At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 164 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
PF-06835919 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Placebo and PF-06835919 for Non-alcoholic Steatohepatitis. Completed, enrolled 164 participants across 106 sites in 2 countries.
Detailed Summary
This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-alcoholic Steatohepatitis
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJul 2019
Primary CompletionMar 2021
Study CompletionMar 2021
TodayJul 2026
First PostedMay 31, 2019
Enrollment StartJul 18, 2019
Primary CompletionMar 2, 2021
Study CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.1 years ago
Interventions
Placebodrug
Placebo
PF-06835919drug
150 mg once daily
PF-06835919drug
300 mg once daily