NCT06186622

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Obese
• Overweight

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2024-01-02
• Last updated: 2024-07-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study