Clinical trial

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

Name

17376

Description

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.

Trial arms

Trial start

2020-09-15

Estimated PCD

2021-01-07

Trial end

2021-01-07

Status

Completed

Phase

Early phase I

Treatment

Tirzepatide

Tirzepatide administered SC.

Arms:

Tirzepatide + Acetaminophen

Other names:

LY3298176

Acetaminophen

Acetaminophen administered orally.

Arms:

Tirzepatide + Acetaminophen

Size

Primary endpoint

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen

Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

Updated at

2024-01-08

1 organization

2 products

3 indications

Organization

Eli Lilly and Company

Product

Indication

Indication

Indication

Product