RECRUITING

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

Talk to us

Conditions

ObesityOverweight

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-09-18
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06605703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * 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)
  3. * Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months
  4. * At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound
  5. * Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason
  6. * Ability to provide informed consent prior to any trial-related activities
  7. * Able to read and write in English
  1. * BMI \<26 kg/m2
  2. * Diabetes
  3. * Previous surgical obesity treatment
  4. * Currently pregnant or intending to become pregnant during the study
  5. * Not using highly effective contraception during the study period and for 3 months after
  6. * Breastfeeding
  7. * History of seizures or epilepsy
  8. * Current opioid use or in acute opioid withdrawal
  9. * Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs
  10. * History of glaucoma
  11. * Uncontrolled hypertension
  12. * Severe renal impairment and/or Chronic kidney disease stage III or GFR \<60
  13. * Acute hepatitis or liver failure
  14. * Acute or chronic metabolic acidosis, including diabetic ketoacidosis
  15. * Use of antipsychotic medications or opiod analgesics
  16. * Current or previous history of anorexia or bulimia nervosa
  17. * Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
  18. * Current SSRI, SNRI, mood stabilizer, amphetamine, or corticosteroid use
  19. * Current diagnosis of hyper or hypothyroidism or current use of thyroid replacement medicine
  20. * Current use of beta blockers
  21. * Current use of depo shot (medroxyprogesterone acetate) for birth control
  22. * Current diagnosis of Cushing's disease or syndrome
  23. * Current use of Monoamine Oxidase Inhibitors (MAOIs)
  24. * Known hypersensitivity to bupropion, naltrexone, or metformin
  25. * Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator

Contacts and Locations

Study Contact

Rebecca A Jones, PhD
CONTACT
(800) 651-6000
rebecca.jones@ww.com

Principal Investigator

Michelle Cardel, PhD, RD
PRINCIPAL_INVESTIGATOR
WW International Inc
Rebecca Jones, PhD
PRINCIPAL_INVESTIGATOR
WW International Inc

Study Locations (Sites)

WW International, Inc
NYC, New York, 10010
United States

Collaborators and Investigators

Sponsor: Michelle Cardel, PhD, MS, RD

  • Michelle Cardel, PhD, RD, PRINCIPAL_INVESTIGATOR, WW International Inc
  • Rebecca Jones, PhD, PRINCIPAL_INVESTIGATOR, WW International Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Overweight