Results from a PHASE1 study (NCT05086445) investigating Orforglipron (LY3502970) in Japanese participants with Type 2 Diabetes Mellitus were posted on 2026-07-16. The trial, which enrolled 62 participants, primarily assessed safety and pharmacokinetics. It reported varying numbers of treatment-emergent adverse events (TEAEs) across different dose groups, with no serious adverse events (SAEs) considered related to the study drug.

Background

Orforglipron (LY3502970) was investigated for its safety profile and pharmacokinetics in Japanese participants diagnosed with Type 2 Diabetes Mellitus.

Trial design

The study, identified as NCT05086445, was a PHASE1 trial that enrolled 62 participants with Type 2 Diabetes Mellitus. The trial's main purpose was to evaluate the side effects of LY3502970 and to understand how the body processes and is affected by the study drug. Participants received either LY3502970 at various doses or placebo.

Key results

The study primarily reported on the number of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) considered related to the study drug. Across all groups, no participants experienced serious adverse events (SAEs) considered related to study drug administration.

The number of participants with one or more TEAEs considered related to study drug administration were:

  • Placebo - Part A: 2 participants
  • 2 mg LY3502970 - Part A: 5 participants
  • 3 mg LY3502970 - Part A: 5 participants
  • Placebo QD - Part B: 4 participants
  • 2(or 3)/3/6/12 mg LY3502970 QD - Part B: 11 participants
  • 2/3/6/8/12/24 mg LY3502970 QD - Part B: 12 participants
  • 2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B: 9 participants

Additionally, the trial reported several Least Squares Mean Differences (LS Mean Differences) with 90.0% confidence intervals, though specific outcome titles for these analyses were not provided:

  • LS Mean Difference: -72.22 (CI: -85.35, -59.09)
  • LS Mean Difference: -68.48 (CI: -81.46, -55.5)
  • LS Mean Difference: -72.97 (CI: -85.64, -60.3)
  • LS Mean Difference: -2.83 (CI: -3.38, -2.28)
  • LS Mean Difference: -2.84 (CI: -3.38, -2.3)
  • LS Mean Difference: -2.95 (CI: -3.48, -2.42)

What this means

The results from this PHASE1 study indicate that Orforglipron generally demonstrated a tolerable safety profile in Japanese participants with Type 2 Diabetes Mellitus, particularly with the absence of any serious adverse events considered related to the study drug. The presence of treatment-emergent adverse events across dose groups is typical for early-phase trials and helps characterize the drug's safety profile. The reported Least Squares Mean Differences, although without specific outcome labels, suggest a consistent directional effect on certain measured parameters, which would typically be further explored in subsequent phases.

Source

This information was sourced from ClinicalTrials.gov, documenting the results of trial NCT05086445, which were posted on 2026-07-16. The study details are available on clinicaltrials.gov.