Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial.
Lancet Diabetes EndocrinolAug 17, 2026 (epub)
Clinical ResearchEndocrinology
Daisuke Yabe, Toshihiko Shiraiwa, Hiroyuki Ugai et al.
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In 30 seconds
This multicentre, randomised, open-label phase 3 trial evaluated the long-term safety of oral orforglipron in Japanese adults with type 2 diabetes. Among 401 participants, 85% experienced at least one treatment-emergent adverse event, with higher rates in the 36 mg group. The study highlights the safety profile of orforglipron over 52 weeks.
Key findings
- 85% of participants had at least one treatment-emergent adverse event, with the highest in the 36 mg group at 88%.
- 14% of participants in the 36 mg group discontinued due to adverse events compared to 5% in the 3 mg group.
- Gastrointestinal symptoms were the most common reasons for treatment discontinuation across all groups.
Why it matters
Understanding the safety profile of new diabetes treatments like orforglipron is crucial for clinicians managing type 2 diabetes, particularly in populations with distinct characteristics, such as Japanese patients.