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ARO-INHBE

Phase 1

Obesity | Small molecule | Metabolic |Arrowhead Pharmaceuticals, Inc.|Last Updated: Aug 18, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

ARO-INHBE · 1 trial · 1 indication

Phase 1 1
NCT06700538A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes MellitusObesity
RECRUITING180 Analytics
PHASE1RECRUITING
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to Day 365

Secondary Endpoints

PK of ARO-INHBE: Maximum observed Plasma Concentration (Cmax)
Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29): Through 48 hours post first and second dose; Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Time to Maximum Observed Plasma Concentration (Tmax)
Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
PK of ARO-INHBE: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Part 1: single dose (Day 1): Through 48 hours post-dose; Part 1: multiple dose (Day 1, Day 29); Part 3: multiple dose (Day 1, Day 85): Through 48 hours post first and second dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: ARO-INHBEEXPERIMENTALARO-INHBE in single (Day 1) or multiple (Days 1 and 29) ascending doses
Part 1: PlaceboPLACEBO_COMPARATORPlacebo in single (Day 1) or multiple (Days 1 and 29) matching doses
Part 2: ARO-INHBE + TirzepatideEXPERIMENTALARO-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 + TirzepatidePLACEBO_COMPARATORPlacebo 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-INHBEEXPERIMENTALARO-INHBE on Days 1, 85, 169, and 253
Part 3: PlaceboPLACEBO_COMPARATORPlacebo doses on Days 1, 85, 169, and 253
Part 3: ARO-INHBE + TirzepatideEXPERIMENTALARO-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 + TirzepatidePLACEBO_COMPARATORPlacebo 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

Interventions

NameTypeDescription
ARO-INHBEDRUGSubcutaneous (SC) injection
PlaceboDRUGCalculated volume to match active treatment by SC injection
TirzepatideDRUGSC injection
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Obesity, defined as Body Mass Index (BMI) between 30 to 50 kilograms (kg)/square meter (m\^2) at Screening * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * Type 2 diabetes mellitus for at least 6 months prior to Screening, with gl...

Countries:AustraliaNew Zealand
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Recent Changes (Last 90 Days)

LOWAug 19, 2026NCT06700538lastUpdatePostDate: changed
LOWAug 19, 2026NCT06700538lastUpdatePostDate: changed
LOWAug 19, 2026NCT06700538lastUpdatePostDate: changed
LOWJun 26, 2026NCT06700538lastUpdatePostDate: changed
LOWJun 26, 2026NCT06700538lastUpdatePostDate: changed

Frequently asked questions about ARO-INHBE

What is ARO-INHBE used for?

ARO-INHBE is an investigational drug being developed for the treatment of obesity. It is currently in Phase 1 clinical development and is being studied in adults with obesity, with and without type 2 diabetes mellitus.

Who makes ARO-INHBE?

ARO-INHBE is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR.

What phase is ARO-INHBE in?

ARO-INHBE is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A first-in-human study is currently recruiting participants.

What clinical trials is ARO-INHBE in?

ARO-INHBE is being evaluated in a Phase 1 clinical trial with the identifier NCT06700538. This is a first-in-human study in adults with obesity, with and without type 2 diabetes mellitus, and is currently recruiting participants in Australia and New Zealand.

Is ARO-INHBE a small molecule?

Yes, ARO-INHBE is a small molecule therapeutic. It is being developed as a treatment for obesity and is currently in Phase 1 clinical trials.