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Clinical Trial NCT06801015 for Obesity is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Mayo ClinicEffects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions Phase 4 30
Clinical Trial NCT06801015 is designed to study Treatment for Obesity. It is a Phase 4 interventional study that is active, not recruiting, having started on October 1, 2025, with plans to enroll 30 participants. Led by Mayo Clinic, it is expected to complete by March 31, 2028. The latest data from ClinicalTrials.gov was last updated on December 26, 2025.
Brief Summary
The purpose of this study is to compare effects of weekly SQ semaglutide 2.4mg SQ, SQ tirzepatide 10mg, and placebo administered for 24 weeks on GES measured repeatedly at baseline, 16 weeks, 24 weeks, 28 weeks, 4 weeks after stopping the medication, and accommodation and satiation at 24 weeks compared to baseline.
Official Title
A Randomized, Placebo-Controlled Trial of the Effects of Long-Acting GLP-1 or Dual Incretin (GLP-1 and GIP) Modulation on Gastric Motor Functions
Conditions
ObesityOther Study IDs
- 24-011786
NCT ID Number
Start Date (Actual)
2025-10-01
Last Update Posted
2025-12-26
Completion Date (Estimated)
2028-03-31
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 4
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalsemaglutide Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment | Semaglutide Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week |
ExperimentalTirzepatide Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment | Tirzepatide Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week |
Placebo Comparatorplacebo Administered by subcutaneous injection once per week | Placebo Placebo administered by subcutaneous injection once per week. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach | Gastric emptying of an egg meal measured by scintigraphy | Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks) |
Body weight | Measurement of body weight using weight scales | Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Calories to fullness, kilocalories (kcal) | Measurement of kilocalorie intake at comfortable fullness based on Ensure liquid nutrient | Measurement at baseline, and after 24 weeks' treatment |
Maximum tolerated calories, kilocalories (kcal) | Measurement of kilocalorie intake at maximal fullness based on Ensure liquid nutrient | Measurement at baseline, and after 24 weeks' treatment |
Fasting gastric volume, milliliters (mL) | Measurement of gastric volume during fasting using 99mTc-SPECT (single photon emission computed tomography) imaging | Measurement at baseline, and after 24 weeks' treatment |
Gastric accommodation vol (postprandial minus fasting volume), milliliters (mL) | Measurement of gastric volume following 300 mL of Ensure using 99mTc-SPECT (single photon emission computed tomography) imaging | Measurement at baseline, and after 24 weeks' treatment |
Peak postprandial GLP-1 (glucagon-like peptide-1) pmol/L | GLP-1 measured fasting, and 15, 45, and 90 minutes postprandially | Measurement at baseline, and after 24 weeks' treatment |
Peak postprandial peptide tyrosine tyrosine (PYY) pmol/L | PYY measured fasting, and 15, 45, and 90 minutes postprandially | Measurement at baseline, and after 24 weeks' treatment |
DEXA (dual energy X-ray absorptiometry) body composition | Body composition (including total body fat) by dual-energy X-ray absorptiometry (DEXA) technology | Measurement at baseline, and after 24 weeks' treatment |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
Mayo Clinic861 active studies to exploreStudy Responsible Party
Michael Camilleri, MD, Principal Investigator, Principal Investigator, Mayo Clinic
No contact data.
1 Study Locations in 1 Countries
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States