What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lifestyle modifications, medications like pioglitazone and vitamin E, and investigational agents such as DGAT2 inhibitors and ACC inhibitors. Known side effects of pioglitazone include weight gain, edema, and an increased risk of bone fractures. Vitamin E can cause gastrointestinal issues and, in high doses, an increased risk of hemorrhagic stroke. For investigational agents like DGAT2 inhibitors and ACC inhibitors, specific side effects are still being studied, but potential concerns may include gastrointestinal disturbances and metabolic effects. It is important to discuss these treatments and their side effects with a healthcare provider.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or Non-alcoholic Steatohepatitis (NASH). However, investigational agents like PF-06865571 (DGAT2 inhibitor) and PF-05221304 (ACC inhibitor) are being studied for their potential to treat these conditions. These agents target metabolic pathways involved in lipid synthesis and storage, which are crucial in the pathogenesis of NAFLD and NASH. Other investigational treatments include obeticholic acid, a bile acid derivative that has shown promise in improving liver fibrosis in NASH patients.

What other types of research exist?

Promising novel alternatives for NAFLD treatment in 2024 include CPL207280, a GPR40/FFA1-specific agonist, and BR103354, a FAP inhibitor. Both have shown potential in treating metabolic conditions related to NAFLD.

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ACC inhibitor

Dual Drug Therapy for NASH with Fibrosis (MIRNA Trial)

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition

Be older than 18 years old

Must not have

Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis

Unstable concomitant medical conditions, based on medical history or screening laboratory results including unstable liver function tests, recent cardiovascular event(s), significant malignancies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

Summary

This trial is testing a new drug called PF-06865571 alone and with another drug, PF-05221304, on patients with NASH or liver fibrosis. The drugs aim to improve liver health by blocking enzymes that produce and store fat in the liver.

Who is the study for?

This trial is for adults with a liver condition called NASH and fibrosis stages F2 or F3. Participants must have a BMI of at least 22.5 kg/m2. It's not suitable for those with unstable health conditions, other liver diseases like alcoholic steatohepatitis, cirrhosis, active hepatitis, or any issue that affects drug absorption.

What is being tested?

The MIRNA study tests two oral drugs: PF-06865571 alone and combined with PF-05221304 to see if they can resolve NASH or improve liver fibrosis. The effectiveness will be measured through changes observed in liver biopsies.

What are the potential side effects?

Potential side effects may include digestive issues due to the drugs' action on the liver and metabolism. Since these are investigational treatments, there could also be unknown risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver condition is confirmed as NASH with moderate to severe scarring.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have liver conditions like alcoholic liver disease, cirrhosis, or active hepatitis.

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I do not have any unstable health conditions like heart issues or liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Resolution of NASH without worsening of fibrosis or improvement in fibrosis by 1>/= or both

Secondary study objectives

Percent change in liver fat

Side effects data

From 2022 Phase 2 trial • 75 Patients • NCT04399538

11%

Diarrhoea

Thrombocytopenia

Cytokeratin 18 increased

Hypertriglyceridaemia

Alanine aminotransferase increased

Vomiting

Type 2 diabetes mellitus

100%

80%

60%

40%

20%

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