Clinical trial NCT06605703: A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Overweight
Lead sponsor: WW International Inc
Sponsor class: INDUSTRY
First posted: 2024-09-20
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-weeks.


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

Primary outcomes:
measure: Percent body weight change at 12 weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in body weight (in kg or pounds) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Physical Activity and Sedentary Behavior
timeFrame: Baseline, 12 weeks
measure: Dietary Intake
timeFrame: Baseline, 12 weeks
measure: Habit/Automaticity
timeFrame: Baseline, 12 weeks
measure: Hunger VAS (Visual Analogue Scale)
timeFrame: Baseline, 12 weeks
measure: Impact on Quality of Life
timeFrame: Baseline, 12 weeks
measure: Well-being
timeFrame: Baseline, 12 weeks
measure: Body Appreciation
timeFrame: Baseline, 12 weeks
measure: Self-Compassion
timeFrame: Baseline, 12 weeks
measure: Weight Bias
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: NYC
country: United States
facility: WW International, Inc
state: New York
Study officials:
affiliation: WW International Inc
name: Michelle Cardel, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: