NCT07517042Recruiting
ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management
Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 10 Jun 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Obesity
- NCT number
- NCT07517042
What you commit to
- Study type: Interventional
- Planned participants: 420
- From 10 Jun 2026 to the primary completion date, 31 Dec 2028
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases;
- 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 use of other weight-loss medications or a history of bariatric surgery;
- 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.
Lab values
- 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);
- Previously diagnosed diabetes mellitus or current use of glucose-lowering medications;
Other
- Current smoker or habitual smoking within the past 3 months;
- Pregnant or breastfeeding women, or women planning pregnancy during the study period;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Fujian Provincial Hospital Affiliated to Fuzhou University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Affiliated Hospital of Southwest Medical University Coordinator of this site? Confirm its status | Luzhou | China | Recruiting |
| Nanjing First Hospital, Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Huadong Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Tenth People's Hospital, School of Medicine, Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.