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ARO-INHBE · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| ARO-INHBE Low Dose | EXPERIMENTAL | Participants will receive ARO-INHBE at a low dose on Days 1, 85, 169, and 253. |
| Placebo for ARO-INHBE Low Dose | PLACEBO_COMPARATOR | Participants will receive placebo on Days 1, 85, 169, and 253. |
| ARO-INHBE High Dose (Schedule 1) | EXPERIMENTAL | Participants 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 | Participants will receive placebo on Days 1, 85, 169, and 253. |
| ARO-INHBE High Dose (Schedule 2) | EXPERIMENTAL | Participants will receive ARO-INHBE at a high dose on Days 1, 85, and 169. |
| Placebo for ARO-INHBE High Dose (Schedule 2) | EXPERIMENTAL | Participants will receive placebo on Days 1, 85, and 169. |
| Part 1: ARO-INHBE | EXPERIMENTAL | ARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses |
| Part 1: Placebo | PLACEBO_COMPARATOR | Placebo in single (Day 1) or multiple (Days 1 and 29) matching doses |
| Part 2: ARO-INHBE + Tirzepatide | EXPERIMENTAL | ARO-INHBE at ascending doses on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 milligrams \[mg\]) starting Day 15 through Day 169 |
| Part 2: Placebo + Tirzepatide | PLACEBO_COMPARATOR | Placebo dose on Days 1 and 29 plus weekly doses of tirzepatide (2.5 to 5 mg) starting Day 15 through Day 169 |
| Part 3: ARO-INHBE | EXPERIMENTAL | ARO-INHBE on Days 1, 85, 169, and 253 |
| Part 3: Placebo | PLACEBO_COMPARATOR | Placebo doses on Days 1, 85, 169, and 253 |
| Part 3: ARO-INHBE + Tirzepatide | EXPERIMENTAL | ARO-INHBE at ascending doses on Days 1, 85, 169, and 253 plus weekly doses of tirzepatide (2.5 to 15 mg \[or the maximally tolerated dose\]) starting Day 15 through Day 365 |
| Part 3: Placebo + Tirzepatide | PLACEBO_COMPARATOR | Placebo doses on Days 1, 85, 169, and 253 plus weekly doses of tirzepatide (2.5 to 15 mg \[or the maximally tolerated dose\]) starting Day 15 through Day 365 |
| Name | Type | Description |
|---|---|---|
| ARO-INHBE | DRUG | Subcutaneous (SC) injection |
| Placebo | DRUG | SC injection |
| Tirzepatide | DRUG | SC injection |
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 o...
ARO-INHBE is an investigational medicine being developed by Arrowhead Pharmaceuticals for metabolic conditions, specifically metabolic dysfunction-associated steatohepatitis (MASH) and obesity. It is in Phase 2 clinical development and has not been approved by any regulatory agency. It is designed to act on the INHBE target.
ARO-INHBE is being studied for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and obesity. These are the two indications under investigation in its clinical program. Because it remains investigational, it is not currently available as a prescribed treatment outside of clinical trials.
ARO-INHBE targets INHBE. INHBE is the molecular target of the investigational therapy, and Arrowhead Pharmaceuticals is developing the drug around this target for metabolic dysfunction-associated steatohepatitis and obesity. The candidate is in Phase 2 development.
ARO-INHBE is being developed by Arrowhead Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ARWR. The company is the sponsor of the clinical program evaluating the drug in metabolic dysfunction-associated steatohepatitis and obesity.
ARO-INHBE is in Phase 2 clinical development. A Phase 2 trial in adults with metabolic dysfunction-associated steatohepatitis is planned, and a first-in-human Phase 1 study in adults with obesity, with and without type 2 diabetes mellitus, is recruiting. The drug is investigational and has not been approved.
ARO-INHBE is being evaluated in two registered trials. NCT07859813 is a Phase 2 trial in adults with metabolic dysfunction-associated steatohepatitis that is not yet recruiting, with planned enrollment of 252 participants. NCT06700538 is a recruiting Phase 1 first-in-human study in adults with obesity, with and without type 2 diabetes mellitus, enrolling 180 participants in Australia, Canada, Georgia, and New Zealand.