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Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. In addition, the high cost and potential adverse effects of weight-loss medications restrict their prolonged use, and it is unclear whether low dose medication, intensive life style intervention or together can serve as an effective strategy for weight maintenance. This randomized controlled trial aims to evaluate the effectiveness of a 1-year intensive lifestyle intervention, a reduced dose of mazdutide (3.0 mg once weekly), or their combination in weight maintenance among individuals with obesity who have achieved initial weight loss after intensive treatment with high dose mazdutide. The study seeks to provide high-quality clinical evidence to inform long-term weight maintenance strategies after weight loss in patients with obesity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult men or women aged 18 years or older;

• Simple obesity, defined as a body mass index (BMI) of 28.0-45.0 kg/m²;

• Able and willing to provide written informed consent.

Locations
Other Locations
China
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Fujian Provincial Hospital, Affiliated to Fuzhou University
RECRUITING
Fuzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
The Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
Nanjing First Hospital, Nanjing Medical University
RECRUITING
Nanjing
Huadong Hospital, Fudan University
RECRUITING
Shanghai
Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai Tenth People's Hospital, School of Medicine, Tongji University
RECRUITING
Shanghai
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University
RECRUITING
Suzhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Contact Information
Primary
JINGJING JIANG, MD, PhD
jiang.jingjing@zs-hospital.sh.cn
86-21-64041990
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 420
Treatments
Experimental: Placebo plus Intensive Lifestyle Intervention
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive placebo once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
Experimental: Mazdutide
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly for 52 weeks during the weight maintenance period.
Experimental: Mazdutide Plus Intensive Lifestyle Intervention
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
No_intervention: Standard Health Education (Control)
After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive standard health education only for 52 weeks during the weight maintenance period.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov