NCT05073835

Semaglutide 2.4 mg in Patients With Poor Weight-loss

BARI-STEP:A Double-blinded, Randomised, Placebo-controlled Trial of Semaglutide 2.4 mg in Patients With Poor Weight-loss Following Bariatric Surgery.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obesity
• Diabetes
• Metabolic Syndrome

Interventions

Type	Name	Description
DRUG	Semaglutide 3 mg	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).
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2021-10-12
• Last updated: 2024-12-06

Locations

1 site across 1 country: United Kingdom