ObesityPhase 4NCT06801015
Effects 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
A Phase 4 study testing Semaglutide and Tirzepatide in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Mar 2028
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
- Conditions
- Obesity
- Being tested
- Semaglutide, Tirzepatide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week
TirzepatideDrug
Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week
PlaceboDrug
Placebo administered by subcutaneous injection once per week.
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Experimental | Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment Receives: Drug: Semaglutide |
| Tirzepatide | Experimental | Administered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment Receives: Drug: Tirzepatide |
| placebo | Placebo comparator | Administered by subcutaneous injection once per week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)
Secondary outcomes (7)
Calories to fullness, kilocalories (kcal)
Measurement of kilocalorie intake at comfortable fullness based on Ensure liquid nutrient
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Measurement at baseline, and after 24 weeks' treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Oct 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of the effects of semaglutide, tirzepatide, and placebo with concealed allocation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801015
- Sponsor's protocol ID
- 24-011786
- Status last verified
- Dec 2025
- First submitted
- 24 Jan 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06801015
- Acronym / sponsor ID
- 24-011786
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial of the effects of semaglutide, tirzepatide, and placebo with concealed allocation
| Arm | Type | Receives |
|---|---|---|
| semaglutide | Experimental | Drug: SemaglutideAdministered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment |
| Tirzepatide | Experimental | Drug: TirzepatideAdministered by subcutaneous injection once per week in accordance with FDA approved escalation as well as maintenance treatment |
| placebo | Placebo comparator | Drug: PlaceboAdministered by subcutaneous injection once per week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
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 |
|---|---|---|
| SemaglutideBoth interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week | Drug | semaglutide |
| TirzepatideBoth interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week | Drug | Tirzepatide |
| PlaceboPlacebo administered by subcutaneous injection once per week. | Drug | placebo |
Primary outcome
Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach
Time frame: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)
Gastric emptying of an egg meal measured by scintigraphy
Body weight
Time frame: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)
Measurement of body weight using weight scales
7 secondary outcomes
Calories to fullness, kilocalories (kcal)
Time frame: Measurement at baseline, and after 24 weeks' treatment
Maximum tolerated calories, kilocalories (kcal)
Time frame: Measurement at baseline, and after 24 weeks' treatment
Fasting gastric volume, milliliters (mL)
Time frame: Measurement at baseline, and after 24 weeks' treatment
Gastric accommodation vol (postprandial minus fasting volume), milliliters (mL)
Time frame: Measurement at baseline, and after 24 weeks' treatment
Peak postprandial GLP-1 (glucagon-like peptide-1) pmol/L
Time frame: Measurement at baseline, and after 24 weeks' treatment
Peak postprandial peptide tyrosine tyrosine (PYY) pmol/L
Time frame: Measurement at baseline, and after 24 weeks' treatment
DEXA (dual energy X-ray absorptiometry) body composition
Time frame: Measurement at baseline, and after 24 weeks' treatment
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 26 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Camilleri principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide and Tirzepatide in people with Obesity, run by Mayo Clinic at 1 site in United States.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying of solids T1/2 min, that is time for half meal to empty from stomach (time frame: Measurement at baseline, after 16 and 24 weeks' treatment, and at 28 weeks (off treatment for 4 weeks)). 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 26 Dec 2025.