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Completed

NCT Number: NCT05445232

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3437943

Drug

Administered SC.

midazolam

Drug

Administered orally.

Warfarin

Drug

Administered orally.

Caffeine

Drug

Administered orally.

Primary outcomes

  1. 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

  2. PK: Maximum Observed Concentration (Cmax) of Midazolam

    Time frame: Predose up to 24 hours postdose

    PK: Cmax of Midazolam

  3. PK: AUC[0-∞] of Warfarin

    Time frame: Predose up to 96 hours postdose

    PK: AUC[0-∞] of Warfarin

  4. PK: Cmax of Warfarin

    Time frame: Predose up to 96 hours postdose

    PK: Cmax of Warfarin

  5. PK: AUC[0-∞] of Caffeine

    Time frame: Predose up to 48 hours postdose

    PK: AUC[0-∞] of Caffeine

  6. PK: Cmax of Caffeine

    Time frame: Predose up to 48 hours postdose

    PK: Cmax of Caffeine

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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