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RECRUITING
NCT06700538
PHASE1/PHASE2

A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

ARO-INHBE

Subcutaneous (SC) injection

DRUG

Placebo

Calculated volume to match active treatment by SC injection

DRUG

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