ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

NCT07517042 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Not applicable

Started

2026-06-10

Last updated

2026-09-15

Condition(s) studied

ObesityWeight Control

Investigational drug(s) / intervention(s)

MazdutideIntensive Lifestyle Intervention

Mazdutide: Mazdutide is administered subcutaneously at 3.0 mg once weekly for 52 weeks during the weight maintenance period.

Intensive Lifestyle Intervention: A structured intensive lifestyle intervention including individualized dietary counseling, physical activity guidance, and behavioral modification support for 52 weeks during the weight maintenance period.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases; * Severe hepatic impairment (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>3 times the upper limit of normal), severe renal impairment, or end-stage renal disease (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²); * Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months; * Severe gastrointestinal diseases, or a history of gastrointestinal resection surgery within the past year; * Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury; * Obesity secondary to other causes, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, or acromegaly; drug-induced obesity, such as obesity related to the use of antipsychotic agents or glucocorticoids; * Current smoker or habitual smoking within the past 3 months; * Current use of other weight-loss medications or a history of bariatric surgery; * Previously diagnosed diabetes mellitus or current use of glucose-lowering medications; * Pregnant or breastfeeding women, or women planning pregnancy during the study period; * Inability to complete a 2-year follow-up due to health conditions, relocation, or other reasons; * Any other condition deemed by the investigator to make the participant unsuitable for participation in the study.

Primary outcome measure(s)

Percentage change of body weight — From randomization to Week 52

Trial sites (13)

Facility	City	Region	Status
The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting
Fujian Provincial Hospital, Affiliated to Fuzhou University	Fuzhou	Fujian	Recruiting
The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	Recruiting
Zhongnan Hospital of Wuhan University	Wuhan	Hubei	Recruiting
Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu	Recruiting
The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University	Suzhou	Jiangsu	Recruiting
Huadong Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting
Shanghai Tenth People's Hospital, School of Medicine, Tongji University	Shanghai	Shanghai Municipality	Recruiting
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	Recruiting
Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	Recruiting
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07517042 on ClinicalTrials.gov ↗ ← All trials in China