A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
Summary
The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.
Timeline
- Start
- 2024-06-24
- Primary completion
- 2025-06-02
- Completion
- 2025-06-02
Outcome
Met primary endpoint
paper Bioequivalence was demonstrated between capsules and dose-adjusted tablets across all six doses. PMID 41994902 ↗
paper The 90% confidence interval of the ratios of the geometric least-squares means of AUC0-24,ss and C max,ss between each capsule dose and corresponding tablet dose met the predefined criteria for bioequivalence. PMID 41994902 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orforglipron | Small molecule | 0.8 mg | Oral |
| Subject | Orforglipron | Small molecule | 1 mg | Oral |
| Subject | Orforglipron | Small molecule | 2.5 mg | Oral |
| Subject | Orforglipron | Small molecule | 3 mg | Oral |
| Subject | Orforglipron | Small molecule | 5.5 mg | Oral |
| Subject | Orforglipron | Small molecule | 6 mg | Oral |
| Subject | Orforglipron | Small molecule | 9 mg | Oral |
| Subject | Orforglipron | Small molecule | 12 mg | Oral |
| Subject | Orforglipron | Small molecule | 14.5 mg | Oral |
| Subject | Orforglipron | Small molecule | 17.2 mg | Oral |
| Subject | Orforglipron | Small molecule | 24 mg | Oral |
| Subject | Orforglipron | Small molecule | 36 mg | Oral |