Weight Changes After Incretin-mimetics

Not Applicable

Not yet recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06795360
• Lead Sponsor: Medical College of Wisconsin

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?

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Study Start: 2025-12-01
• Primary Completion: 2030-11-30
• Study Completion: 2030-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
weight change	3 months	weight trajectories in the 3 months after treatment discontinuation
fasting and post-prandial circulating AgRP	3 months	Circulating AgRP will be measured after an overnight fast and during a 3-hour mixed meal test, at baseline (while still on injectable weight loss drug) and 3 months later. The mixed meal will consist in a nutrtional shake consumed in 5 min.

Secondary Outcome Measures

Name	Time	Method
subjective hunger ratings	3 months	Participants will be asked to rate current hunger with a visual analogue scale in fasting conditions and hourly during a 3-hour mixed meal test. This will be done at baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation. Scores go from 0 to 100, with 0 indicating "Not hungry at all" and 100 indicating "Extremely hungry".
resting metabolic rate (RMR)	3 months	RMR will be measured in fasting conditions at baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation.
RMR adaptation	3 months	RMR adaptation will be estimated baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation. RMR adaptation will be defined as the difference between measured and predicted RMR. Predicted RMR will be computed with a linear regression equation obtained from baseline data from the whole cohort.
body composition	3 months	Body composition (fat mass, fat-free mass) will be measured at baseline and 3 months later by DXA