Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity
As posted on ClinicalTrials.gov (NCT03611582), updated at source Nov 11, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Measure | Semaglutide 2.4 mgn=407 | Placebon=204 |
|---|---|---|
| In-trial observation period | -16.5(10.1) | -5.8(7.7) |
| On-treatment observation period | -17.6(9.6) | -6.1(7.6) |
| Measure | Semaglutide 2.4 mgn=407 | Placebon=204 |
|---|---|---|
| In-trial observation period: Yes | 323 | 90 |
| In-trial observation period: No | 50 | 99 |
| On-treatment observation period: Yes | 300 | 82 |
| On-treatment observation period: No | 34 | 82 |
Percent of participants affected, week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.. The most common events the registry lists.
| Event | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Any serious event | 9.1% | 2.9% |
| Nausea | 58.2% | 22.1% |
| Constipation | 36.9% | 24.5% |
| Diarrhoea | 36.1% | 22.1% |
| Vomiting | 27.3% | 10.8% |
| Nasopharyngitis | 22.1% | 24% |
| Upper respiratory tract infection | 20.9% | 21.6% |
| Headache | 19.2% | 9.8% |
| Abdominal pain | 13% | 4.9% |
| Back pain | 13% | 10.8% |
| Dizziness | 12.8% | 5.4% |
| Fatigue | 12.8% | 7.4% |
| Sinusitis | 9.6% | 12.7% |
| Flatulence | 11.5% | 11.3% |
| Abdominal distension | 10.1% | 9.8% |
| Gastroenteritis viral | 10.1% | 6.4% |
| Urinary tract infection | 10.1% | 4.9% |
| Arthralgia | 9.6% | 9.3% |
| Dyspepsia | 8.8% | 4.9% |
| Eructation | 8.8% | 0.5% |
| Decreased appetite | 8.6% | 3.4% |
| Abdominal pain upper | 8.1% | 2.5% |
| Gastroenteritis | 6.9% | 5.9% |
| Influenza | 6.6% | 5.4% |
| Pain in extremity | 4.2% | 6.4% |
| Gastrooesophageal reflux disease | 6.1% | 2% |
| Measure | Semaglutide 2.4 mgn=373 | Placebon=189 |
|---|---|---|
| Yes | 281 | 51 |
| No | 92 | 138 |
| Measure | Semaglutide 2.4 mgn=373 | Placebon=189 |
|---|---|---|
| Yes | 208 | 25 |
| No | 165 | 164 |
| Measure | Semaglutide 2.4 mgn=373 | Placebon=189 |
|---|---|---|
| Yes | 133 | 7 |
| No | 240 | 182 |
| Semaglutide 2.4 mgn=371 | Placebon=189 |
|---|---|
| -15.2(10.2) | -6.1(8.6) |
| Semaglutide 2.4 mgn=372 | Placebon=188 |
|---|---|
| -6(14) | -2(15) |
| Measure | Semaglutide 2.4 mgn=407 | Placebon=204 |
|---|---|---|
| Change in physical functioning score (SF-36) | 2.5(5.7) | 1.7(5.7) |
| Change in SF-36: Role-Physical score | 1.6(6.5) | 1.5(6.7) |
| Change in SF-36: Bodily Pain score | 1.3(7.1) | 0.6(8.3) |
| Change in SF-36: General Health score | 3.4(6.6) | 1.9(6.4) |
| Change in SF-36: Vitality score | 2.0(8.2) | 0.9(7.8) |
| Change in SF-36: Social Functioning score | 0.1(6.6) | -1.2(8.0) |
| Change in SF-36: Mental Health score | -0.5(6.0) | -1.5(7.1) |
| Change in SF-36: Physical component summary | 3.2(6.0) | 2.6(6.5) |
| Change in SF-36: Mental component summary | -0.9(6.0) | -2.2(8.0) |
| Change in SF-36: Role-Emotional score | -0.6(5.6) | -1.5(7.7) |
| Semaglutide 2.4 mgn=373 | Placebon=189 |
|---|---|
| -17.5(11.4) | -6.2(8.6) |
| Semaglutide 2.4 mgn=373 | Placebon=189 |
|---|---|
| -6.2(4.0) | -2.2(3.1) |
| Semaglutide 2.4 mgn=369 | Placebon=184 |
|---|---|
| -0.5(0.3) | -0.3(0.2) |
| Semaglutide 2.4 mgn=369 | Placebon=184 |
|---|---|
| -5.8(3.1) | -3.1(2.5) |
| Semaglutide 2.4 mgn=355 | Placebon=176 |
|---|---|
| -7.3(10.9) | -1.1(10.6) |
| Semaglutide 2.4 mgn=346 | Placebon=170 |
|---|---|
| 0.68(67.4) | 0.84(50.6) |
This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active. The participant will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. The participant will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. For the first 2 months the participant will be on a low calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for each day. The study will last for about 1.5 years. The participant will have 32 clinic visits with the study doctor.
Inclusion Criteria: * Male or female, age more than or equal to 18 years at the time of signing informed consent * Body mass index more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.