NCT06700538

Study of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 (Part 1), and the safety, tolerability and PD of multiple doses of ARO-INHBE in adult participants with obesity with and without type 2 diabetes mellitus receiving tirzepatide (Part 2).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	ARO-INHBE	SC injection
DRUG	Placebo	calculated volume to match active treatment by SC injection
DRUG	Tirzepatide	SC injection

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-11-22
• Last updated: 2025-12-17

Locations

3 sites across 1 country: New Zealand

Regulatory

• FDA-regulated drug study