Lifestyle program plus low-dose mazdutide to keep weight off

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls adults with obesity who have achieved initial weight loss after intensive high-dose mazdutide treatment and randomizes them to one year of intensive lifestyle intervention, reduced-dose mazdutide (3.0 mg once weekly), or the combination. The primary focus is on weight maintenance over 12 months following initial pharmacologic-induced weight reduction. The trial is conducted at several major hospitals in China and includes regular clinic visits and lifestyle counseling sessions alongside medication as assigned. Results aim to inform practical strategies for sustaining weight loss while addressing cost and safety concerns of long-term medication use.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Provincial Hospital, Affiliated to Fuzhou University
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Nanjing First Hospital, Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: JINGJING JIANG, MD, PhD
• Email: jiang.jingjing@zs-hospital.sh.cn
• Phone: 86-21-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.