ACTIVE_NOT_RECRUITING

A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: A Randomized Controlled Trial (GLP1 Transition Trial)

Quick Facts

Study Start:2024-09-18

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06605703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Jamil Alkhaddo, MD

PRINCIPAL_INVESTIGATOR

WW International Inc

Study Locations (Sites)

WW International, Inc

New York, New York, 10011

United States

Collaborators and Investigators

Sponsor: WW International Inc

Jamil Alkhaddo, MD, PRINCIPAL_INVESTIGATOR, WW International Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-09-18

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Obesity
Overweight