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ARO-ALK7

Phase 1

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

ARO-ALK7 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2025

ARO-ALK7 target and mechanism

Molecular targetALK7
ModalitySmall molecule

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

ARO-ALK7 clinical trials

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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Frequently asked questions about ARO-ALK7

What is ARO-ALK7 used for?

ARO-ALK7 is an investigational drug 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.

What does ARO-ALK7 target?

ARO-ALK7 targets ALK7, a molecular target involved in metabolic regulation. By targeting ALK7, the drug aims to address obesity and related metabolic conditions. The specific mechanism of action is under investigation in clinical trials.

Who is developing ARO-ALK7?

ARO-ALK7 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company. Arrowhead is conducting clinical trials to evaluate the safety and efficacy of ARO-ALK7 in adults with obesity.

What phase is ARO-ALK7 in?

ARO-ALK7 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial is currently recruiting participants to assess the drug's safety and tolerability.

What clinical trials is ARO-ALK7 in?

ARO-ALK7 is being studied in a Phase 1 first-in-human trial with the identifier NCT06937203. The trial is recruiting 150 adults with obesity, with or without type 2 diabetes, at sites in Australia and New Zealand. It is a randomized, double-blind, placebo-controlled study.

Is ARO-ALK7 the same as any other drug?

ARO-ALK7 is a distinct investigational drug candidate developed by Arrowhead Pharmaceuticals. It is not known to be the same as any other approved or marketed medication. Its unique molecular target and development program differentiate it from other obesity treatments.