This phase 3 trial evaluated the 52-week safety of once-daily oral orforglipron (3 mg, 12 mg, or 36 mg) as add-on therapy to diet/exercise alone or 1–2 oral antihyperglycaemic medications in 401 Japanese adults with type 2 diabetes.
TEAEs occurred in 85% of participants overall, most mild-to-moderate; discontinuations due to adverse events were dose-dependent (3 mg: 5%, 12 mg: 8%, 36 mg: 14%), driven mainly by GI symptoms. No severe (level 3) hypoglycaemia occurred; level 2 hypoglycaemia was rare (2% each in the 12 mg and 36 mg groups).
Open-label design may introduce reporting bias; the study was limited to Japanese participants, restricting generalisability to other East Asian or global populations; no placebo or active comparator arm was included.
Oral orforglipron appears to have an acceptable safety profile over 52 weeks in Japanese patients with type 2 diabetes, but GI-related discontinuations increase notably at the 36 mg dose — consider starting at lower doses and titrating carefully to balance tolerability.
Explore related topics
