台灣臨床試驗主持人資料庫|TPIDB

問卷

Log In

繁中 EN

TPIDB

TPIDB Outstanding PI

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberC2541013

NCT Number(ClinicalTrials.gov Identfier)NCT04321031

Completed

2020-11-06 - 2023-12-26

Phase II

Not yet recruiting2

Recruiting5

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP 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

Sponsor

Pfizer
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Yi-Hsiang Huang Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Nan Cheng Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 顏旭亨無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳啟益無

Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Juei Jeng Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Jia-Horng Kao Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jee-Fu Huang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3

Objectives

The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).

Test Drug

PF-06865571PF-05221304

Active Ingredient

PF-06865571
PF-05221304

Dosage Form

Tablets
Tablets

Dosage

25 mg, 50 mg and 150 mg
5mg, 10mg

Endpoints

Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1>/= or both [ Time Frame: Week 48 ]
Proportion of participants achieving resolution of NASH without worsening of fibrosis or improvement in fibrosis by ≥1 stage without worsening of NASH or both

Inclution Criteria

Inclusion Criteria:

Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
BMI >/= 22.5kg/m2

Exclusion Criteria

Exclusion Criteria:

Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-unstable liver function tests, recent cardiovascular event(s) significant malignancies,

The Estimated Number of Participants

Taiwan

18 participants
Global

450 participants