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A double-blinded, randomised, placebo-controlled trial of semaglutide 3.0 mg/ml in patients with poor weight-loss following bariatric surgery. The primary aim of this trial is to determine whether, and the extent to which, 68 weeks of subcutaneous semaglutide 3.0 mg/ml causes greater percentage weight loss (%WL), reduction in adiposity, improvement in metabolic and inflammatory indices and health-related quality of life (HRQoL) than placebo, in patients with poor weight loss following gastric bypass or sleeve gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Semaglutide 2.4mg/week subcutaneous injection for 68 weeks. The treatment includes an initial 16-week escalation phase followed by 52 weeks of treatment at study dose, i.e., 2.4mg/week. |
|
| Control | Placebo Comparator | Placebo administration, once weekly, subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 3 mg | Drug | Semaglutide 2.4 mg/week, subcutaneous injection. Treatment dose: 16 weeks of dose escalation + 52 weeks of study dose (i.e., 2.4 mg/week). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Percentage of total weight loss | 68 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| body weight reduction ≥10% | To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥10% | 68 weeks |
| body weight reduction ≥15% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janine Makaronids | London | WC1E 6JF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42174253 | Derived | Stanley C, Mallik R, Hamid N, Jassil FC, Reuven V, Ruwona T, Dicken SJ, Qamar S, Norton B, Kingett H, Pucci A, Magee C, Boniface D, Batterham RL, Devalia K, Mok J, Elkalaawy M, Loy J, Jenkinson A, Markakis H, Adamo M, Brown A, Makaronidis J. Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial. Nat Med. 2026 May 22. doi: 10.1038/s41591-026-04416-4. Online ahead of print. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Phase 3b, double-blinded, randomised, parallel group trial
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double blinded: both participants and study doctors will be blind to group allocation
| Placebo | Drug | Placebo |
|
To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥15% |
| 68 weeks |
| body weight reduction ≥20% | To compare the percentage of participants receiving subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo who after 68 weeks achieve a body weight reduction ≥20% | 68 weeks |
| Change in circulating HbA1c levels | The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c | 68 weeks |
| Change in circulating HbA1c levels in participants with pre-diabetes at baseline | The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c in participants with pre-diabetes at baseline | 68 weeks |
| Change in circulating HbA1c levels in participants with T2D at baseline | The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HbA1c in participants with diabetes at baseline | 68 weeks |
| Systolic and diastolic BP | The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon BP | 68 weeks |
| Systolic and diastolic BP in participants with pre-existing hypertension | The effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon BP in participants with pre-existing hypertension | 68 weeks |
| pharmacological agents required for the management of hypertension | The number of pharmacological agents required for the management of hypertension in participants with pre-existing hypertension | 68 weeks |
| Change in circulating lipids | To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon circulating lipids | 68 weeks |
| Change in circulating HsCRP and inflammatory cytokines | To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon inflammatory markers | 68 weeks |
| Changes in food craving scores assessed through power of food questionnaire | To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon food cravings | 68 weeks |
| Changes in HRQoL | To compare the effect of 68 weeks of subcutaneous semaglutide 3.0 mg/ml at a dose of 2.4mg per week versus placebo administration upon HRQoL | 68 weeks |
| GLP-1 levels | To investigate the relationship between fasted and meal-stimulated active GLP-1 levels at baseline and %WL at 68 weeks | 68 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |