ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)
1 other identifier
interventional
420
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2026
Typical duration for not_applicable obesity
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 8, 2026
December 1, 2025
2.7 years
March 18, 2026
April 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change of body weight
From randomization to Week 52
Secondary Outcomes (13)
Change in body mass index (BMI)
From randomization to Week 52
Change in waist circumference
From randomization to Week 52
Change in total body fat
From randomization to Week 52
Change in abdominal visceral fat area
From randomization to Week 52
Change in hepatic fat content
From randomization to Week 52
- +8 more secondary outcomes
Study Arms (4)
Placebo plus Intensive Lifestyle Intervention
EXPERIMENTALAfter 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.
Mazdutide
EXPERIMENTALAfter 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.
Mazdutide Plus Intensive Lifestyle Intervention
EXPERIMENTALAfter 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.
Standard Health Education (Control)
NO INTERVENTIONAfter 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.
Interventions
Mazdutide is administered subcutaneously at 3.0 mg once weekly for 52 weeks during the weight maintenance period.
A structured intensive lifestyle intervention including individualized dietary counseling, physical activity guidance, and behavioral modification support for 52 weeks during the weight maintenance period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000, China
The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University
Suzhou, Jiangsu, 215000, China
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai Tenth People's Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, 200000, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2026
First Posted
April 8, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 8, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After publication.
- Access Criteria
- IPD and supporting information will be avaible to researchers upon reasonable request (e.g. with a practical and meaningful research proposal).
All IPD that underlie results in a publication.