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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Overweight; Obesity
• Interventions: Drug: Tirzepatide; Drug: Acetaminophen

• Registration Number: NCT04407234
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Study Start: 2020-09-15
• Primary Completion: 2021-01-07
• Study Completion: 2021-01-07
• Results First Submitted: 2022-06-07
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Results First Posted: 2024-01-08
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tirzepatide + Acetaminophen	Tirzepatide	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.
Tirzepatide + Acetaminophen	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
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	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
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	Maximum Observed Drug Concentration (cmax) of Acetaminophen

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) Data by Diabetic Status	Predose on Day 29 and follow-up (Day 64)	Levels of Hemoglobin A1c (HbA1c) were assessed at predose on Day 29, and at follow-up (Day 64).
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 at Steady State For Non-diabetic	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	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 at Steady State For Non-diabetic
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM	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	Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration \[ AUC(0-tlast)\] of Acetaminophen at Steady State For T2DM
PK: Cmax of Acetaminophen at Steady State Non-diabetic	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: Cmax of Acetaminophen at Steady State Non-diabetic
PK: Cmax of Acetaminophen at Steady State For T2DM	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: Cmax of Acetaminophen at Steady State T2DM

Trial Locations

Locations (1)

Clinical Pharmacology of Miami; 🇺🇸 Hialeah, Florida, United States