A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)
The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: A Randomized Controlled Trial (GLP1 Transition Trial)
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2024
CompletedStudy Start
First participant enrolled
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
September 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2026
CompletedApril 13, 2026
January 1, 2026
1.4 years
September 18, 2024
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent body weight change at 12 weeks
Measurement of weight using a bluetooth body weight scale
Baseline, 12 weeks
Secondary Outcomes (10)
Change in body weight (in kg or pounds) at 12 weeks
Baseline, 12 weeks
Physical Activity and Sedentary Behavior
Baseline, 12 weeks
Dietary Intake
Baseline, 12 weeks
Habit/Automaticity
Baseline, 12 weeks
Hunger VAS (Visual Analogue Scale)
Baseline, 12 weeks
- +5 more secondary outcomes
Study Arms (3)
WW Clinic - No medications
EXPERIMENTALParticipants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications.
WW Clinic + Meds v1
EXPERIMENTALParticipants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
WW Clinic + Meds v2
EXPERIMENTALParticipants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.
Interventions
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WW International, Inc
New York, New York, 10011, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kara Marlatt, PhD, MPH
WW International Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sr Director, Scientific Research
Study Record Dates
First Submitted
September 18, 2024
First Posted
September 20, 2024
Study Start
September 18, 2024
Primary Completion
February 5, 2026
Study Completion
February 5, 2026
Last Updated
April 13, 2026
Record last verified: 2026-01