drugset / Trial / NCT06440980

A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

NCT06440980 ↗

Phase 1 Completed 533 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelBasic science

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

EvaluationDrugModalityDoseRoute
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

Indications