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A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide | Clinical Trials | Clareo Health

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A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

NCT04407234•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
•For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
•For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
•Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion Criteria

•Have undergone gastric bypass or bariatric surgery
•Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
•For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
•Have any lifetime history of a suicide attempt
•Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
•Unwilling to comply with smoking and alcohol restrictions during the study

Locations (1)

Clinical Pharmacology of Miami

Hialeah, Florida, United States

Key Dates

Start Date

September 15, 2020

Primary Completion Date

January 7, 2021

Completion Date

January 7, 2021

Last Updated

January 8, 2024

Enrollment

ACTUAL participants

Conditions

OverweightObesityDiabetes Mellitus, Type 2

Interventions

Tirzepatide

DRUG

Acetaminophen

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

Inclusion Criteria

Exclusion Criteria

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