256
Participants
Start Date
September 30, 2025
Primary Completion Date
September 30, 2027
Study Completion Date
September 30, 2029
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.
Beijing Friendship Hospital, Capital Medical University, Beijing
Beijing Hospital, Beijing
Peking University People's Unviersity, Beijing
The Third Hospital of Central South University, Changsha
West China Hospital of Sichuan University, Chengdu
The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital), Guangzhou
Qilu Hospital of Shandong University, Jinan
Kunming First People's Hospital, Kunming
Nanjing Drum Tower Hospital, Nanjing
Huadong Hospital affiliated to Fudan University, Shanghai
Shanghai Sixth People's Hospital to Shanghai Jiao Tong University School of Medicine, Shanghai
The Second Hospital of Hebei Medical University, Shijiazhuang
Tianjin Medical University General Hospital, Tianjing
Zhongnan Hospital of Wuhan University, Wuhan
Beijing Friendship Hospital
OTHER