Trial results for Orforglipron (LY3502970) in adult participants with Type 2 Diabetes and inadequate glycemic control were posted on ClinicalTrials.gov on 2026-04-22. The Phase 3 study showed that the 12 mg Orforglipron dose led to a least squares mean HbA1c reduction of -1.59%, compared to -0.15% for placebo. Additionally, 81.25% of participants on the 12 mg dose achieved an HbA1c target of less than 7.0%, significantly higher than the 37.11% in the placebo group.
Background
The study, titled "A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone," aimed to determine the safety and efficacy of Orforglipron in this patient population.
Trial design
The study (NCT05971940) was a Phase 3, randomized, placebo-controlled trial that enrolled 559 adult participants with Type 2 Diabetes and inadequate glycemic control with diet and exercise alone. Participants were assigned to receive either Orforglipron (at doses of 3 mg, 12 mg, or 36 mg) or placebo. The study duration was approximately 54 weeks.
Key results
The trial results demonstrated significant improvements in glycemic control with Orforglipron compared to placebo.
- For "Change From Baseline in HbA1c":
- Placebo group showed a least squares mean change of -0.15 percentage of HbA1c (Standard Error: 0.113).
- 3 mg Orforglipron group showed a least squares mean change of -1.26 percentage of HbA1c (Standard Error: 0.114).
- 12 mg Orforglipron group showed a least squares mean change of -1.59 percentage of HbA1c (Standard Error: 0.087).
- 36 mg Orforglipron group showed a least squares mean change of -1.45 percentage of HbA1c (Standard Error: 0.104).
- For "Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)":
- 37.11% of participants in the placebo group achieved this target.
- 78.15% in the 3 mg Orforglipron group, 81.25% in the 12 mg Orforglipron group, and 78.99% in the 36 mg Orforglipron group achieved this target.
- For "Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)":
- 18.56% of participants in the placebo group achieved this target.
- 66.39% in the 3 mg Orforglipron group, 68.75% in the 12 mg Orforglipron group, and 68.91% in the 36 mg Orforglipron group achieved this target.
Key analyses further supported these findings:
- Mixed Models Analysis showed the Least Square (LS) Mean Difference (Net) for HbA1c change from baseline compared to placebo was -1.12 (95.0% CI: -1.43 to -0.8) for 3 mg Orforglipron (p-value: 0.001), -1.44 (95.0% CI: -1.72 to -1.16) for 12 mg Orforglipron (p-value: 0.001), and -1.3 (95.0% CI: -1.61 to -1.0) for 36 mg Orforglipron (p-value: 0.001).
- Logistic Regression analysis for achieving an HbA1c target of < 7.0% showed Risk Differences (RD) compared to placebo of 44.9 (95.0% CI: 34.41 to 55.39) for 3 mg Orforglipron (p-value: 0.001), 48.22 (95.0% CI: 37.5 to 58.93) for 12 mg Orforglipron (p-value: 0.001), and 46.94 (95.0% CI: 36.61 to 57.28) for 36 mg Orforglipron (p-value: 0.001).
What this means
The results from this Phase 3 trial indicate that Orforglipron significantly improves glycemic control in adult participants with Type 2 Diabetes who have inadequate control with diet and exercise alone. All tested doses of Orforglipron demonstrated superior HbA1c reduction and a higher proportion of participants achieving target glycemic levels compared to placebo. The 12 mg dose notably achieved the largest mean HbA1c reduction and the highest percentage of participants reaching an HbA1c target of less than 7.0%, suggesting its potential as an effective treatment option for managing Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05971940, titled "A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone," were posted on 2026-04-22 on clinicaltrials.gov.