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NCT06795360 | NOT YET RECRUITING | Obesity and Obesity-related Medical Conditions


Weight Changes After Incretin-mimetics
Sponsor:

Medical College of Wisconsin

Information provided by (Responsible Party):

Lisa Morselli, MD Phd

Brief Summary:

The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?

Condition or disease

Obesity and Obesity-related Medical Conditions

Intervention/treatment

discontinuation of weight loss medication

Phase

NA

Detailed Description:

This study will enroll people who are taking an injectable weight loss drug, have lost weight with the help of this drug, and are required by their health insurance plan to discontinue treatment. Participants will first be screened for health conditions that would prevent them from entering the study. Once enrolled, participants will be asked to have the following testing while still on the injectable weight loss drug: body weight measurement, body composition (fat and lean mass), resting energy expenditure (calories burned), multiple blood draws after overnight fast and after drinking and nutritional shake urine collection, urine collection, measurement of heart rate, measurement of physical activity and sleep, questionnaires. Participants will then stop taking the injectable weight loss drug when the prescription runs out, and the same tests will be repeated 3 months later.

Study Type : INTERVENTIONAL
Estimated Enrollment : 52 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Weight Changes After Incretin-mimetics
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2030-11-30
Estimated Study Completion Date : 2030-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * adults 18 years or older
  • * men and women
  • * prescribed an incretin-mimetic for weight loss and for whom insurance coverage for this specific drug will lapse
  • * any ethnicity
Exclusion Criteria
  • * weight \> or = 400 lb
  • * type 1 or type 2 diabetes
  • * patients taking steroid medications
  • * anemia
  • * heart disease
  • * advanced kidney disease (CKD stage 4 and 5)
  • * decompensated liver disease
  • * hyperthyroidism
  • * untreated hypothyroidism
  • * active cancer
  • * post solid organ or bone marrow transplant
  • * HIV/AIDS
  • * pregnancy/plan for pregnancy in the next 6 months
  • * breastfeeding
  • * post-menopausal women
  • * current smoker
  • * current recreational drug use
  • * night shift or rotating shift workers

Weight Changes After Incretin-mimetics

Location Details

NCT06795360


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