Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension.
John P H Wilding, Rachel L Batterham, Melanie Davies...
https://pubmed.ncbi.nlm.nih.gov/35441470/Actively Recruiting
Led by Dr. Christopher McGowan · Updated on 2025-03-21
20
Participants Needed
2
Research Sites
N/A
Total Duration
This research investigates the effects of gastric fundal mucosal ablation GFMA on weight changes in adults with obesity who have previously lost more than 10% of their body weight using GLP-1 medications like semaglutide or tirzepatide and are planning to stop these medications. Obesity is a complex and ongoing condition affecting many people, and while incretin mimetics help with weight loss and related health issues, their benefits tend to fade when the medication is stopped. This study aims to explore whether GFMA can help maintain weight loss after stopping these drugs. Participants will undergo a single endoscopic procedure called GFMA, which uses hybrid argon plasma coagulation to treat the lining of the stomachs fundus. This treatment is designed to reduce hunger by lowering levels of the hunger hormone ghrelin and making the stomach less stretchy, helping control appetite. The procedure will be done after participants have discontinued their GLP-1 therapy. During the study, researchers will monitor participants weight changes over 12 months, focusing on the percentage of total body weight lost from the start. They will also assess quality of life, hunger and appetite levels, eating behavior, and any adverse events at multiple points throughout the year. Participants will have regular evaluations to track body mass index, weight recurrence, and their confidence in managing eating and weight.
CONDITIONS
MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
S
Shannon Casey, MS
C
Chase Wooley, BS
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Dr. Christopher McGowan
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | GFMA after GLP-1 Discontinuation | Current Care: Restart GLP-1 Agonists |
|---|---|---|
| What it is | Endoscopic procedure ablating the gastric fundus lining (GFMA) performed after discontinuation of GLP-1 agonist therapy in adults with obesity who previously lost ≥10% body weight on GLP-1s. | Restarting GLP-1 receptor agonist therapy (such as semaglutide or tirzepatide) after previous discontinuation for continued weight management in patients with obesity. |
| Primary use or intent | Aims to maintain weight loss following GLP-1 discontinuation by using endoscopic ablation to alter gastric physiology and support weight management. | Used as guideline-recommended pharmacological therapy to continue or restart GLP-1 agonists for sustaining weight loss and minimizing weight regain. |
| Important limitations | GFMA is investigational in humans, with safety, efficacy, and long-term outcomes not yet established beyond early experimental evidence. The current study is limited in size and lacks a comparator arm. | GLP-1 agonist therapy is associated with weight regain after discontinuation; long-term adherence is necessary and some patients may experience cardiometabolic rebound effects. Not all patients tolerate GLP-1s or have access due to cost or supply. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants undergo a single endoscopic session for Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy.
1 visit (in-person)
Duration - 12 months
Participants are monitored for weight loss, adverse events, quality of life, appetite, and other health assessments for up to 12 months following the procedure.
Visits at Month 1, 2, 3, 6, 7, 8, 9, 10, 11, and 12
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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John P H Wilding, Rachel L Batterham, Melanie Davies...
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https://pubmed.ncbi.nlm.nih.gov/29476845/Mihaela-Simona Popoviciu, Lorena Păduraru, Galal Yahya...
https://pubmed.ncbi.nlm.nih.gov/37445623/Dr. Christopher McGowan
Lead Sponsor