Obesity and Obesity-related Medical ConditionsNCT06795360
Weight Changes After Incretin-mimetics
A study testing discontinuation of weight loss medication in people with Obesity and Obesity-related Medical Conditions, run by Medical College of Wisconsin.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- discontinuation of weight loss medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- discontinuation of weight loss medication
- Keywords
- obesity, weight loss, weight gain
- Medical subject headings
- Obesity, Weight Loss, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discontinuation of weight loss medicationOther
Participants will be studied right before their injectable weight loss medication runs out, and 3 months later
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: discontinuation of weight loss medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
weight trajectories in the 3 months after treatment discontinuation
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
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".
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
body composition
Body composition (fat mass, fat-free mass) will be measured at baseline and 3 months later by DXA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Responsible party
- Principal investigator, Lisa Morselli, MD PhD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795360
- Sponsor's protocol ID
- PRO00052666
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Changes After Incretin-mimetics
- ClinicalTrials.gov ID
- NCT06795360
- Acronym / sponsor ID
- PRO00052666
- Keywords
- obesity, weight loss, weight gain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of Wisconsin, Milwaukee
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| incretin mimetic discontinuation | Experimental | Other: discontinuation of weight loss medicationThis 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- weight > or = 400 lb
- type 1 or type 2 diabetes
- patients taking steroid medications
- anemia
- heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| discontinuation of weight loss medicationParticipants will be studied right before their injectable weight loss medication runs out, and 3 months later | Other | incretin mimetic discontinuation |
Primary outcome
weight change
Time frame: 3 months
weight trajectories in the 3 months after treatment discontinuation
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.
4 secondary outcomes
subjective hunger ratings
Time frame: 3 months
resting metabolic rate (RMR)
Time frame: 3 months
RMR adaptation
Time frame: 3 months
body composition
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing discontinuation of weight loss medication in people with Obesity and Obesity-related Medical Conditions, run by Medical College of Wisconsin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland James (414-955-6710 ext. 414-955-4992, rjames@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.