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Trial record 1 of 1 for:    NCT04321031
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Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) (MIRNA)

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ClinicalTrials.gov Identifier: NCT04321031
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Percent change in liver fat [ Time Frame: Week 48 ]
    Percent change in liver fat (assessed via MRI-PDFF)
  • Proportion of participants achieving Resolution of NASH, without worsening of fibrosis [ Time Frame: Week 48 ]
  • Proportion of participants achieving improvement in fibrosis by ≥1stage, without worsening of NASH [ Time Frame: Week 48 ]
  • Proportion of participants with Improvement in fibrosis by ≥2 stages, without worsening of NASH [ Time Frame: Week 48 ]
  • Proportion of participants with Improvement of ≥2 points in Total NASH [ Time Frame: Week 48 ]
  • Proportion of participants with a clinically significant change from baseline in vital signs [ Time Frame: Baseline to Week 50 ]
  • Proportion of participants with a clinically significant change from baseline in laboratory values [ Time Frame: Baseline to Week 50 ]
  • Proportion of participants with a clinically significant change from baseline in electrocardiograms (ECG) parameters [ Time Frame: Baseline to Week 50 ]
  • Proportion of participants with treatment-emergent adverse events (TEAE) [ Time Frame: Baseline to Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
dose ranging, dose finding
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind, double dummy, placebo controlled
Primary Purpose: Basic Science
Condition  ICMJE
  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis With Liver Fibrosis
Intervention  ICMJE
  • Drug: Placebo
    Tablet
  • Drug: PF-06865571
    Tablet
  • Drug: PF-05221304
    Tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    participants will receive medication for 48 weeks
    Intervention: Drug: Placebo
  • Experimental: PF-06865571 25 milligrams (mg) twice daily (BID)
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 75 mg BID
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 150 mg BID
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 300 mg BID
    participants will receive medication for 48 weeks
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 150 mg once daily (QD) + placebo QD
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: Placebo
    • Drug: PF-06865571
  • Experimental: PF-06865571 300 mg QD + placebo QD
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: Placebo
    • Drug: PF-06865571
  • Experimental: PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
  • Experimental: PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)
    participants will receive medication for 48 weeks
    Interventions:
    • Drug: PF-06865571
    • Drug: PF-05221304
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04321031
Other Study ID Numbers  ICMJE C2541013
2019-004775-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP