A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants
Phase 1
Completed
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT05445232
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description LY3437943 + Drug Cocktail LY3437943 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. LY3437943 + Drug Cocktail Midazolam 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. LY3437943 + Drug Cocktail Warfarin 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. LY3437943 + Drug Cocktail Caffeine 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.
- Primary Outcome Measures
Name Time Method 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: Cmax of Warfarin Predose up to 96 hours postdose PK: Cmax of Warfarin
PK: Cmax of Caffeine Predose up to 48 hours postdose PK: Cmax of Caffeine
PK: AUC[0-∞] of Warfarin Predose up to 96 hours postdose PK: AUC\[0-∞\] of Warfarin
PK: AUC[0-∞] of Caffeine Predose up to 48 hours postdose PK: AUC\[0-∞\] of Caffeine
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Covance Dallas
🇺🇸Dallas, Texas, United States
Covance Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States