420
Participants
Start Date
October 1, 2025
Primary Completion Date
August 1, 2029
Study Completion Date
August 1, 2029
Mazdutide
Mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week. The starting dose is 2.0 mg administered once weekly (QW). Based on individual patient tolerance, the dose should be gradually increased to the target therapeutic dose of 4.0 mg QW over a period of 4 to 12 weeks. The protocol permits adaptive dose escalation up to 6.0 mg weekly when clinically indicated. For participants unable to tolerate dose increases, treatment continue at their maximum tolerated dose. The total intervention duration is 76 weeks.
Placebo
Placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week. The starting dose is 2.0 mg administered once weekly (QW). Based on individual patient tolerance, the dose should be gradually increased to the target therapeutic dose of 4.0 mg QW over a period of 4 to 12 weeks. The protocol permits adaptive dose escalation up to 6.0 mg weekly when clinically indicated. For participants unable to tolerate dose increases, treatment continue at their maximum tolerated dose. The total intervention duration is 76 weeks.
Department of Endocrinology, Huadong Hospital Affiliated to Fudan University, Shanghai
Department of Endocrinology, Shanghai General Hospital, Shanghai
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing
Department of Endocrinology, Xiangya Hospital of Central South University, Changsha
Department of Endocrinology, Changzhou No.2 People's Hospital, Changzhou
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing
Nanjing First Hospital, Nanjing Medical University
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Xiangya Hospital of Central South University
OTHER
Huadong Hospital
OTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Changzhou No.2 People's Hospital
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER