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Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity
Sponsor: Beijing Friendship Hospital
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.
Official title: Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity:A Multicenter, Randomized, Double-Blind, Placebo-Controlled Superiority Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
256
Start Date
2025-09-30
Completion Date
2029-09-30
Last Updated
2025-08-21
Healthy Volunteers
No
Conditions
Interventions
Sleeve gastrectomy plus early mazdutide initiation
After sleeve gastrectomy is preformed, mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg (4.0 mg → 6.0 mg)weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.
Sleeve gastrectomy followed with early mazdutide placebo initation
After sleeve gastrectomy is preformed, mazdutide placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg placebo, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg placebo(4.0 mg → 6.0 mg) weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.
Locations (14)
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Peking University People's Unviersity
Beijing, China
The Third Hospital of Central South University
Changsha, China
West China Hospital of Sichuan University
Chengdu, China
The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital)
Guangzhou, China
Qilu Hospital of Shandong University
Jinan, China
Kunming First People's Hospital
Kunming, China
Nanjing Drum Tower Hospital
Nanjing, China
Huadong Hospital affiliated to Fudan University
Shanghai, China
Shanghai Sixth People's Hospital to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Tianjin Medical University General Hospital
Tianjing, China
Zhongnan Hospital of Wuhan University
Wuhan, China