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A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Sponsor: Arrowhead Pharmaceuticals
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2025-05-09
Completion Date
2026-10
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
ARO-ALK7
SC injection
Placebo
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