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A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3437943
Midazolam
Warfarin
Caffeine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Overweight, Obesity, Drug Interaction, Cocktail, Pharmacokinetic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
  • Male and female participants of childbearing potential who agree to use contraceptive methods

Exclusion Criteria:

  • Have a history of diabetes or current diagnosis of diabetes
  • History or presence of a of significant bleeding disorder
  • Participants with significant comorbidity
  • Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index

Sites / Locations

  • Covance Clinical Research Unit
  • Covance Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LY3437943 + Drug Cocktail

Arm Description

Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
PK: AUC[0-∞] of Midazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam
PK: Cmax of Midazolam
PK: AUC[0-∞] of Warfarin
PK: AUC[0-∞] of Warfarin
PK: Cmax of Warfarin
PK: Cmax of Warfarin
PK: AUC[0-∞] of Caffeine
PK: AUC[0-∞] of Caffeine
PK: Cmax of Caffeine
PK: Cmax of Caffeine

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
April 17, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05445232
Brief Title
A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants
Official Title
A Multiple-Dose Drug-Drug Interaction Study to Determine the Effect of LY3437943 on Drug Metabolizing Enzymes
Study Type
Interventional

2. Study Status

Record Verification Date
April 1, 2023
Overall Recruitment Status
Completed
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 2023 (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 main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Overweight, Obesity, Drug Interaction, Cocktail, Pharmacokinetic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3437943 + Drug Cocktail
Arm Type
Experimental
Arm Description
Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.
Intervention Type
Drug
Intervention Name(s)
LY3437943
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Description
PK: AUC[0-∞] of Midazolam
Time Frame
Predose up to 24 hours postdose
Title
PK: Maximum Observed Concentration (Cmax) of Midazolam
Description
PK: Cmax of Midazolam
Time Frame
Predose up to 24 hours postdose
Title
PK: AUC[0-∞] of Warfarin
Description
PK: AUC[0-∞] of Warfarin
Time Frame
Predose up to 96 hours postdose
Title
PK: Cmax of Warfarin
Description
PK: Cmax of Warfarin
Time Frame
Predose up to 96 hours postdose
Title
PK: AUC[0-∞] of Caffeine
Description
PK: AUC[0-∞] of Caffeine
Time Frame
Predose up to 48 hours postdose
Title
PK: Cmax of Caffeine
Description
PK: Cmax of Caffeine
Time Frame
Predose up to 48 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²) Male and female participants of childbearing potential who agree to use contraceptive methods Exclusion Criteria: Have a history of diabetes or current diagnosis of diabetes History or presence of a of significant bleeding disorder Participants with significant comorbidity Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index
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
Covance Clinical Research Unit
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Covance Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

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