A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
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.
Timeline
- Start
- 2024-01-02
- Primary completion
- 2024-07-10
- Completion
- 2024-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1000 mg | Oral |
| Subject | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Midazolam | Small molecule | 0.2 mg | Oral |
| Subject | Orforglipron | Small molecule | 36 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 20 mg | Oral |
| Subject | Simvastatin | Small molecule | 20 mg | Oral |
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 600 mg | Oral |