Comparing weight management treatments after stopping GLP-1 medications
The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: a Randomized Controlled Trial (GLP1 Transition Trial)
This study is testing different weight management treatments for people who have recently stopped using GLP-1 medications to see which one helps them lose weight best over 12 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | WW International Inc Industry-sponsored |
| Locations | 1 site (NYC, New York) |
| Trial ID | NCT06605703 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of various treatment options for weight management in individuals who have recently discontinued the use of GLP-1 medications such as semaglutide and tirzepatide. Participants will be randomized to receive one of three interventions: WW Clinic, Bupropion-Naltrexone, or Bupropion-Naltrexone-Metformin. The primary outcome will focus on measuring absolute and percentage weight change over a 12-week period. The study aims to provide insights into optimal weight management strategies following the cessation of these medications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of obesity or overweight and who have been on GLP-1 medications for at least six months.
Not a fit: Patients with a BMI below 26, diabetes, or those who have undergone surgical obesity treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients find effective alternatives for weight management after stopping GLP-1 medications.
How similar studies have performed: Other studies have explored weight management strategies after GLP-1 medication discontinuation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Previous hx of BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease) * Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months * At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound * Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason * Ability to provide informed consent prior to any trial-related activities * Able to read and write in English Exclusion Criteria: * BMI \<26 kg/m2 * Diabetes * Previous surgical obesity treatment * Currently pregnant or intending to become pregnant during the study * Not using highly effective contraception during the study period and for 3 months after * Breastfeeding * History of seizures or epilepsy * Current opioid use or in acute opioid withdrawal * Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs * History of glaucoma * Uncontrolled hypertension * Severe renal impairment and/or Chronic kidney disease stage III or GFR \<60 * Acute hepatitis or liver failure * Acute or chronic metabolic acidosis, including diabetic ketoacidosis * Use of antipsychotic medications or opiod analgesics * Current or previous history of anorexia or bulimia nervosa * Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight * Current SSRI, SNRI, mood stabilizer, amphetamine, or corticosteroid use * Current diagnosis of hyper or hypothyroidism or current use of thyroid replacement medicine * Current use of beta blockers * Current use of depo shot (medroxyprogesterone acetate) for birth control * Current diagnosis of Cushing's disease or syndrome * Current use of Monoamine Oxidase Inhibitors (MAOIs) * Known hypersensitivity to bupropion, naltrexone, or metformin * Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
Where this trial is running
NYC, New York
- WW International, Inc — Nyc, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Cardel, PhD, RD — WW International Inc
- Study coordinator: Rebecca A Jones, PhD
- Email: rebecca.jones@ww.com
- Phone: (800) 651-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.