ClinicalTrials.gg
Not yet recruitingNCT06795360Updated Feb 24, 2026

Weight Changes After Incretin-mimetics

An interventional study of discontinuation of weight loss medication in Obesity and Obesity-related Medical Conditions, sponsored by Medical College of Wisconsin. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Obesity and Obesity-related Medical Conditions

Keywords

  • obesity
  • weight loss
  • weight gain
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 52 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 548 studies on the registry; 122 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 57 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • weight > or = 400 lb
  • type 1 or type 2 diabetes
  • patients taking 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
  • /AIDS
  • pregnancy/plan for pregnancy in the next 6 months
  • breastfeeding
  • women
  • current smoker
  • current recreational drug use
  • night shift or rotating shift workers
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • 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

Interventions

  • Otherdiscontinuation of weight loss medication

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

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What researchers measure

Primary outcomes

  1. weight change

    weight trajectories in the 3 months after treatment discontinuation

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

Secondary outcomes

  1. subjective hunger ratings

    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".

    Time frame: 3 months

  2. resting metabolic rate (RMR)

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

    Time frame: 3 months

  3. RMR adaptation

    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.

    Time frame: 3 months

  4. body composition

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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

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

Supporting information: Study protocol, Clinical study report

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Nov 2031, 59 months later.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 59 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2025
First posted
Jan 28, 2025
StartEst.
Dec 1, 2026
Primary completionEst.
Nov 30, 2031
CompletionEst.
Nov 30, 2031
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06795360
Collaborators
University of Wisconsin, Milwaukee
Responsible party
Lisa Morselli, MD PhD (Assistant Professor, Medical College of Wisconsin) — Principal investigator
First posted
Jan 28, 2025
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2031 (estimated)
Completion
Nov 30, 2031 (estimated)
Last update
Feb 24, 2026

Study contacts

Roland James
Contact
rjames@mcw.edu
414-955-6710 ext. 414-955-4992
Lisa L Morselli, MD PhD
Contact
lmorselli@mcw.edu
414-955-6710

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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