| Trial ID: | L0426 |
| Source ID: | EUCTR2019-004775-39-SK
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| Associated Drug: |
PF-05221304
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| 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
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS WITH FIBROSIS STAGE 2 OR 3 <br>MedDRA version: 24.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
<br>MedDRA version: 20.0
L
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| Interventions: |
<br>Product Name: DGAT2i tablets 25 mg<br>Product Code: PF-06865571 <br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PF-06865571<br>Current Sponsor code: PF-06865571<br>Other descriptive name: PF-06865571<br>Concentration unit: mg milligram(s)<br>C
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| Outcome Measures: |
Main Objective: To evaluate the effect of a range of DGAT2i doses administered alone, and coadministration of DGAT2i + ACCi, compared to placebo, and the coadministration of DGAT2i + ACCi relative to DGAT2i alone, in participants with biopsy confirmed NASH and fibrosis, on resolution of NASH without worsening of fibrosis or improvement in fibrosis by =1 stage without worsening of NASH, or both;Secondary Objective: 1. To evaluate the effect of a range of DGAT2i doses administered alone, and coadministration of DGAT2i + ACCi, compared to placebo, and the coadministration of DGAT2i + ACCi relative to DGAT2i alone, on liver fat.<br><br>2. To evaluate the effect of a range of DGAT2i doses administered alone, and coadministration of DGAT2i + ACCi, compared to placebo, and the coadministration of DGAT2i + ACCi relative to DGAT2i alone, in participants achieving improvement in different responder definitions.<br><br>3. To assess the safety and tolerability with a range of DGAT2i doses administered alone, and coadministration of DGAT2i + ACCi, compared to placebo, and the coadministration of DGAT2i + ACCi relative to DGAT2i alone.;Primary end point(s): Proportion of participants achieving resolution of NASH without worsening of fibrosis or improvement in fibrosis by =1 stage without worsening of NASH or both, based on assessment by sponsor-identified central pathologist(s), ;Timepoint(s) of evaluation of this end point: at Week 48Secondary end point(s): 1. Percent change in liver fat (assessed via MRI-PDFF in substudy population)<br>2. Proportion of participants achieving improvement in different responder definitions based on assessment by sponsor-identified central pathologist(s) at Week 48 ?€?<br>- Resolution of NASH, without worsening of fibrosis<br>- Improvement in fibrosis by =1 stage, without worsening of NASH<br>- Improvement in fibrosis by =2 stages, without worsening of NASH<br>- Improvement of =2 points in Total NAS<br>3. Assessment of TEAEs, safety related clinical laboratory tests, vital signs, and 12-lead ECGs;Timepoint(s) of evaluation of this end point: 1,2. at Week 48<br>3. over time up to Week 48
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| Sponsor/Collaborators: |
Pfizer Inc.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
350
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 7
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| Start Date: |
01/06/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
7 February 2022
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| Locations: |
United States;Taiwan;Hong Kong;Slovakia;Puerto Rico;Canada;Poland;Bulgaria;Japan;China;Korea, Republic of;India
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004775-39
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