Overweight, Obesity
Conditions
Brief summary
This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.
Interventions
DRUGSemaglutide
Semaglutide tablets orally once daily for 64 weeks.
Semaglutide placebo-matching tablets orally once daily for 64 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 * Greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR * Greater than or equal to 30.0 kg/m\^2 * History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
* A self-reported change in body weight greater than 5 kg (11 pound \[lbs\]) within 90 days before screening irrespective of medical records * HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Body Weight | Baseline (week 0), end of treatment (week 64) | Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented. |
| Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No) | At end of treatment (week 64) | Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No) | At end of treatment (week 64) | Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction. |
| Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No) | At end of treatment (week 64) | Number of participants who achieved ≥ 15% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction. |
| Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No) | At end of treatment (week 64) | Number of participants who achieved ≥ 20% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction. |
| Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) | Baseline (week 0), end of treatment (week 64) | Change in physical function domain score IWQOL-Lite-CT from baseline (week 0) to the end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'. |
| Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No) | Baseline (week 0), end of treatment (week 64) | Number of participants who achieved ≥14.6 in IWQOL-Lite-CT PFD score (Yes/No) from baseline to end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. |
| Change in Body Weight - Kilogram (kg) | Baseline (week 0), end of treatment (week 64) | Change in body weight from baseline (week 0) to end of treatment (week 64) is presented. |
| Change in Body Mass Index (BMI) | Baseline (week 0), end of treatment (week 64) | Change in BMI from baseline (week 0) to end of treatment (week 64) is presented. |
| Change in Waist Circumference | Baseline (week 0), end of treatment (week 64) | Change in waist circumference from baseline (week 0) to end of treatment (week 64) is presented. |
| Change in Systolic Blood Pressure | Baseline (week 0), end of treatment (week 64) | Change in systolic blood pressure from baseline (week 0) to end of treatment (week 64) is presented. |
| Change in Diastolic Blood Pressure | Randomisation (week 0), end of treatment (week 64) | Change in diastolic blood pressure from randomisation (week 0) to end of treatment (week 64) is presented. |
| Change in Glycosylated Haemoglobin (HbA1c) | Baseline (week 0), end of treatment (week 64) | Change in HbA1c from baseline (week 0) to end of treatment (week 64) is presented. |
| Change in Total Cholesterol - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in total cholesterol (measured in millimoles per liter \[mmol/L\]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in VLDL cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in Triglycerides - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in triglycerides (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in Free Fatty Acids - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in free fatty acids (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in high sensitivity C-Reactive Protein (hsCRP) (milligram per litre \[mg/L\]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Change in Fasting Plasma Glucose (FPG) | Baseline (week 0), end of treatment (week 64) | Change in FPG measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 64) is presented. |
| Change in Fasting Serum Insulin - Ratio to Baseline | Baseline (week 0), end of treatment (week 64) | Change in fasting serum insulin measured in picomoles per liter (pmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0). |
| Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no) | From baseline (week 0) to end of treatment (week 64) | Number of participants with BMI \<30 at the end of treatment (week 64) from baseline (week 0) is presented. The outcome measure is applicable for participants with BMI ≥ 30 at baseline (week 0). In the reported data, 'Yes' infers the number of participants who have achieved BMI less than 30, whereas 'No' infers the number of participants who have not achieved BMI less than 30 at week 64. |
| Number of Participants With Change in Glycaemic Status | Baseline (week 0), end of treatment (week 64) | Number of participants with change in glycaemic status from baseline (week 0) to the end of treatment (week 64) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \<5.7%; 2) Pre-diabetes: 5.7% \<= HbA1c \< 6.5% 3) Type 2 diabetes: HbA1c \>=6.5%. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to end of study (week 71) | Number of treatment emergent adverse events from baseline (week 0) to end of study (week 71) is presented. An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. |
| Number of Serious Treatment Emergent Adverse Events | From baseline (week 0) to end of study (week 71) | Number of treatment emergent serious adverse events from baseline (week 0) to end of study (week 71) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event. |
| Change in Pulse | Baseline (week 0), end of treatment (week 64) | Change in pulse from baseline (week 0) to end of treatment (week 64) is presented. |
Countries
Canada, Germany, Poland, United States
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted at 22 sites in 4 countries (Canada, Germany, Poland, and United States).
Pre-assignment details
Participants were randomised in 2:1 ratio to receive once daily oral semaglutide 25 milligram (mg) or placebo matched to semaglutide. The trial had a 64-week treatment period (12 weeks of dose escalation period and 52 weeks of maintenance period) followed by a 7-week follow-up period.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 188 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 22 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 281 Participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 205 | 0 / 102 |
| other Total, other adverse events | 172 / 204 | 79 / 102 |
| serious Total, serious adverse events | 8 / 204 | 9 / 102 |
Outcome results
None listed