NCT06937203

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	ARO-ALK7	SC injection
DRUG	Placebo	calculated volume to match active treatment by SC injection

Timeline

• Start date: 2025-05-09
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-04-22
• Last updated: 2026-04-13

Locations

8 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study