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NOT YET RECRUITING
NCT07135141
NA

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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