CTRI/2020/10/028440
Not yet recruiting
Phase 2
A phase 2, randomized, double-blind, double-dummy, Placebo-controlled, dose-ranging, dose-finding, parallelgroup study to assess efficacy and safety of PF-06865571 (DGAT2i) alone and when coadministered with PF-05221304 (ACCi) in adult participants with biopsy-confirmed nonalcoholic Steatohepatitis and fibrosis stage 2 or 3
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Sponsor
- Pfizer Inc
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\)Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
- •(2\)BMI more than or equal to 22\.5kg/m2
Exclusion Criteria
- •(1\)Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
- •(2\)Any condition possibly affecting drug absorption \-Unstable concomitant medical conditions, based on medical history or screening laboratory results including\-
- •(3\)unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Outcomes
Primary Outcomes
Not specified
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