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ARO-ALK7

Phase 1

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

Success Probability

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Market & Valuation

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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
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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
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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
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Recent Changes (Last 90 Days)

MEDIUMJul 8, 2026NCT06937203Enrollment: 138 → 150
MEDIUMJul 8, 2026NCT06937203Enrollment: 138 → 150

Frequently asked questions about ARO-ALK7

What is ARO-ALK7 used for?

ARO-ALK7 is an investigational small molecule being developed for the treatment of obesity. It is also being studied in adults with obesity who have type 2 diabetes mellitus. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ARO-ALK7?

ARO-ALK7 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR. The company is conducting a first-in-human study of the drug in adults with obesity, with and without type 2 diabetes.

What phase is ARO-ALK7 in?

ARO-ALK7 is in Phase 1 clinical development. It is currently being evaluated in a first-in-human study that is recruiting participants. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of obesity.

What clinical trials is ARO-ALK7 in?

ARO-ALK7 is being studied in a Phase 1 clinical trial with the identifier NCT06937203. This is a first-in-human, randomized, double-blind, placebo-controlled study in adults with obesity, with and without type 2 diabetes mellitus. The trial is recruiting participants in Australia and New Zealand and aims to enroll 150 people.

How does ARO-ALK7 work?

ARO-ALK7 is a small molecule designed to target the activin receptor-like kinase 7 (ALK7) pathway, which is involved in metabolic regulation. By modulating this pathway, the drug aims to address obesity. However, the specific mechanism of action has not been fully detailed in available information.