Trial results for a Phase 1 study evaluating two different formulations of Orforglipron (LY3502970) in healthy participants were posted on ClinicalTrials.gov on 2026-05-27. The study found that both 16 mg formulations demonstrated similar pharmacokinetic profiles, with a geometric mean maximum observed concentration (Cmax) of 86.5 ng/mL and geometric mean area under the plasma concentration-time curve (AUC (0-24)) values of approximately 1260 ng*h/mL and 1240 ng*h/mL, respectively.
Background
The study investigated two different formulations of LY3502970, also known as Orforglipron. This research aimed to compare the pharmacokinetics, safety, and tolerability of these formulations in healthy individuals.
Trial design
The completed Phase 1 study (NCT05341089) enrolled 39 healthy participants. The main purpose of the study was to conduct blood tests to measure the concentration of LY3502970 in the bloodstream when administered as two different formulations. Additionally, the study evaluated the safety and tolerability of LY3502970. The study duration was up to 13 weeks, excluding the screening period.
Key results
The trial reported pharmacokinetic data for two 16 mg formulations of LY3502970:
- For Formulation 1, the geometric mean maximum observed concentration (Cmax) was 86.5 ng/mL, with a geometric coefficient of variation of 40%. The geometric mean area under the plasma concentration-time curve from 0 to 24 hours (AUC (0-24)) was 1260 ng*h/mL, with a geometric coefficient of variation of 38%. The median time to maximum observed concentration (Tmax) was 6.00 hours.
- For Formulation 2, the geometric mean Cmax was also 86.5 ng/mL, with a geometric coefficient of variation of 43%. The geometric mean AUC (0-24) was 1240 ng*h/mL, with a geometric coefficient of variation of 40%. The median Tmax was also 6.00 hours.
What this means
The results from this Phase 1 study indicate that two different formulations of Orforglipron (LY3502970), both at a 16 mg dose, exhibit highly similar pharmacokinetic profiles in healthy participants. The near-identical geometric mean Cmax values of 86.5 ng/mL for both formulations, along with very close geometric mean AUC (0-24) values (1260 ng*h/mL for Formulation 1 and 1240 ng*h/mL for Formulation 2), suggest comparable absorption and systemic exposure. The identical median Tmax of 6.00 hours further supports similar absorption rates. These findings are crucial for drug development, as they may suggest that both formulations could be therapeutically equivalent or offer flexibility in manufacturing or administration without significantly altering the drug's exposure in the body. The study also evaluated safety and tolerability, though specific adverse event data was not detailed in the posted results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05341089, titled "A Study of Two Different Formulations of LY3502970 in Healthy Participants", were posted on 2026-05-27 on clinicaltrials.gov.