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Clinical Trials List

Protocol NumberC1171002
NCT Number(ClinicalTrials.gov Identfier)NCT03248882
Completed

2017-09-01 - 2019-01-03

Others

Terminated7

ICD-10K76.0

Fatty (change of) liver, not elsewhere classified

ICD-10K75.81

Nonalcoholic steatohepatitis (NASH)

ICD-9573.8

Other specified disorders of liver

A Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate safety, tolerability, and pharmacodynamics of PF-05221304 administered daily for 16-weeks to adult subjects with nonalcoholic fatty liver disease

  • Sponsor

    Pfizer Inc.

  • 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

1 Stop recruiting

Audit

None

Principal Investigator Wen-Juei Jeng Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Jing-Houng Wang Division of General Internal Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

  • 顏毅豪 Division of General Internal Medicine
  • 張國欽 Division of General Internal Medicine
  • 盧勝男 Division of General Internal Medicine
  • 紀廣明 Division of General Internal Medicine
  • 洪肇宏 Division of General Internal Medicine
  • 沈峰志 Division of General Internal Medicine
  • 陳建宏 Division of General Internal Medicine
  • 歐信佑 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 顏旭亨 Division of General Internal Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop 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 Stop recruiting

Audit

None

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 Stop recruiting

Principal Investigator Wan-Long Chuang Division of General Internal Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

nonalcoholic fatty liver disease

Objectives

This test is a clinical trial of PF-05221304 used in adult subjects with non-alcoholic fatty liver disease (NAFLD). The purpose is to observe the effect of placebo and 4 different doses of PF-05221304 on liver fat, and its safety and tolerability. In addition, it is also planned to evaluate the effect of PF-05221304 on other pharmacodynamics/exploratory parameters.

Test Drug

PF-05221304

Active Ingredient

PF-05221304-82 trihydrate

Dosage Form

Tablet

Dosage

1, 5, 25, 50 mg or Placebo Tablets

Endpoints

Primary objective:
To evaluate the dose-response for the effect on liver fat with a range of PF-05221304 doses administered daily in adults with nonalcoholic fatty liver disease (entire study population)
Secondary Objectives:
To evaluate the dose-response for the effect on ALT with a range of PF-05221304 doses administered daily in the 1st tier stratification comprising of adults with diagnosed/presumed nonalcoholic steatohepatitis, only;
To evaluate the safety and tolerability of a range of PF-05221304 doses administered daily in adults with nonalcoholic fatty liver disease (entire study population)

Inclution Criteria

You provide written consent to take part in this study – by signing this form
 You are between 21 (the minimum age of consent in Taiwan) and 70 years of age when you sign this consent form
 You agree to use effective contraception to prevent pregnancy if you are a man who can father a child or a woman who can become pregnant
 And while in the study, you cannot –
 have a woman partner/spouse who is/becomes pregnant, if you are a man
 become pregnant, if you are a woman
 you will be withdrawn if either of the above happens
 Your doctor determined that you have 1 of the following –
 NASH based on a biopsy of your liver done before you decided to consider this study (where a needle is used to puncture the liver and remove a small amount of liver tissue)
 NASH based on procedures and blood test results done as part of this study
 NAFLD based on procedures and blood test results done as part of this study
 You meet certain criteria that ensure you can fit and stay comfortably in the MRI machine (that takes pictures of your liver)
 You have a certain amount of liver fat needed as a minimum to allow testing of the study drug
 Procedures and tests will be done to check that your fatty liver is not due to drinking too much alcohol, taking medicines that cause this effect, or genetic determinants (ie, inherited from your parents)

Exclusion Criteria

You have 1 or more medical conditions but these are stable, you are taking allowed medicines, and have safety laboratory tests that indicate you meet requirements for this study

You agree not to take part in any other research study where you will receive another study drug while you are taking part in this research study.

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    360 participants

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