Trial results for Orforglipron (LY3502970) in healthy participants were posted on 2026-07-10. The PHASE1 study (NCT03929744), which enrolled 133 participants, reported zero serious adverse events (SAEs) considered related to the study drug across all dose groups and parts of the study.

Background

Orforglipron (LY3502970) was investigated in healthy individuals. The study aimed to determine the safety and any side effects associated with the drug, as well as how much of the drug gets into the bloodstream and how long it takes the body to get rid of it.

Trial design

The study, identified as NCT03929744, was a PHASE1 study that enrolled 133 healthy participants. The main purposes were to determine the safety and side effects of LY3502970, and to understand its pharmacokinetics. The study was divided into 5 parts (A, B, C, D, and E). Parts A and D involved a single dose of LY3502970 and lasted approximately 15 days. Parts B and E involved multiple doses of LY3502970 and lasted about 4 weeks. Part C involved two single doses of LY3502970 and lasted about 29 days. Each participant enrolled in only one part of the study. Interventions included various doses of LY3502970, placebo, and other drugs such as atorvastatin, simvastatin, and midazolam.

Key results

The study evaluated the number of participants with one or more serious adverse events (SAEs) considered by the investigator to be related to the study drug across various dose groups in Parts A and B. The results showed zero participants in any of the following groups experienced a related SAE:

  • Part A Placebo: 0 participants
  • Part A 0.3 mg LY3502970: 0 participants
  • Part A 1 mg LY3502970: 0 participants
  • Part A 3 mg LY3502970: 0 participants
  • Part A 6 mg LY3502970: 0 participants
  • Part B Placebo: 0 participants
  • Part B: 2 mg LY3502970: 0 participants
  • Part B: 4 mg LY3502970: 0 participants
  • Part B: 5 mg LY3502970: 0 participants
  • Part B: 6 mg LY3502970: 0 participants
  • Part B: 8 mg LY3502970: 0 participants
  • Part B: 12 mg LY3502970: 0 participants

These findings indicate a favorable safety profile regarding serious adverse events related to LY3502970 in this PHASE1 study.

What this means

The results from this PHASE1 study of Orforglipron in healthy participants suggest a favorable early safety profile, with no serious adverse events reported as related to the study drug across various single and multiple dose regimens. This finding is crucial for the continued development of Orforglipron, as demonstrating safety in initial human trials is a primary objective. While the study also aimed to characterize pharmacokinetics, specific pharmacokinetic measurements were not detailed in the posted outcome data.

Source

These trial results were posted on ClinicalTrials.gov on 2026-07-10. The full details of the study, NCT03929744, are available on clinicaltrials.gov.