A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN

简要总结

主要结局

次要结局

• Number of Participants With Hypoglycemia TEAEs(Up to 21 weeks.)
• Change From Baseline in Fasting Insulin Over 16 Weeks(From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.)
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to 21 weeks.)
• Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria(Up to 21 weeks.)
• Change From Baseline in Fasting Glucose Over 16 Weeks(From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.)
• Cumulative Number of Participants With Clinical Laboratory Abnormalities(Up to 21 weeks.)
• Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria(Up to 21 weeks.)
• Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks(From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.)
• Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks(From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.)
• Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks(From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.)
• Change From Baseline in HbA1c at All Timepoints Other Than Week 16(From Baseline to Week 2, Week, 4, Week 8, and Week 12.)