NCT06795360

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?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
61mo left

Started Dec 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2031

Last Updated

February 24, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 22, 2025

Last Update Submit

February 20, 2026

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

obesityweight lossweight gain

Outcome Measures

Primary Outcomes (2)

  • weight change

    weight trajectories in the 3 months after treatment discontinuation

    3 months

  • fasting and post-prandial circulating AgRP

    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 Outcomes (4)

  • subjective hunger ratings

    3 months

  • resting metabolic rate (RMR)

    3 months

  • RMR adaptation

    3 months

  • body composition

    3 months

Study Arms (1)

incretin mimetic discontinuation

EXPERIMENTAL

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

Interventions

discontinuation of weight loss medicationOTHER

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

incretin mimetic discontinuation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight LossWeight Gain

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Central Study Contacts

Roland James

CONTACT

414-955-6710rjames@mcw.edu

Lisa L Morselli, MD PhD

CONTACT

414-955-6710lmorselli@mcw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

November 30, 2031

Study Completion (Estimated)

November 30, 2031

Last Updated

February 24, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
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.
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.