Status:
RECRUITING
A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)
Lead Sponsor:
Michelle Cardel, PhD, MS, RD
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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-week...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT06605703
Start Date
September 18 2024
End Date
August 1 2025
Last Update
June 2 2025
Active Locations (1)
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1
WW International, Inc
New York, New York, United States, 10010