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Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus
Sponsor: Arrowhead Pharmaceuticals
Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult volunteers with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1) and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult volunteers with obesity with and without (T2DM) receiving tirzepatide (Part 2). In Part 1A eligible participants with obesity will be randomized to receive a single dose of ARO-ALK7 or placebo (PBO) administered on Day 1. In Part 1B, eligible participants with obesity will be randomized to receive two doses of ARO-ALK7 or PBO administered on Day 1 and Day 85. In Part 2, eligible subjects with obesity with and without (T2DM) will be randomized to combined therapy with tirzepatide and ARO-ALK7 (intervention arm) or tirzepatide and PBO (control arm). Tirzepatide will be initiated on Day 15 and administered by subcutaneous (SC) injection weekly. ARO-ALK7 or PBO will be administered by SC injection on Day 1 and Day 85. Subjects in both Part 1 and Part 2 will undergo adipose aspiration pre and post dose.
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
126
Start Date
2025-05-07
Completion Date
2026-07
Last Updated
2025-12-16
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