A Randomized Controlled Study of Dose-tapering Regimen of Semaglutide for Weight-Loss Maintenance in Adults With Overweight or Obesity

What this study is testing ClinicalTrials.gov NCT07783854 ↗

Description as written by the study sponsor.

The goal of this clinical trial is to determine whether a semaglutide dose-tapering regimen is non-inferior to a treatment-dose maintenance regimen for weight-loss maintenance in adults with overweight or obesity who have achieved stable weight loss. This trial will also evaluate the safety of the dose-tapering regimen. The primary research questions are: Is the semaglutide dose-tapering regimen non-inferior to the treatment-dose maintenance regimen for weight-loss maintenance at 24 weeks? Can the dose-tapering regimen alleviate adverse events and offer a more personalized, sustainable pathway for medication discontinuation? Researchers will compare the semaglutide dose-tapering regimen against a treatment-dose maintenance regimen to assess whether the tapering strategy preserves weight loss and improves cardiometabolic markers. Participants will: Be randomly assigned to receive either the semaglutide dose-tapering regimen or the treatment-dose maintenance regimen for 24 weeks. Complete a 24-week follow-up period after medication discontinuation (48 weeks total study duration). Attend scheduled clinic visits for physical examinations and laboratory testing to assess weight, BMI, waist circumference, cardiometabolic markers (including blood glucose, blood pressure, and lipids), and to monitor adverse events.

Treatments tested

• Semaglutide Dose-Tapering Regimen Drug

  Semaglutide dose-tapering regimen: Subjects initiate from a stable entry dose of 1.7 mg per week, with a 25% relative dose reduction implemented every 8 weeks over the 24-week intervention period.

• Semaglutide Maintenance-Dose Regimen Drug

  Subjects keep the stable entry dose of 1.7 mg once-weekly without any dose modification during the full 24-week intervention period.