Metabolic Dysfunction-Associated SteatohepatitisPhase 2NCT07859813
A Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis
A Phase 2 study testing ARO-INHBE in people with Metabolic Dysfunction-Associated Steatohepatitis, run by Arrowhead Pharmaceuticals.
Trial summary
This study is designed to evaluate the safety and efficacy of ARO-INHBE in adults with suspected metabolic dysfunction-associated steatohepatitis (MASH). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- ARO-INHBE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Being tested
- ARO-INHBE, Placebo
- Keywords
- MASH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-INHBEDrug
Subcutaneous (SC) injection
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| ARO-INHBE Low Dose | Experimental | Participants will receive ARO-INHBE at a low dose on Days 1, 85, 169, and 253. Receives: Drug: ARO-INHBE |
| Placebo for ARO-INHBE Low Dose | Placebo comparator | Participants will receive placebo on Days 1, 85, 169, and 253. Receives: Drug: Placebo |
| ARO-INHBE High Dose (Schedule 1) | Experimental | Participants will receive ARO-INHBE at a high dose on Days 1, 85, 169, and 253. Receives: Drug: ARO-INHBE |
| Placebo for ARO-INHBE High Dose (Schedule 1) | Placebo comparator | Participants will receive placebo on Days 1, 85, 169, and 253. Receives: Drug: Placebo |
| ARO-INHBE High Dose (Schedule 2) | Experimental | Participants will receive ARO-INHBE at a high dose on Days 1, 85, and 169. Receives: Drug: ARO-INHBE |
| Placebo for ARO-INHBE High Dose (Schedule 2) | Experimental | Participants will receive placebo on Days 1, 85, and 169. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 48
Measured: Baseline, Week 48
Secondary outcomes (13)
Percentage of Participants With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis (Histology)
Measured: Week 48
Percentage of Participants With Improvement in Liver Fibrosis by ≥1 Stage and No Worsening of Steatohepatitis (Histology)
Measured: 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
Measured: Baseline, Week 48
Change From Baseline in Fibrosis Stage (Histology) at Week 48
Measured: Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to Week 48
Change From Baseline in LFC by MRI-PDFF at Week 24
Measured: 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
Measured: Week 24 and Week 48
Change From Baseline Through Week 48 in Body Weight
Measured: 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)
Measured: Baseline through Week 48
Change From Baseline Through Week 48 in Serum Activin E Protein
Measured: Baseline through Week 48
Change From Baseline in Markers of Hepatic Steatosis at Week 48
Measured: Baseline through Week 48
Change From Baseline in Markers of Inflammation at Week 48
Measured: Baseline through Week 48
Change From Baseline in Markers of Fibrosis at Week 48
Measured: Baseline through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859813
- Sponsor's protocol ID
- AROINHBE-2001
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07859813
- Acronym / sponsor ID
- AROINHBE-2001
- Keywords
- MASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and efficacy of ARO-INHBE in adults with suspected metabolic dysfunction-associated steatohepatitis (MASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ARO-INHBE Low Dose | Experimental | Drug: ARO-INHBEParticipants will receive ARO-INHBE at a low dose on Days 1, 85, 169, and 253. |
| Placebo for ARO-INHBE Low Dose | Placebo comparator | Drug: PlaceboParticipants will receive placebo on Days 1, 85, 169, and 253. |
| ARO-INHBE High Dose (Schedule 1) | Experimental | Drug: ARO-INHBEParticipants will receive ARO-INHBE at a high dose on Days 1, 85, 169, and 253. |
| Placebo for ARO-INHBE High Dose (Schedule 1) | Placebo comparator | Drug: PlaceboParticipants will receive placebo on Days 1, 85, 169, and 253. |
| ARO-INHBE High Dose (Schedule 2) | Experimental | Drug: ARO-INHBEParticipants will receive ARO-INHBE at a high dose on Days 1, 85, and 169. |
| Placebo for ARO-INHBE High Dose (Schedule 2) | Experimental | Drug: PlaceboParticipants will receive placebo on Days 1, 85, and 169. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARO-INHBESubcutaneous (SC) injection | Drug | ARO-INHBE High Dose (Schedule 1), ARO-INHBE High Dose (Schedule 2), ARO-INHBE Low Dose |
| PlaceboSC injection | Drug | Placebo for ARO-INHBE High Dose (Schedule 1), Placebo for ARO-INHBE High Dose (Schedule 2), Placebo for ARO-INHBE Low Dose |
Primary outcome
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
13 secondary outcomes
Percentage of Participants With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis (Histology)
Time frame: Week 48
Percentage of Participants With Improvement in Liver Fibrosis by ≥1 Stage and No Worsening of Steatohepatitis (Histology)
Time frame: 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
Change From Baseline in Fibrosis Stage (Histology) at Week 48
Time frame: Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 48
Change From Baseline in LFC by MRI-PDFF at Week 24
Time frame: 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
Change From Baseline Through Week 48 in Body Weight
Time frame: 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
Change From Baseline Through Week 48 in Serum Activin E Protein
Time frame: Baseline through Week 48
Change From Baseline in Markers of Hepatic Steatosis at Week 48
Time frame: Baseline through Week 48
Change From Baseline in Markers of Inflammation at Week 48
Time frame: Baseline through Week 48
Change From Baseline in Markers of Fibrosis at Week 48
Time frame: Baseline through Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARO-INHBE in people with Metabolic Dysfunction-Associated Steatohepatitis, run by Arrowhead Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (626-304-3400, AROINHBE@arrowheadpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.