ERCG vs Intensive Lifestyle Intervention for Weight Regain After GLP-1 RA Discontinuation

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic Radial Compression Gastroplasty (ERCG): Participants will undergo Endoscopic Radial Compression Gastroplasty (ERCG) within 3-7 days after baseline assessment and randomization. The procedure will be performed under intravenous sedation or general anesthesia according to institutional standards. Diagnostic upper gastrointestinal endoscopy will be performed to assess the esophagus and stomach and to exclude contraindications. Specialized clips will be placed at the predefined target gastric area according to the standardized operating procedure and individual anatomy to create radial gastric compression and reduce effective gastric volume. Protocol specifies the procedure at Week 0/randomization, within 3-7 days after baseline assessment, with ≥6 hours fasting for solids and ≥2 hours for clear liquids.

Intensive Lifestyle Intervention (ILI): Participants will receive a structured intensive lifestyle intervention consisting of nutritional counseling, exercise guidance, and behavioral support. The dietary intervention will include an individualized structured diet plan with an energy target of approximately 500-750 kcal/day below estimated maintenance requirements and nutritional follow-up every 4 weeks. Exercise guidance will target at least 150 minutes per week of moderate-intensity aerobic activity, with individualized exercise recommendations when feasible. Participants will maintain exercise records. Behavioral support including goal setting, self-monitoring, problem solving, and relapse prevention will be given.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Percentage of Total Body Weight Loss (%TBWL) at Week 12 — Weeks 12 after randomization
  Percentage of total body weight loss (%TBWL) at Week 12 relative to randomization, calculated as \[(body weight at randomization- Week 12 body weight) / body weight at randomization\] × 100%.

Trial sites (1)

More Affiliated Hospital to Academy of Military Medical Sciences trials in China

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