Trial results for a Phase 1 study of Orforglipron (LY3502970) in healthy participants were posted on ClinicalTrials.gov on 2026-05-29. The study assessed the pharmacokinetics of multiple oral doses, reporting geometric mean maximum observed concentrations (Cmax) up to 111 nanograms per milliliter (ng/mL) and area under the concentration-time curve (AUC(0-24)) up to 1480 nanogram*hours per milliliter (ng*h/mL).
Background
The study investigated the pharmacokinetics of LY3502970 (Orforglipron) following multiple oral doses. Its primary objective was to compare the absorption rate and elimination time of a new formulation of LY3502970 against a reference formulation in healthy individuals. The trial also collected information regarding the safety and tolerability of the drug.
Trial design
The completed Phase 1 study (NCT05051566) enrolled 26 healthy participants. The trial was designed to evaluate the pharmacokinetics of LY3502970 (Orforglipron) when administered in multiple oral doses, comparing a new formulation to a reference formulation. The study was conducted in two parts and lasted up to approximately 6 months, inclusive of the screening period.
Key results
The trial reported pharmacokinetic measurements for LY3502970 (Orforglipron) in healthy participants, comparing different formulations or study arms designated as Part A and Part B:
- For Part A, the geometric mean maximum observed concentration (Cmax) values were 66.2 ng/mL (Geometric Coefficient of Variation: 77.4), 111 ng/mL (Geometric Coefficient of Variation: 81.2), and 97.4 ng/mL (Geometric Coefficient of Variation: 58.9).
- For Part A, the geometric mean area under the concentration versus time curve from time 0 to 24 hours post-dose (AUC(0-24)) values were 988 ng*h/mL (Geometric Coefficient of Variation: 66.9), 1480 ng*h/mL (Geometric Coefficient of Variation: 75.2), and 1400 ng*h/mL (Geometric Coefficient of Variation: 51.2).
- For Part A, the median time of maximum observed concentration (Tmax) values were 7.02 hours, 8 hours, and 8 hours.
- For Part B, the geometric mean maximum observed concentration (Cmax) values were 63.4 ng/mL (Geometric Coefficient of Variation: 32.2), 56.3 ng/mL (Geometric Coefficient of Variation: 29.6), and 59.6 ng/mL (Geometric Coefficient of Variation: 51.0).
No adverse event summary was provided in the posted results.
What this means
The posted results from this Phase 1 study provide initial pharmacokinetic data for Orforglipron (LY3502970) in healthy individuals. The reported Cmax and AUC(0-24) values, along with their coefficients of variation, offer insights into the absorption and exposure characteristics of different oral formulations of the drug. These findings are crucial for understanding the drug's behavior in the human body and will inform the selection of formulations and dosing strategies for subsequent clinical development phases. The Tmax data indicates the time required to reach peak plasma concentrations. As a Phase 1 study, the primary focus is on pharmacokinetics and safety, and these results contribute to building the foundational understanding necessary for further clinical investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05051566, titled "A Multiple Dose Study of LY3502970 in Healthy Participants", were posted on 2026-05-29 on clinicaltrials.gov.