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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
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
ARO-INHBE
Subcutaneous (SC) injection
Placebo
Calculated volume to match active treatment by SC injection
Tirzepatide
SC injection
Locations (15)
Research Site
Camberwell, Australia
Research Site
Charlestown, Australia
Research Site
Maroochydore, Australia
Research Site
Sydney, Australia
Research Site
Chicoutimi, Canada
Research Site
Concord, Canada
Research Site
Toronto, Canada
Research Site
Tbilisi, Georgia
Research Site 2
Tbilisi, Georgia
Research Site
Tbilisi, Georgia
Research Site
Tbilisi, Georgia
Research Site
Grafton, Auckland, New Zealand
Research Site
Auckland, New Zealand
Research Site
Auckland, New Zealand
Research Site
Christchurch, New Zealand