
| Number of Treatment Emergent Serious Adverse Events(TESAE's) | From baseline (week 0) to end of study (week 51) | Measured as count of events |
| AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State | Week 20 | Measured as hours\*nanomoles per litre (h\*nmol/L) |
| Change in Glycated Haemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 44) | Measured in percentage point (%-point) |
| Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg | Week 20 | Measured as nanomoles per litre (nmol/L) |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent | At end of treatment (week 44) | Measured as count of participants |
Countries
China
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed