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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05445232

Collaborator

(none)

Enrollment

Locations

Arm

6.5

Anticipated Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: LY3437943 Drug: Midazolam Drug: Warfarin Drug: Caffeine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 8, 2022

Anticipated Primary Completion Date :

Jan 23, 2023

Anticipated Study Completion Date :

Jan 23, 2023

Arms and Interventions

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

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: LY3437943

Administered SC.

Drug: Midazolam

Administered orally.

Drug: Warfarin

Administered orally.

Drug: Caffeine

Administered orally.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit	Daytona Beach	Florida	United States	32117
2	Covance Dallas	Dallas	Texas	United States	75247

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company