A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Eli Lilly and Company
Study ID
NCT06704763
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Orforglipron — DRUG
    Administered orally
  • Midazolam — DRUG
    Administered orally
  • Quinidine — DRUG
    Administered orally

Study Details

The purpose of this study is to determine the effect of quinidine on the levels of orforglipron in the blood stream and how long it takes the body to eliminate it, when administered orally in healthy participants. The study will last up to approximately 8 weeks including screening.

Key Dates

Start date
Dec 6, 2024
Status verified
Apr 2026
Primary completion
Feb 5, 2025
Completion
Feb 5, 2025

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Midazolam + Orforglipron + Quinidine
    Participants received: * Day -1: single dose of 0.2 milligram (mg) midazolam. * Day 1: single dose of 1 mg orforglipron. * Days 5 to 6: 200 mg quinidine twice daily (BID). * Day 7: 200 mg quinidine BID plus a single dose of 0.2 mg midazolam. * Day 8: 200 mg quinidine BID plus a single dose of 1 mg orforglipron.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Orforglipron [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours post orforglipron dose on days 1, 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICONSalt Lake CityUtah84124-

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