Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06795360

Weight Changes After Incretin-mimetics

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?

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

discontinuation of weight loss medication

Other

Participants will be studied right before their injectable weight loss medication runs out, and 3 months later

Primary outcomes

  1. weight change

    Time frame: 3 months

    weight trajectories in the 3 months after treatment discontinuation

  2. fasting and post-prandial circulating AgRP

    Time frame: 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 outcomes

  1. subjective hunger ratings

    Time frame: 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".

  2. resting metabolic rate (RMR)

    Time frame: 3 months

    RMR will be measured in fasting conditions at baseline (while still on injectable weight loss drug) and 3 months after treatment discontinuation.

  3. RMR adaptation

    Time frame: 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.

  4. body composition

    Time frame: 3 months

    Body composition (fat mass, fat-free mass) will be measured at baseline and 3 months later by DXA

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa L Morselli, MD PhD

CONTACT

[email protected]

414-955-6710

Roland James

CONTACT

[email protected]

414-955-6710 ext. 414-955-4992

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • University of Wisconsin, Milwaukee

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jan 28, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.