Weight Changes After Incretin-mimetics

Medical College of Wisconsin

Status: Not yet enrolling

Conditions: Obesity and Obesity-related Medical Conditions

Treatments: Other: discontinuation of weight loss medication

Study type: Interventional

Funder types: Other

Identifiers

NCT06795360

PRO00052666

Details and patient eligibility

About

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?

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

incretin mimetic discontinuation

Experimental group

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. They will be studied right before their medication runs out, and 3 months later

Treatment:

Other: discontinuation of weight loss medication