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A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
Sponsor: Eli Lilly and Company
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
Conditions
Interventions
Orforglipron
Administered orally.
Simvastatin
Administered orally.
Digoxin
Administered orally.
Rosuvastatin
Administered orally.
Acetaminophen
Administered orally.
Midazolam
Administered orally.
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