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

ConditionMetabolic Dysfunction-Associated Steatohepatitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorArrowhead Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI between 30.0 to 50.0 kilograms (kg)/square meter (m²) (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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARO-INHBE

    Drug

    Subcutaneous (SC) injection

  • Placebo

    Drug

    SC injection

Treatment groups

252 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ARO-INHBE Low DoseExperimental treatment 1 intervention
Group B: Placebo for ARO-INHBE Low DosePlacebo comparator 1 intervention
Group C: ARO-INHBE High Dose (Schedule 1)Experimental treatment 1 intervention
Group D: Placebo for ARO-INHBE High Dose (Schedule 1)Placebo comparator 1 intervention
Group E: ARO-INHBE High Dose (Schedule 2)Experimental treatment 1 intervention
Group F: Placebo for ARO-INHBE High Dose (Schedule 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Percentage of Participants With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis (Histology)

Time frame
Week 48
2

Percentage of Participants With Improvement in Liver Fibrosis by ≥1 Stage and No Worsening of Steatohepatitis (Histology)

Time frame
Week 48
3

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
4

Change From Baseline in Fibrosis Stage (Histology) at Week 48

Time frame
Baseline, Week 48

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: