A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

NCT06937203 · Recruiting

Last updated 2026-05-28

This clinical trial tests the safety of a new experimental drug called ARO-ALK7 in adults who have obesity, with or without type 2 diabetes.

Status Recruiting Currently enrolling participants.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 138 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2025-05 · est. completion 2026-10

Where 8 sites · Australia, New Zealand

What this study is testing ClinicalTrials.gov NCT06937203 ↗

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-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).

Treatments tested

ARO-ALK7 Drug

SC injection
Placebo also known as 0.9% NaCL Drug

calculated volume to match active treatment by SC injection

Main thing measured	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Sponsor	Arrowhead Pharmaceuticals
Conditions studied	Obesity, Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06937203 ↗