A Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis

September 30, 2026 updated by: Arrowhead Pharmaceuticals

A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis With or Without Type 2 Diabetes Mellitus

This study is designed to evaluate the safety and efficacy of ARO-INHBE in adults with suspected metabolic dysfunction-associated steatohepatitis (MASH).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • BMI between 30.0 to 50.0 kilograms (kg)/square meter (m^2) (inclusive) with body weight ≤159 kg at Screening
  • Stable body weight
  • Participants on background glucagon-like peptide-1 (GLP-1) (or GLP-1/glucose-dependent insulinotropic polypeptide [GIP]) therapy must be on a stable dose for ≥6 months
  • Participants not on GLP-1 (or GLP-1/GIP) therapy must be treatment naïve or off therapy for ≥6 months.

Key Exclusion Criteria:

  • Clinical or laboratory signs of decompensated liver disease, history of esophageal varices, ascites, or hepatic encephalopathy, or history of cirrhosis on biopsy performed prior to Screening.
  • History or evidence of hepatic disease of non-metabolic dysfunction-associated steatotic liver disease (MASLD) etiology (viral hepatitis, alcoholic liver disease, primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], Wilson's disease, alpha-1 antitrypsin [A1AT] deficiency, hemochromatosis, or autoimmune hepatitis).
  • Type 1 diabetes mellitus (T1DM) or uncontrolled Type 2 diabetes mellitus (T2DM).
  • Use of non-GLP-1 receptor medications known to cause weight loss within 3 months prior to Screening.
  • Use of medications associated with weight gain (for example, tricyclic antidepressants, mirtazapine, paroxetine, atypical antipsychotics) unless on a stable dose ≥3 months prior to Screening with anticipated continuation on this dose throughout the trial.
  • Clinically significant end-organ disease.
  • Major surgery within 90 days of Screening.
  • Use of hepatocyte-targeted ribonucleic acid interference (RNAi) therapies within 6 months of Screening.
  • Insulin use within 6 months of Screening (except short-term peri-procedural/inpatient use).

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARO-INHBE Low Dose

Participants will receive ARO-INHBE at a low dose on Days 1, 85, 169, and 253.
Drug: ARO-INHBE

Subcutaneous (SC) injection
Placebo Comparator: Placebo for ARO-INHBE Low Dose

Participants will receive placebo on Days 1, 85, 169, and 253.
Drug: Placebo

SC injection
Experimental: ARO-INHBE High Dose (Schedule 1)

Participants will receive ARO-INHBE at a high dose on Days 1, 85, 169, and 253.
Drug: ARO-INHBE

Subcutaneous (SC) injection
Placebo Comparator: Placebo for ARO-INHBE High Dose (Schedule 1)

Participants will receive placebo on Days 1, 85, 169, and 253.
Drug: Placebo

SC injection
Experimental: ARO-INHBE High Dose (Schedule 2)

Participants will receive ARO-INHBE at a high dose on Days 1, 85, and 169.
Drug: ARO-INHBE

Subcutaneous (SC) injection
Experimental: Placebo for ARO-INHBE High Dose (Schedule 2)

Participants will receive placebo on Days 1, 85, and 169.
Drug: Placebo

SC injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 48
Time Frame: Baseline, Week 48
Baseline, Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis (Histology)
Time Frame: Week 48
Week 48
Percentage of Participants With Improvement in Liver Fibrosis by ≥1 Stage and No Worsening of Steatohepatitis (Histology)
Time Frame: Week 48
Week 48
Change From Baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) Total Score and Individual Subscores (Steatosis, Hepatocyte Ballooning, and Lobular Inflammation) at Week 48
Time Frame: Baseline, Week 48
Baseline, Week 48
Change From Baseline in Fibrosis Stage (Histology) at Week 48
Time Frame: Baseline, Week 48
Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Week 48
Baseline up to Week 48
Change From Baseline in LFC by MRI-PDFF at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage of Participants With >30%, >50%, and >70% Reduction in LFC From Baseline by MRI-PDFF at Week 24 and Week 48
Time Frame: Week 24 and Week 48
Week 24 and Week 48
Change From Baseline Through Week 48 in Body Weight
Time Frame: Baseline through Week 48
Baseline through Week 48
Change From Baseline Through Week 48 in Body Composition (Total Adipose Tissue [TAT], Visceral Adipose Tissue [VAT] Volume, and Total Lean Tissue [TLT]), by Whole-body Magnetic Resonance Imaging (WB-MRI)
Time Frame: Baseline through Week 48
Baseline through Week 48
Change From Baseline Through Week 48 in Serum Activin E Protein
Time Frame: Baseline through Week 48
Baseline through Week 48
Change From Baseline in Markers of Hepatic Steatosis at Week 48
Time Frame: Baseline through Week 48
Baseline through Week 48
Change From Baseline in Markers of Inflammation at Week 48
Time Frame: Baseline through Week 48
Baseline through Week 48
Change From Baseline in Markers of Fibrosis at Week 48
Time Frame: Baseline through Week 48
Baseline through Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arrowhead Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AROINHBE-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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