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

Primary Purpose

Overweight, Obesity, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tirzepatide
Acetaminophen
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Clinical Pharmacology of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tirzepatide + Acetaminophen

Arm Description

Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Time of Maximum Concentration (Tmax) of Acetaminophen
PK: Tmax of Acetaminophen
PK: Tmax of Acetaminophen
PK: Tmax of Acetaminophen
PK: Tmax of Acetaminophen
PK: Tmax of Acetaminophen

Secondary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in HbA1c
PK: AUC(0-tlast) of Tirzepatide at Steady State
PK: AUC(0-tlast) of Tirzepatide at Steady State
PK: Cmax of Tirzepatide at Steady State
PK: Cmax of Tirzepatide at Steady State

Full Information

First Posted
May 27, 2020
Last Updated
January 18, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04407234
Brief Title
A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Official Title
The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
January 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide + Acetaminophen
Arm Type
Experimental
Arm Description
Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Tirzepatide administered SC.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen administered orally.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Time of Maximum Concentration (Tmax) of Acetaminophen
Description
PK: Tmax of Acetaminophen
Time Frame
Pre-dose through 36 hours post-dose on Day-1
Title
PK: Tmax of Acetaminophen
Description
PK: Tmax of Acetaminophen
Time Frame
Pre-dose through 36 hours post-dose on Day 2
Title
PK: Tmax of Acetaminophen
Description
PK: Tmax of Acetaminophen
Time Frame
Pre-dose through 36 hours post-dose on Day 37
Secondary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Description
Change from Baseline in HbA1c
Time Frame
Pre-dose through 9 weeks
Title
PK: AUC(0-tlast) of Tirzepatide at Steady State
Description
PK: AUC(0-tlast) of Tirzepatide at Steady State
Time Frame
Pre-dose through 9 weeks
Title
PK: Cmax of Tirzepatide at Steady State
Description
PK: Cmax of Tirzepatide at Steady State
Time Frame
Pre-dose through 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Pharmacology of Miami
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/2VTN9N9xaJ4FhSAZuwJdif?conditionId=1wecF0AgauDdWnqHV7GJGP
Description
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A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

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