Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

NANot yet recruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2029

Conditions
Severe Obesity
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.

Trial Locations (14)

Unknown

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

All Listed Sponsors
lead

Beijing Friendship Hospital

OTHER

NCT07135141 - Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity | Biotech Hunter | Biotech Hunter