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ACC inhibitor

PF-06865571 for Non-alcoholic Fatty Liver Disease

Hunan Provincial People's Hospital, Changsha, China
Targeting 2 different conditionsPF-06865571 +2 morePhase 2Waitlist AvailableResearch Sponsored by Pfizer

Study Summary

This trial is testing two new drugs to see if they can improve non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You must have a body mass index (BMI) of 22.5 kg/m2 or higher.
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Your body mass index (BMI) should be equal to or greater than 22.5kg/m2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1>/= or both
Secondary outcome measures
Percent change in liver fat
Proportion of participants achieving Resolution of NASH, without worsening of fibrosis
Proportion of participants achieving improvement in fibrosis by ≥1stage, without worsening of NASH
+6 more

Side effects data

From 2022 Phase 2 trial • 75 Patients • NCT04399538
11%
Diarrhoea
6%
Thrombocytopenia
6%
Cytokeratin 18 increased
6%
Hypertriglyceridaemia
6%
Alanine aminotransferase increased
6%
Vomiting
6%
Type 2 diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06865571 300 mg QD + PF-05221304 20 mg QD
Placebo
PF-06865571 25 mg BID + PF-05221304 10 mg BID
PF-06865571 100 mg BID + PF-05221304 10 mg BID
PF-06865571 300 mg BID + PF-05221304 10 mg BID

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)Experimental Treatment2 Interventions
participants will receive medication for 48 weeks
Group II: PF-06865571 75 mg BIDExperimental Treatment1 Intervention
participants will receive medication for 48 weeks
Group III: PF-06865571 300 mg BIDExperimental Treatment1 Intervention
participants will receive medication for 48 weeks
Group IV: PF-06865571 25 milligrams (mg) twice daily (BID)Experimental Treatment1 Intervention
participants will receive medication for 48 weeks
Group V: PF-06865571 150 mg BIDExperimental Treatment1 Intervention
participants will receive medication for 48 weeks
Group VI: PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)Experimental Treatment2 Interventions
participants will receive medication for 48 weeks
Group VII: PlaceboPlacebo Group1 Intervention
participants will receive medication for 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-05221304
2016
Completed Phase 2
~520
PF-06865571
2018
Completed Phase 2
~220

Find a site

Who is running the clinical trial?

PfizerLead Sponsor
4,459 Previous Clinical Trials
26,143,613 Total Patients Enrolled
16 Trials studying Non-alcoholic Fatty Liver Disease
2,057 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Pfizer CT.gov Call CenterStudy Director
Pfizer
3,395 Previous Clinical Trials
23,420,154 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
781 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

PF-05221304 (ACC inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04321031 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, PF-06865571 75 mg BID, PF-06865571 25 milligrams (mg) twice daily (BID), PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID), PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID), PF-06865571 300 mg BID, PF-06865571 150 mg BID
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: PF-05221304 Highlights & Side Effects. Trial Name: NCT04321031 — Phase 2
PF-05221304 (ACC inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04321031 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the regulatory agency cleared PF-06865571 for use?

"Given the Phase 2 state of this drug, there is evidence that it is safe but no indication yet as to its efficacy. Therefore, our team has assigned a score of two out of three in terms of safety."

Answered by AI

Does the criteria for entry into this research include individuals aged twenty or younger?

"This study is open to any patients aged 18-75. Patients under the age of 18 can take part in 107 other trials and those over 65 have access to 685 different studies."

Answered by AI

Is this medical research recruiting participants at the present time?

"This clinical investigation is not presently recruiting participants, as evident on the information posted in clinicaltrials.gov from June 15th 2020 to November 17th 2022. However, there are currently 766 other medical studies that are looking for volunteers at this exact moment."

Answered by AI

Is it possible to become a participant in this experimental investigation?

"To partake in this trial, participants must have fibrosis and range between 18-75 years old. Currently, an estimated 231 persons are taking part."

Answered by AI

Are there any research centers carrying out this experiment in North America?

"This medical trial is enrolling a total of 100 patients, some from MUSC Investigational Drug Pharmacy in Charleston, TGH Imaging Powered by Tower Radiology Center (MRI) in Oldsmar and Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital in New York. There are many other participating clinical sites as well."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Tennessee
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
Stanford Hospital and Clinics
Vascular and Interventional Specialists of Florida (Liver Biopsy)
Beth Israel Deaconess Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

How responsive is this trial?

Typically responds via
Email
Recent research and studies
BMJ OpenJournal
Efficacy and Safety of an Orally Administered DGAT2 Inhibitor Alone or Coadministered with a Liver-targeted ACC Inhibitor in Adults with Non-alcoholic Steatohepatitis (NASH): Rationale and Design of the Phase II, Dose-ranging, Dose-finding, Randomised, Placebo-controlled MIRNA (metabolic Interventions to Resolve NASH with Fibrosis) Study
Amin, Neeta B, Amanda Darekar, Quentin M Anstee, Vincent Wai-Sun Wong, Frank Tacke, Manoli Vourvahis, Douglas S Lee, et al.. 2022. “Efficacy and Safety of an Orally Administered DGAT2 Inhibitor Alone or Coadministered with a Liver-targeted ACC Inhibitor in Adults with Non-alcoholic Steatohepatitis (NASH): Rationale and Design of the Phase II, Dose-ranging, Dose-finding, Randomised, Placebo-controlled MIRNA (metabolic Interventions to Resolve NASH with Fibrosis) Study”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-056159.
clinicaltrials.govStudy
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
2020. "Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04321031.
~24 spots leftby Jan 2024
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