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COMPLETED
NCT06186622
PHASE1

A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and together with orforglipron) that enters the bloodstream and how long it takes the body to eliminate them when administered orally in healthy overweight and obese participants. In addition, the effect of the orforglipron tablet on the amount of simvastatin that enters the bloodstream and how long it takes the body to eliminate it will be evaluated. The study will also assess the effect of sodium bicarbonate when administered alone with simvastatin versus orforglipron capsule containing sodium bicarbonate administered with simvastatin. The safety and tolerability of orforglipron and information about any side effects experienced will be collected. Study will be conducted in two parts, with part 1 and 2 lasting up to approximately 23 and 24 weeks each, including the screening period.

Official title: A Drug-Drug Interaction Study to Assess the Effect of Orforglipron on the Pharmacokinetics of Digoxin, Simvastatin, Rosuvastatin, Acetaminophen, and Midazolam in Healthy Overweight and Obese Participants

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-01-02

Completion Date

2024-07-10

Last Updated

2026-05-22

Healthy Volunteers

Yes

Interventions

DRUG

Orforglipron

Administered orally.

DRUG

Simvastatin

Administered orally.

DRUG

Digoxin

Administered orally.

DRUG

Rosuvastatin

Administered orally.

DRUG

Acetaminophen

Administered orally.

DRUG

Midazolam

Administered orally.

DRUG

Sodium Bicarbonate

Administered orally.

Locations (2)

Fortrea Clinical Research Unit Inc.

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit Inc.

Dallas, Texas, United States