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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-18

Study Completion Date

2026-09-30

Brief Summary

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The study compares the effectiveness of treatment options for weight management after discontinuing semaglutide and tirzepatide. The primary outcome is absolute and percentage weight change at 12-weeks.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

WW Clinic

Intervention Type BEHAVIORAL

Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.

Bupropion-Naltrexone

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

WW Clinic

Intervention Type BEHAVIORAL

Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.

Bupropion-Naltrexone-Metformin

Intervention Type DRUG

Bupropion-Naltrexone-Metformin

WW Clinic - No medications

Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications.

Group Type EXPERIMENTAL

WW Clinic

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Bupropion-Naltrexone

Bupropion-Naltrexone

Intervention Type DRUG

Bupropion-Naltrexone-Metformin

Bupropion-Naltrexone-Metformin

Intervention Type DRUG

Eligibility Criteria

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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 \<22 kg/m2
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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WW International Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Jamil Alkhaddo

Medical Director, Clinical Development

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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GLP1 Transition Trial

Identifier Type: -

Identifier Source: org_study_id

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