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Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy
Phase 3 trial testing Saxenda in Obesity in 46 participants. Completed in 30 May 2024.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 46 |
| Start date | 22 June 2017 |
| Primary completion | 4 October 2023 |
| Estimated completion | 30 May 2024 |
| Sites | 1 location across United States |
Mayo Clinic
Adults 20 to 65, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subjects calculated weight in kilograms
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 127 | ± 7 |
| Sleeve Gastrectomy Placebo | 130 | ± 8 |
| Roux-en-Y Gastric (RYGB) | 126 | ± 4 |
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 75 | ± 8 |
| Sleeve Gastrectomy Placebo | 107 | ± 10 |
| Roux-en-Y Gastric (RYGB) | 98 | ± 7 |
Systolic blood pressure (top number of blood pressure reading)
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 129 | ± 4 |
| Sleeve Gastrectomy Placebo | 130 | ± 7 |
| Roux-en-Y Gastric (RYGB) | 123 | ± 4 |
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 112 | ± 7 |
| Sleeve Gastrectomy Placebo | 128 | ± 1 |
| Roux-en-Y Gastric (RYGB) | 122 | ± 7 |
Diastolic blood pressure (bottom number of blood pressure reading)
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 86 | ± 3 |
| Sleeve Gastrectomy Placebo | 83 | ± 6 |
| Roux-en-Y Gastric (RYGB) | 76 | ± 2 |
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 84 | ± 4 |
| Sleeve Gastrectomy Placebo | 93 | ± 13 |
| Roux-en-Y Gastric (RYGB) | 82 | ± 3 |
LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL.
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 114 | ± 9 |
| Sleeve Gastrectomy Placebo | 101 | ± 11 |
| Roux-en-Y Gastric (RYGB) | 99 | ± 5 |
| Group | Value | 95% CI |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 106 | ± 20 |
| Sleeve Gastrectomy Placebo | 68 | ± 1 |
| Roux-en-Y Gastric (RYGB) | 90 | ± 7 |
Time frame: Adverse Events were collected from baseline to end of study, approximately 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Sleeve Gastrectomy Saxenda | Sleeve Gastrectomy Placebo | Roux-en-Y Gastric (RYGB) |
|---|---|---|---|---|
| Seizure | Nervous system disorders | — | — | — |
| Reaction | System | Sleeve Gastrectomy Saxenda | Sleeve Gastrectomy Placebo | Roux-en-Y Gastric (RYGB) |
|---|---|---|---|---|
| Nausea | General disorders | — | — | — |
| Vomiting | General disorders | — | — | — |
| Hgb < 11.5 g/dL | Blood and lymphatic system disorders | — | — | — |
Most-reported serious reactions: Seizure.
Data from ClinicalTrials.gov NCT03115424 adverse events section.
Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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