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

Launched by MICHELLE CARDEL, PHD, MS, RD · Sep 18, 2024

Keywords

ClinConnect Summary

The GLP1 Transition Trial is a study designed to find out the best ways to manage weight for people who have stopped taking certain medications (semaglutide or tirzepatide) used for obesity or overweight. The main goal of the trial is to see how much weight participants lose over 12 weeks after stopping these medications. This trial is currently looking for volunteers who are at least 18 years old and have a history of being overweight or obese, as shown by their body mass index (BMI). Participants should also have been taking medications like Wegovy, Ozempic, Mounjaro, or Zepbound for at least six months and have lost at least 15% of their body weight during that time.

If you decide to join the trial, you will stop taking your current GLP-1 medication and explore different weight management options to see which works best for you. It’s important to note that not everyone can participate; there are specific health conditions and situations that would exclude someone from the study, such as having diabetes or certain ongoing health issues. If you’re interested and think you might qualify, you’ll need to provide consent and be able to communicate in English. This study aims to help improve weight management strategies for those who are no longer using these medications.

Gender

ALL

Eligibility criteria

• 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