Recent Updates
Recently added Catalysts

ARO-ALK7

Phase 1

Obesity | Small molecule | Metabolic |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jul 8, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical trial landscape

ARO-ALK7 · 1 trial · 2 indications

Phase 1 1
NCT06937203A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes MellitusObesity
RECRUITING150 Analytics
PHASE1RECRUITING
A First-In-Human Study of ARO-ALK7 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 253 End of Study (EOS)
Secondary Endpoints
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Through 48 hours post-dose
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Through 48 hours post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 and Part 2 (optional cohort): ARO-ALK7EXPERIMENTALARO-ALK7 in single (Day 1) or multiple (Days 1 and 85) ascending doses
Part 1 and Part 2 (optional cohort): PlaceboPLACEBO_COMPARATORPlacebo in single (Day 1) or multiple (Days 1 and 85) matching doses
Part:2: ARO-ALK7 + TirzepatideEXPERIMENTALARO-ALK7 at ascending doses on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253
Part 2: Placebo + TirzepatidePLACEBO_COMPARATORPlacebo dose on Days 1 and 85 plus weekly doses of tirzepatide initiated at Day 15 through Day 253
Interventions
NameTypeDescription
ARO-ALK7DRUGSubcutaneous (SC) injection
PlaceboDRUGcalculated volume to match active treatment by SC injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m\^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds \[lbs\]) * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * No abnormal...

Countries:AustraliaNew Zealand
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
MEDIUMJul 8, 2026NCT06937203Enrollment: 138 → 150
MEDIUMJul 8, 2026NCT06937203Enrollment: 138 → 150
MEDIUMMay 26, 2026NCT06937203Enrollment: 126 → 138
LOWMay 24, 2026NCT06937203studyFirstPostDate: changed