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ARO-INHBE

Phase 1

Obesity | Small molecule | Metabolic |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jun 26, 2026

Success Probability
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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 Sites5

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:New Zealand
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Recent Changes (Last 90 Days)
LOWJun 26, 2026NCT06700538lastUpdatePostDate: changed
LOWJun 26, 2026NCT06700538lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT06700538Enrollment: 120 → 180
LOWMay 24, 2026NCT06700538studyFirstPostDate: changed