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

NCT06700538 · Recruiting

Last updated 2026-05-28

This clinical trial tests a new experimental drug called ARO-INHBE in adults with obesity, including those with and without type 2 diabetes, to evaluate its safety.

Status Recruiting Currently enrolling participants.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 180 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2024-12 · est. completion 2028-01

Where 3 sites · New Zealand

What this study is testing ClinicalTrials.gov NCT06700538 ↗

Description as written by the study sponsor.

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).

Treatments tested

ARO-INHBE Drug

Subcutaneous (SC) injection
Placebo Drug

Calculated volume to match active treatment by SC injection
Tirzepatide Drug

SC injection

Main thing measured	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Sponsor	Arrowhead Pharmaceuticals
Conditions studied	Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06700538 ↗