Clinical Trial

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

Study acronym: SMART
Not Yet Recruiting
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Summary
The SMART study is a 96-week, multicenter, randomized, double-blind, placebo-controlled superiority clinical trial. A total of 256 severe obesity patients are randomized 1:1 to either receive the bariatric surgery plus GCG/GLP-1 dual receptor agonist group (receiving sleeve gastrectomy followed by subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the bariatric surgery plus placebo group (receiving matched procedure plus placebo injections). The primary objective is to evaluate the potential enhancing weight reduction effects of the combination therapy with bariatric surgery and mazdutide measured by the percentage change of excess weight loss.
Trial Details
NCT Number NCT07135141
Lead Sponsor Beijing Friendship Hospital
Conditions Severe Obesity
Enrollment 256 participants
Start Date 2025-09-30
Primary Completion 2027-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-21