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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2023-02-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC.

Midazolam

Intervention Type DRUG

Administered orally.

Warfarin

Intervention Type DRUG

Administered orally.

Caffeine

Intervention Type DRUG

Administered orally.

Interventions

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LY3437943

Administered SC.

Intervention Type DRUG

Midazolam

Administered orally.

Intervention Type DRUG

Warfarin

Administered orally.

Intervention Type DRUG

Caffeine

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No