A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)
NCT ID: NCT06605703
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
226 participants
INTERVENTIONAL
2024-09-18
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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WW Clinic + Meds v1
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
WW Clinic
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Bupropion-Naltrexone
Bupropion-Naltrexone
WW Clinic + Meds v2
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
WW Clinic
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Bupropion-Naltrexone-Metformin
Bupropion-Naltrexone-Metformin
WW Clinic - No medications
Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications.
WW Clinic
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Interventions
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WW Clinic
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Bupropion-Naltrexone
Bupropion-Naltrexone
Bupropion-Naltrexone-Metformin
Bupropion-Naltrexone-Metformin
Eligibility Criteria
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Inclusion Criteria
* 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
* Diabetes
* Previous surgical obesity treatment
* Currently pregnant or intending to become pregnant during the study
* 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
18 Years
ALL
No
Sponsors
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WW International Inc
INDUSTRY
Responsible Party
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Jamil Alkhaddo
Medical Director, Clinical Development
Principal Investigators
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Jamil Alkhaddo, MD
Role: PRINCIPAL_INVESTIGATOR
WW International Inc
Locations
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WW International, Inc
New York, New York, United States
Countries
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Other Identifiers
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GLP1 Transition Trial
Identifier Type: -
Identifier Source: org_study_id
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