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Clinical Trials/CTRI/2020/10/028440
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

Pfizer Inc0 sites0 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Pfizer Inc

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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