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A First-In-Human Study of ARO-INHBE 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-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).
Official title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-INHBE in Adult Volunteers With Obesity With and Without Diabetes Mellitus
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-12-04
Completion Date
2028-01-17
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
ARO-INHBE
Subcutaneous (SC) injection
Placebo
Calculated volume to match active treatment by SC injection
Tirzepatide
SC injection
Locations (3)
Research Site 1
Grafton, Auckland, New Zealand
Research Site 3
Auckland, New Zealand
Research Site 2
Christchurch, New Zealand