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

Lilly

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Midazolam; Drug: Caffeine; Drug: LY3437943; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05445232

18476

J1I-MC-GZBI (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 1 patient group

LY3437943 + Drug Cocktail

Experimental group

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.

Treatment:

Drug: LY3437943

Drug: Caffeine

Drug: Warfarin

Drug: Midazolam