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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, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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).

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis With Liver Fibrosis Drug: Placebo Drug: PF-06865571 Drug: PF-05221304 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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
Official Title: 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
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : November 29, 2023
Estimated Study Completion Date : December 26, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
participants will receive medication for 48 weeks
 Drug: Placebo
Tablet
Experimental: PF-06865571 25 milligrams (mg) twice daily (BID)
participants will receive medication for 48 weeks
 Drug: PF-06865571
Tablet
Experimental: PF-06865571 75 mg BID
participants will receive medication for 48 weeks
 Drug: PF-06865571
Tablet
Experimental: PF-06865571 150 mg BID
participants will receive medication for 48 weeks
 Drug: PF-06865571
Tablet
Experimental: PF-06865571 300 mg BID
participants will receive medication for 48 weeks
 Drug: PF-06865571
Tablet
Experimental: PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)
participants will receive medication for 48 weeks
 Drug: PF-06865571
Tablet

Drug: PF-05221304
Tablet
Experimental: PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)
participants will receive medication for 48 weeks
 Drug: PF-06865571
Tablet

Drug: PF-05221304
Tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percent change in liver fat [ Time Frame: Week 48 ]
    Percent change in liver fat (assessed via MRI-PDFF)

  2. Proportion of participants achieving Resolution of NASH, without worsening of fibrosis [ Time Frame: Week 48 ]
  3. Proportion of participants achieving improvement in fibrosis by ≥1stage, without worsening of NASH [ Time Frame: Week 48 ]
  4. Proportion of participants with Improvement in fibrosis by ≥2 stages, without worsening of NASH [ Time Frame: Week 48 ]
  5. Proportion of participants with Improvement of ≥2 points in Total NASH [ Time Frame: Week 48 ]
  6. Proportion of participants with a clinically significant change from baseline in vital signs [ Time Frame: Baseline to Week 50 ]
  7. Proportion of participants with a clinically significant change from baseline in laboratory values [ Time Frame: Baseline to Week 50 ]
  8. Proportion of participants with a clinically significant change from baseline in electrocardiograms (ECG) parameters [ Time Frame: Baseline to Week 50 ]
  9. Proportion of participants with treatment-emergent adverse events (TEAE) [ Time Frame: Baseline to Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321031


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04321031    
Other Study ID Numbers: C2541013
2019-004775-39 ( EudraCT Number )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
 Fibrosis
Pathologic Processes
Digestive System Diseases