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

Lilly

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Acetaminophen; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04407234

I8F-MC-GPHU (Other Identifier)

17376

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Key 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Tirzepatide + Acetaminophen

Experimental group

Description:

Participants received 5mg tirzepatide on Day 1 and Day 8; 10 mg tirzepatide on Day 15, 22 and 29; 15 mg tirzepatide on Day 36 administered subcutaneously (SC) and 160 mg acetaminophen administered orally on Day -1, Day 2 and Day 37.

Treatment:

Drug: Tirzepatide

Drug: Acetaminophen