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

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.

Conditions

Obesity, Overweight

Study Overview

Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

NYC

WW International, Inc, NYC, New York, United States, 10010

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \<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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Michelle Cardel, PhD, MS, RD,

Michelle Cardel, PhD, RD, PRINCIPAL_INVESTIGATOR, WW International Inc

Rebecca Jones, PhD, PRINCIPAL_INVESTIGATOR, WW International Inc

Study Record Dates

2025-08