An interventional study of Endoscopic Radial Compression Gastroplasty (ERCG) and Intensive Lifestyle Intervention (ILI) in Obesity & Overweight, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Not applicable, Interventional, and Treatment
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.
Obesity is a chronic condition in which weight regain may occur after successful weight loss. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely used for weight management, but some individuals regain weight after treatment is discontinued. Effective treatment strategies for weight regain following GLP-1 RA discontinuation remain limited.
ERCG is a novel endoscopic procedure that reduces gastric volume by apposing the gastric walls using a newly designed clip-and-loop system. Preliminary studies suggest that ERCG may produce clinically meaningful weight loss, but its efficacy and safety specifically in people who have regained weight after GLP-1 RA withdrawal require prospective evaluation.
This is a two-arm, parallel-group, open-label randomized clinical trial. Approximately 60 eligible participants will be randomly assigned in a 1:1 ratio to the ERCG plus ILI or ILI alone. Randomization will be computer-generated, with allocation concealed until assignment. Participants assigned to the ERCG group will undergo ERCG under general anesthesia or deep sedation according to a standardized perioperative protocol.
Both groups will receive the same ILI program from randomization through week 52. The program will include individualized dietary counseling aimed at an approximately 500-750 kcal/day energy deficit when clinically appropriate; a gradual increase in physical activity toward at least 150 minutes per week of moderate-intensity activity, tailored to individual capacity; and behavioral support focused on goal setting, self-monitoring, problem solving, and relapse prevention. Trained study staff will deliver the program using a common intervention manual, with weekly contacts during weeks 1-12, contacts every two weeks during weeks 13-24, and monthly contacts during weeks 25-52. Dietary intake, physical activity, body weight, and attendance will be recorded to assess adherence. Participants in the ERCG group will additionally follow a standardized postoperative diet advancement protocol before progressing to the same dietary goals as the ILI-only group.
The primary outcome is %TBWL at week 12, calculated as (body weight at randomization - body weight at week 12) / body weight at randomization × 100%. The primary comparison will assess the difference in %TBWL between groups. Secondary outcomes include %TBWL at weeks 24 and 52; changes in BMI, body composition, fasting plasma glucose, HbA1c, insulin resistance indices, lipid profile, and quality of life measured with a validated questionnaire; and adherence to the assigned interventions. Body weight will be measured using a standardized protocol at baseline and scheduled follow-up visits.
Safety will be assessed in both groups throughout the 52-week follow-up. For participants undergoing ERCG, investigators will document technical completion, procedure and anesthesia-related events, and early and delayed complications, including bleeding, perforation, infection, persistent abdominal pain, nausea or vomiting, impaired oral intake, and events related to the clip-and-loop system. Safety assessments will include perioperative observation, early postoperative contacts, and evaluations at scheduled follow-up visits. All adverse events will be recorded with their onset, duration, severity, management, outcome, and assessed relationship to ERCG or study interventions. Endoscopy-related adverse events will be classified using the American Society for Gastrointestinal Endoscopy (ASGE) lexicon; serious adverse events and unplanned hospitalizations or reinterventions will be reported according to the study protocol.
Outcome assessors will be blinded to group assignment where feasible. The primary analysis will follow the intention-to-treat principle, with prespecified methods for handling missing outcome data.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 67 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo Endoscopic Radial Compression Gastroplasty (ERCG) with Intensive Lifestyle Intervention (ILI) after procedure.
Procedure: Endoscopic Radial Compression Gastroplasty (ERCG) · Behavioral: Intensive Lifestyle Intervention (ILI)
Patients in this group are arranged to receive intensive lifestyle intervention (ILI) comprising structured nutritional counseling, exercise prescription, and behavioral support.
Behavioral: Intensive Lifestyle Intervention (ILI)
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.
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.
Percentage of Total Body Weight Loss (%TBWL) at Week 12
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%.
Time frame: Weeks 12 after randomization
Percentage of Total Body Weight Loss (%TBWL) at Week 24 and 52
Percentage of total body weight loss (%TBWL) at Week 24 and 52 relative to randomization, calculated as \[(body weight at randomization- Week 24 or 52 body weight) / body weight at randomization\] × 100%.
Time frame: Weeks 24 and 52 after randomization
Body Mass Index (BMI) at Week 12, 24 and 52
Body mass index will be calculated as body weight in kilograms divided by the square of height in meters and reported in kg/m² at each specified follow-up visit.
Time frame: Weeks 12, 24, and 52 after randomization
Waist Circumference at Weeks 12, 24, and 52
Waist circumference will be measured in centimeters using a measuring tape around the abdomen at the level of the umbilicus at each specified follow-up visit.
Time frame: Weeks 12, 24, and 52 after randomization
Fasting Glucose, HbA1c and Lipid Panel at Week 12, 24 and 52
Fasting glucose measures the level of blood glucose on an empty stomach; the HbA1c test provides a measure of average blood sugar levels over a three-month period; lipid panel includes three measurements of cholesterol levels and a measurement of triglycerides.
Time frame: Weeks 12, 24, and 52 after randomization
Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score at Weeks 12, 24, and 52
Weight-related quality of life will be assessed using the 31-item Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. The total score will be calculated according to the instrument's scoring instructions and transformed to a scale ranging from 0 to 100, with higher scores indicating better weight-related quality of life.
Time frame: Weeks 12, 24, and 52 after randomization
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Affiliated Hospital to Academy of Military Medical Sciences