A phase 2a, randomized, double‐blind, placebo‐controlled, three‐arm, parallel‐group study to assess the efficacy, safety, tolerability and pharmacodynamics of PF ‐06835919 in patients with non‐alcoholic fatty liver disease and type 2 diabetes
Authors' conclusion
PF-06835919 administration over 16 weeks was generally safe and well tolerated and resulted in reductions in WLF in participants with NAFLD and T2D.
Study context
- Population
- Adults with non-alcoholic fatty liver disease (NAFLD) (≥8% whole liver fat on MRI-PDFF) and T2D on stable metformin (≥500 mg/day)145 completed
- Participants
- 164 adults
- Comparison
- PF-06835919 150 or 300 mg once daily vs placebo
- Placebon = 50reference
- PF-06835919 150 mgn = 46
- PF-06835919 300 mgn = 49
- Primary endpoint
- Percentage change from baseline in whole liver fat (MRI-PDFF); co-primary: change from baseline in HbA1c
- Follow-up
- 16 weeks
Methodological detailsphase 2a, double-blind, placebo-controlled, three-arm, parallel-group, Randomization 1:1:1 via interactive response technology
- Phase 2a
- Double-blind
- Placebo-controlled
- Three-arm
- Parallel-group
- Randomization 1:1:1 via interactive response technology
Primary result
As reported in the abstract
Percentage change from baseline in whole liver fat (LS mean) · week 16
Placebo
−5.26%
least squares mean · 90% CI −12.86%–2.99%
PF-06835919 150 mg
−17.05%
least squares mean · 90% CI −24.01%–-9.46%
PF-06835919 300 mg
−19.13%
least squares mean · 90% CI −25.51%–-12.20%
P = 0.0288
Safety
Treatment-emergent adverse events
Treatment-emergent adverse events
- Incidence similar across groups, no apparent dose-related trend
Original publication
A phase 2a, randomized, double‐blind, placebo‐controlled, three‐arm, parallel‐group study to assess the efficacy, safety, tolerability and pharmacodynamics of PF ‐06835919 in patients with non‐alcoholic fatty liver disease and type 2 diabetes. Diabetes Obes Metab. Published 17 January 2023. doi:10.
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