Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
As posted on ClinicalTrials.gov (NCT03548935), updated at source Nov 19, 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=1,306 | Placebon=655 |
|---|---|---|
| In-trial observation period | -15.6(10.1) | -2.8(6.5) |
| On-treatment observation period | -16.9(9.4) | -3.1(6.4) |
| Measure | Semaglutide 2.4 mgn=1,306 | Placebon=655 |
|---|---|---|
| In-trial observation period: Yes | 1047 | 182 |
| In-trial observation period: No | 165 | 395 |
| On-treatment observation period: Yes | 978 | 165 |
| On-treatment observation period: No | 81 | 334 |
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 | Sema 2.4 mg | Placebo |
|---|---|---|
| Any serious event | 9.8% | 6.4% |
| Nausea | 44.1% | 17.4% |
| Diarrhoea | 31.5% | 15.9% |
| Vomiting | 24.6% | 6.6% |
| Constipation | 23.4% | 9.5% |
| Nasopharyngitis | 21.5% | 20.3% |
| Headache | 15.2% | 12.2% |
| Upper respiratory tract infection | 8.7% | 12.2% |
| Dyspepsia | 10.3% | 3.5% |
| Abdominal pain | 9.7% | 5.5% |
| Abdominal pain upper | 9.6% | 5.3% |
| Influenza | 6.8% | 9.6% |
| Decreased appetite | 9.5% | 3.4% |
| Eructation | 8.6% | 0.5% |
| Back pain | 8.1% | 8.1% |
| Fatigue | 8% | 4.3% |
| Dizziness | 7.5% | 3.5% |
| Abdominal distension | 7.4% | 4.7% |
| Arthralgia | 6.2% | 6.6% |
| Gastrooesophageal reflux disease | 6.3% | 3.1% |
| Gastroenteritis | 6.2% | 4.6% |
| Sinusitis | 5.4% | 5.5% |
| Urinary tract infection | 5.2% | 4.3% |
| Cough | 3.1% | 5% |
| Measure | Semaglutide 2.4 mgn=1,212 | Placebon=577 |
|---|---|---|
| Yes | 838 | 69 |
| No | 374 | 508 |
| Measure | Semaglutide 2.4 mgn=1,212 | Placebon=577 |
|---|---|---|
| Yes | 612 | 28 |
| No | 600 | 549 |
| Measure | Semaglutide 2.4 mgn=1,212 | Placebon=577 |
|---|---|---|
| Yes | 388 | 10 |
| No | 824 | 567 |
| Semaglutide 2.4 mgn=1,210 | Placebon=575 |
|---|---|
| -14.1(9.6) | -4.4(6.9) |
| Semaglutide 2.4 mgn=1,210 | Placebon=574 |
|---|---|
| -7(14) | -1(13) |
| Measure | Semaglutide 2.4 mgn=1,195 | Placebon=566 |
|---|---|---|
| Change in physical functioning score (SF-36) | 2.3(6.6) | 0.4(7.4) |
| Change in SF-36 (role-physical score) | 1.1(7.2) | -0.2(7.2) |
| Change in SF-36 (bodily pain score) | 0.5(8.2) | -1.3(8.9) |
| Change in SF-36 (general health score) | 2.0(7.2) | -0.6(7.1) |
| Change in SF-36 (vitality score) | 0.7(8.0) | -1.3(7.9) |
| Change in SF-36 (social functioning score) | -0.3(6.6) | -1.4(7.4) |
| Change in SF-36 (role-emotional score) | -0.9(7.3) | -1.5(7.6) |
| Change in SF-36 (mental health score) | -0.8(7.0) | -1.7(7.4) |
| Change in SF-36 (physical component summary) | 2.4(6.7) | 0.2(7.1) |
| Change in SF-36 (mental component summary) | -1.5(7.1) | -2.1(7.7) |
| Measure | Semaglutide 2.4 mgn=1,193 | Placebon=566 |
|---|---|---|
| Change in physical function domain score | 15.0(21.6) | 6.0(21.1) |
| Change in physical domain score | 14.0(20.0) | 5.0(19.5) |
| Change in psychosocial domain score | 17.4(19.2) | 6.9(17.8) |
| Change in total score | 16.2(17.8) | 6.3(16.8) |
| Semaglutide 2.4 mgn=1,212 | Placebon=577 |
|---|---|
| -16.1(10.6) | -2.9(7.2) |
| Semaglutide 2.4 mgn=1,212 | Placebon=577 |
|---|---|
| -5.8(3.8) | -1.0(2.5) |
| Semaglutide 2.4 mgn=1,197 | Placebon=563 |
|---|---|
| -0.5(0.3) | -0.2(0.3) |
| Semaglutide 2.4 mgn=1,197 | Placebon=563 |
|---|---|
| -5.1(3.3) | -1.8(3.0) |
| Semaglutide 2.4 mgn=1,175 | Placebon=557 |
|---|---|
| -9.2(10.9) | -0.4(12.7) |
This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants 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. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.
Inclusion Criteria: Main phase: * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm 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 Extension phase: * Informed consent for the extension phase obtained before any trial related activities for the extension phase * On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo Exclusion Criteria: Main phase: * Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records Extension phase: * Female who is pregnant or intends to become pregnant during the extension phase * Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.