04Jan 2023
A phase 2a, randomized, double‐blind, placebo‐controlled, 3‐arm, parallel‐group study to assess the efficacy, safety, tolerability, and pharmacodynamics of PF‐06835919 in patients with nonalcoholic fatty liver disease and type 2 diabetes mellitus

A phase 2a, randomized, double‐blind, placebo‐controlled, 3‐arm, parallel‐group study to assess the efficacy, safety, tolerability, and pharmacodynamics of PF‐06835919 in patients with nonalcoholic fatty liver disease and type 2 diabetes mellitus

To assess the safety, tolerability, and pharmacodynamics (PD) of ketohexokinase inhibitor PF‐06835919 in participants with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM). This double‐blind, placebo‐controlled, parallel‐group study enrolled adults with NAFLD and T2DM on stable doses of metformin ≥500 mg/day. Modest numerical reductions in HbA1c were observed in all groups that did not reach statistical significance. Treatment‐emergent adverse event incidence was similar across groups with no apparent dose‐related trend. PF‐06835919 administration over 16 weeks was generally safe and well‐tolerated, resulting in reductions in WLF in participants with NAFLD and T2DM.

  • #endo-diabetology

Like

Save

Share