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

Michelle Cardel, PhD, MS, RD

Status and phase: Enrolling; Phase 4

Conditions: Overweight; Obesity

Treatments: Behavioral: WW Clinic; Drug: Bupropion-Naltrexone-Metformin; Drug: Bupropion-Naltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06605703

GLP1 Transition Trial

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 3 patient groups

WW Clinic - No medications

Experimental group

Description:

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

Treatment:

Behavioral: WW Clinic

WW Clinic + Meds v1

Experimental group

Description:

Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.

Treatment:

Drug: Bupropion-Naltrexone

Behavioral: WW Clinic

WW Clinic + Meds v2

Experimental group

Description:

Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.

Treatment:

Drug: Bupropion-Naltrexone-Metformin

Behavioral: WW Clinic