Phase 4Not yet recruiting
Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery
Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery: a Randomized, Double-blind Strategy Trial
- Sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt (Government)
- Enrolment
- 100 planned
- Conditions
- Morbid Obesity
- Interventions
- Semaglutide weekly injection; Placebo
- Ages
- adults, older adults
- Registry
- NCT07859189
Full record on ClinicalTrials.gov
From the registry
Roughly one patient in five never reaches the expected weight loss after MBS, and long-term regain after SG is well documented. These patients are identifiable at the 12-month visit. Today they are watched, coached, and treated only when failure is established. Whether the drug works in this group is no longer the question. BARI-STEP, published this year, randomized 70 patients with less than 20% weight loss after gastric bypass (including one-anastomosis) or sleeve gastrectomy, a mean of seven years after surgery, to semaglutide 2.4 mg or placebo: 18.0% loss versus 0.4% gain at 68 weeks, an adjusted difference of 19.1 percentage points. Its population was mixed, 55.7% with recurrent weight gain and 44.3% with suboptimal initial response, and its exploratory comparison found no difference in drug response between the two presentations. BARI-OPTIMISE showed the same direction with liraglutide, as did a randomized trial after gastric banding. Efficacy is settled. Timing is not. BARI-STEP recruited patients a mean of seven years past surgery, after failure had hardened. No trial has…
Primary outcomes
- Percentage total weight loss
History
Primary completion expected
Expected to start
Registered