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

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05445232
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3437943 — DRUG
    Administered SC.
  • Midazolam — DRUG
    Administered orally.
  • Warfarin — DRUG
    Administered orally.
  • Caffeine — DRUG
    Administered orally.

Study Details

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.

Key Dates

Start date
Jul 8, 2022
Status verified
Apr 2023
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3437943 + Drug Cocktail
    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 Measure

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Covance Clinical Research UnitDaytona BeachFlorida32117-
Covance DallasDallasTexas75247-

Find similar trials in Daytona Beach, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Covance Clinical Research Unit· Daytona Beach, FLCovance Dallas· Dallas, TX

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