Hepatic Safety of Orforglipron in Adults With Obesity or Overweight and/or Type 2 Diabetes: A Pooled Analysis of the Orforglipron Phase 3 Clinical Trials.
Diabetes Obes MetabJun 23, 2026 (epub)
Sean Wharton, Adam Stefanski, Jiaxun Chen et al.
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In 30 seconds
This pooled analysis of seven Phase 3 clinical trials evaluated the hepatic safety of orforglipron in 11,220 adults with obesity or type 2 diabetes. The study found that orforglipron treatment did not lead to drug-induced liver injury, with no cases meeting Hy's Law criteria. Mean reductions in ALT/AST were observed, indicating a favorable hepatic profile.
Key findings
- Orforglipron treatment resulted in mean reductions in ALT/AST levels.
- No participants treated with orforglipron met the criteria for drug-induced liver injury/Hy's Law.
- The incidence of hepatic adverse events was balanced between orforglipron and comparators.
- Results were consistent in participants with normal and elevated baseline aminotransferases.
Why it matters
Understanding the hepatic safety profile of new treatments like orforglipron is crucial for clinicians managing patients with obesity and type 2 diabetes, particularly those with preexisting liver conditions. This study provides reassurance regarding liver safety.