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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05445232
• Other study ID #: 18476
• Secondary ID: J1I-MC-GZBI
• Status: Completed
• Phase: Phase 1
• Start date: July 8, 2022
• Est. completion date: February 24, 2023

Study information

• Verified date: April 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas
United States	Covance Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Midazolam	PK: AUC[0-8] of Midazolam	Predose up to 24 hours postdose
Primary	PK: Maximum Observed Concentration (Cmax) of Midazolam	PK: Cmax of Midazolam	Predose up to 24 hours postdose
Primary	PK: AUC[0-8] of Warfarin	PK: AUC[0-8] of Warfarin	Predose up to 96 hours postdose
Primary	PK: Cmax of Warfarin	PK: Cmax of Warfarin	Predose up to 96 hours postdose
Primary	PK: AUC[0-8] of Caffeine	PK: AUC[0-8] of Caffeine	Predose up to 48 hours postdose
Primary	PK: Cmax of Caffeine	PK: Cmax of Caffeine	Predose up to 48 hours postdose