Weight Changes After Incretin-mimetics

February 20, 2026 updated by: Lisa Morselli, MD PhD, Medical College of Wisconsin
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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Roland James
  • Phone Number: 414-955-4992 414-955-6710
  • Email: rjames@mcw.edu

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: incretin mimetic discontinuation
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
Other: discontinuation of weight loss medication
Participants will be studied right before their injectable weight loss medication runs out, and 3 months later

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
weight change
Time Frame: 3 months
weight trajectories in the 3 months after treatment discontinuation
3 months
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 months
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.
3 months
body composition
Time Frame: 3 months
Body composition (fat mass, fat-free mass) will be measured at baseline and 3 months later by DXA
3 months
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".
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical College of Wisconsin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Wisconsin, Milwaukee

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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00052666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All datasets that pass quality control procedures and any other data that are deemed necessary to validate and replicate research findings will be shared.

IPD Sharing Time Frame

The data deposited will be made available to all investigators in the research community as soon as possible but no later than 12 months from the completion of the funding period or upon acceptance of the data for publication and release from journals, whichever is earlier. Requests for data will be filled in a timely manner, usually within 2 to 6 weeks of the request, depending on the chronological position of the request within the queue. In addition, research data which documents, supports, or validates the published research findings, will be made available (electronically or mailed hard-copies) upon request to NIH-funded research programs. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.

IPD Sharing Access Criteria

Other researchers will be able to access the IPD if they submit a proposal that describes planned analyses. A data sharing agreement must be signed. Researchers interested in the IPD can contact Dr. Morselli by email and send documents by email. Dr. Morselli will then share the ICR.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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