NCT07908823Not yet recruiting
ERCG vs Intensive Lifestyle Intervention for Weight Regain After GLP-1 RA Discontinuation
Endoscopic Radial Compression Gastroplasty (ERCG) Versus Intensive Lifestyle Intervention (ILI) for Management of Weight Regain After Discontinuation of GLP-1 Receptor Agonists: An Open-Label Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This randomized controlled trial aims to evaluate the efficacy and safety of Endoscopic Radial Compression Gastroplasty (ERCG) in mitigating weight regain following discontinuation of glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Approximately 60 adults with prior GLP-1 RA use and confirmed weight rebound after treatment cessation will be randomized 1:1 to either ERCG combined with Intensive Lifestyle Intervention (ILI), or ILI alone. The primary outcome is the between-group difference in percent Total Body Weight Loss (%TBWL) from randomization to week 12; secondary outcomes include %TBWL at 24 and 52 weeks; changes in Body Mass Index (BMI), body composition, metabolic parameters (e.g., glycemic control, lipid profile), and quality of life; adherence to ILI; and adverse events, all assessed over 12, 24 and 52-week follow-up period. This study will generate preliminary evidence on the effectiveness and safety of ERCG as an intervention for weight regain after GLP-1 RA withdrawal, and the results will inform the design of future confirmatory trials, including sample size and endpoint selection.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Diseases
- Obesity
- NCT number
- NCT07908823
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 5 Oct 2026 to the primary completion date, 31 May 2027
- 1 site 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.
Who the study is looking for
- Adults aged 18-65 years.
- Body mass index (BMI) ≥27.5 kg/m² at screening.
- Prior treatment with a GLP-1 receptor agonist (GLP-1 RA) for at least 12 weeks, with discontinuation more than 3 months before randomization.
- Documented weight regain of ≥3.0 kg after GLP-1 RA discontinuation.
- Adequate cardiopulmonary function and fitness for anesthesia and ERCG, as determined by clinical assessment.
- Willingness and ability to participate in the assigned intervention and complete 52 weeks of follow-up.
- Provision of written informed consent. Exclusion Criteria
- Use of any GLP-1 RA or another medication prescribed for weight loss within three months before randomization.
- Previous bariatric surgery or endoscopic bariatric procedure.
- An untreated or inadequately controlled secondary cause of obesity.
- Upper gastrointestinal anatomy or disease that, in the investigator's judgment, would make ERCG unsafe or technically infeasible, including a hiatal hernia \>3 cm, esophageal stricture, or active peptic ulcer disease.
- Clinically significant coagulopathy, including an international normalized ratio (INR) \>1.5, or anticoagulant therapy that cannot be safely interrupted for the procedure.
- Pregnancy or breastfeeding.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fifth medical center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.