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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05445232
Enrollment
32
Registered
2022-07-06
Start date
2022-07-08
Completion date
2023-02-24
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Overweight, Obesity, Drug Interaction, Cocktail, Pharmacokinetic

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.

Interventions

DRUGLY3437943

Administered SC.

DRUGMidazolam

Administered orally.

DRUGWarfarin

Administered orally.

DRUGCaffeine

Administered orally.

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of MidazolamPredose up to 24 hours postdosePK: AUC\[0-∞\] of Midazolam
PK: Maximum Observed Concentration (Cmax) of MidazolamPredose up to 24 hours postdosePK: Cmax of Midazolam
PK: AUC[0-∞] of WarfarinPredose up to 96 hours postdosePK: AUC\[0-∞\] of Warfarin
PK: Cmax of WarfarinPredose up to 96 hours postdosePK: Cmax of Warfarin
PK: AUC[0-∞] of CaffeinePredose up to 48 hours postdosePK: AUC\[0-∞\] of Caffeine
PK: Cmax of CaffeinePredose up to 48 hours postdosePK: Cmax of Caffeine

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026