Mayo clinic tests popular Weight-Loss drugs on stomach function
NCT ID NCT06801015
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study at Mayo Clinic compares two FDA-approved weight-loss drugs, semaglutide and tirzepatide, against a placebo to see how they affect stomach emptying and feelings of fullness. Thirty adults with obesity or overweight plus prediabetes will receive weekly injections for 24 weeks. Researchers will measure stomach function using special imaging and calorie intake tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Semaglutide and tirzepatide (weekly injections)
- What this could lead to
- If successful, this could help doctors understand how these weight-loss drugs work on the stomach, potentially improving treatment for obesity.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to everyone. The drugs are already approved, but this trial focuses on stomach function, not weight loss directly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
PLEASE NOTE: Potential participants must reside within 50 miles of Mayo Clinic for 7 consecutive months due to non-mobile GI imaging cameras. Inclusion criteria: * Adults (18-75 years) who have BMI \>30 or \>27kg/m2 who also have prediabetes or T2DM on diet treatment only * Able to reside within 50 miles of Mayo Clinic for the duration of the study * Not currently on treatment (exceptions below) for cardiac, pulmonary, GI, hepatic, renal, hematological, neurological, or endocrine disorders. * Biological sex: men or women. We shall attempt to recruit equal proportions of men and women. Women of childbearing potential will be using an effective form of contraception and have negative pregnancy tests within 48 hours of enrollment and before each isotope-based radiation exposure as part of the tests for gastric emptying. In addition, monthly urine pregnancy tests will be performed in females with childbearing potential. Exclusion criteria: * Weight exceeding 137kg (safety limit of camera for measuring gastric volumes) * Abdominal surgery other than appendectomy, Caesarian section or tubal ligation, cholecystectomy * Chronic GI diseases, systemic disease or medications that could affect GI motility, appetite or absorption * Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia II * Patients with T2DM on GLP-1RAs, amylin agonists/analogs (e.g. pramlintide), insulin, sulfonylureas (all due to risk of hypoglycemia with semaglutide or tirzepatide treatment); or on metformin, acarbose or DPP-4 inhibitors (e.g. sitagliptin and vildagliptin). * Past or current history of pancreatitis, gallstones, history of alcoholism, blood triglyceride levels \> 500mg/dL * Significant untreated psychiatric dysfunction or an active eating disorder (Clark et al 2007, Cunningham et al 2012) based on screening with the Hospital Anxiety and Depression Inventory \[HAD (Zigmond \& Snaith 1983)\], a self-administered alcoholism screening test \[AUDIT-C (Bush et al 1998)\], and the Questionnaire on Eating and Weight Patterns-Revised \[binge eating disorders and bulimia (Yanovski et al 2015)\]. If such a dysfunction is identified by a HAD score \>11 on either the anxiety or depression subscales or difficulties with substance or eating disorders, the participant will be interviewed by a study investigator and, if excluded, will be given a referral letter to his/her primary care doctor for further appraisal and follow-up treatment. * Intake of any medication (except multivitamins) within 7 days of the study. Exceptions are birth control pill, estrogen and thyroxine replacement, and medication administered for co-morbidities as long as they do not alter gastric functions. Thus, statins for hyperlipidemia, diuretics, β-adrenergic blockers, ACE inhibitors and angiotensin antagonists for hypertension are permissible. In contrast, resin sequestrants for hyperlipidemia (Psichas et al 2012), α2-adrenergic agonists for hypertension, are not permissible due to effects on stomach or appetite. * Documented delayed gastric emptying: gastric emptying T1/2 \>174 min or gastric retention at 4 hours \>25% based on 5-95%ile of 319 controls' GES of the same meal (320kcal, 30% fat) (Camilleri et al 2012a, Table 1) * Hypersensitivity to semaglutide or tirzepatide * Participate in highly intense physical activity program that could potentially interfere with study interpretation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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