Actively Recruiting
ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Led by Shanghai Zhongshan Hospital · Updated on 2026-04-08
420
Participants Needed
13
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women aged 18 years or older
- Simple obesity with a body mass index (BMI) of 28.0 to 45.0 kg/m²
- Able and willing to provide written informed consent
You will not qualify if you...
- Active pulmonary tuberculosis, malignant tumors, HIV infection, or other serious infectious or systemic diseases
- Severe liver impairment (AST or ALT more than 3 times upper limit of normal), severe kidney impairment, or end-stage kidney disease (eGFR less than 30 mL/min/1.73 m²)
- Severe cardiovascular diseases, including angina, heart attack, or stroke within the past 6 months
- Severe gastrointestinal diseases or history of gastrointestinal surgery within the past year
- Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury
- Obesity caused by other conditions like Cushing's syndrome, hypothyroidism, hypothalamic obesity, acromegaly, or drug-related obesity
- Current smoker or habitual smoking within the past 3 months
- Current use of other weight-loss medications or history of weight-loss surgery
- Diagnosed diabetes or current use of glucose-lowering medications
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unable to complete a 2-year follow-up due to health, relocation, or other reasons
- Any condition that the investigator judges makes participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
2
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian, China, 350000
Actively Recruiting
3
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
4
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Actively Recruiting
5
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
6
The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
7
Huadong Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
8
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
9
Shanghai Tenth People's Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
10
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
11
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Actively Recruiting
12
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
13
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
J
JINGJING JIANG, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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