GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4

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)

Lead sponsor

WW International Inc

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

226

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06605703

Org study IDGLP1 Transition Trial

Timeline

Milestones

Study start2024-09-18actual

Study first posted2024-09-20actual

Primary completion2026-02-05actual

Study completion2026-02-05actual

Last update posted2026-04-13actual

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Weight & body composition

Other clinical outcomes

Other (unclassified)

Weight & body composition

2 endpoints

Primary/protocol endpoint

Percent body weight change at 12 weeks

Time frame:Baseline, 12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (in kg or pounds) at 12 weeks

Time frame:Baseline, 12 weeks

Body weight, absolute change (kg)