RecruitingPhase 1Phase 2NCT06937203

A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

A Phase 1/2A Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus


Sponsor

Arrowhead Pharmaceuticals

Enrollment

138 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injectable medication called ARO-ALK7 as a potential treatment for obesity, with or without type 2 diabetes. ARO-ALK7 works by silencing a gene involved in fat storage. This is an early-phase trial focused on safety and how the drug behaves in the body. **You may be eligible if...** - You are an adult with obesity (BMI between 30 and 50) - You weigh under 159 kg (350 lbs) - You have tried and failed to lose weight through lifestyle changes at least once - You have no major health conditions that could affect your safety or study results **You may NOT be eligible if...** - Your weight has changed by more than 5% in the last 3 months - You have used GLP-1 medications (like semaglutide or liraglutide) in the past 6 months - You have used other prescription or over-the-counter weight loss medications recently - You have had weight loss surgery or a device-based obesity treatment before - Your obesity is mainly caused by medications or a hormonal/genetic condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGARO-ALK7

SC injection

DRUGPlacebo

calculated volume to match active treatment by SC injection


Locations(8)

Research Site 8

Morayfield, QLC, Australia

Research Site 7

Nedlands, Western Australia, Australia

Research Site 5

Grafton, Auckland, New Zealand

Research Site 6

Papatoetoe, Auckland, New Zealand

Research Site 3

Takapuna, Auckland, New Zealand

Research Site 1

Auckland, New Zealand

Research Site 2

Christchurch, New Zealand

Research Site 4

Rotorua, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06937203


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