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.

In Japanese adults with type 2 diabetes, 52-week add-on oral orforglipron shows an acceptable safety profile, with treatment-emergent adverse events in 85% overall.

• Why it matters: Orforglipron needs further long-term safety evaluation in East Asian populations, where type 2 diabetes may differ in underlying characteristics.
• What they did: In a multicentre, randomised, open-label phase 3 trial in Japan, 401 participants received once-daily orforglipron 3 mg, 12 mg, or 36 mg for 52 weeks, with safety assessed in all who received at least one dose.
• The result: Treatment-emergent adverse events were more frequent with 36 mg (88%) than 3 mg (81%) or 12 mg (84%), and discontinuations due to adverse events were 14% with 36 mg versus 5% with 3 mg and 8% with 12 mg.

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