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

April 17, 2023 updated by: Eli Lilly and Company

A Multiple-Dose Drug-Drug Interaction Study to Determine the Effect of LY3437943 on Drug Metabolizing Enzymes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Covance Clinical Research Unit
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3437943 + Drug Cocktail

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.
Drug: Midazolam
Administered orally.
Drug: LY3437943
Administered SC.
Drug: Warfarin
Administered orally.
Drug: Caffeine
Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Time Frame: Predose up to 24 hours postdose
PK: AUC[0-∞] of Midazolam
Predose up to 24 hours postdose
PK: Maximum Observed Concentration (Cmax) of Midazolam
Time Frame: Predose up to 24 hours postdose
PK: Cmax of Midazolam
Predose up to 24 hours postdose
PK: AUC[0-∞] of Warfarin
Time Frame: Predose up to 96 hours postdose
PK: AUC[0-∞] of Warfarin
Predose up to 96 hours postdose
PK: Cmax of Warfarin
Time Frame: Predose up to 96 hours postdose
PK: Cmax of Warfarin
Predose up to 96 hours postdose
PK: AUC[0-∞] of Caffeine
Time Frame: Predose up to 48 hours postdose
PK: AUC[0-∞] of Caffeine
Predose up to 48 hours postdose
PK: Cmax of Caffeine
Time Frame: Predose up to 48 hours postdose
PK: Cmax of Caffeine
Predose up to 48 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2022

Primary Completion (Actual)

February 24, 2023

Study Completion (Actual)

February 24, 2023

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18476
  • J1I-MC-GZBI (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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