First-in-Human Study of ARO-ALK7 Initiated for Obesity with and without Type 2 Diabetes Mellitus

The global burden of obesity and Type 2 Diabetes Mellitus (T2DM) continues to rise, necessitating novel therapeutic strategies beyond current standards of care. Existing treatments, while effective, often have limitations in efficacy, tolerability, or accessibility. Activin receptor-like kinase 7 (ALK7) is a receptor implicated in metabolic regulation, with its inhibition showing promise in preclinical models for improving glucose homeostasis and reducing adiposity. Targeting ALK7 represents a distinct mechanism from established pathways like GLP-1R agonism, offering a potential new avenue for addressing the complex pathophysiology of these interconnected metabolic diseases.

This is a Phase 1/2a double-blind, dose-escalating study evaluating ARO-ALK7. Part 1 focuses on single and multiple doses of ARO-ALK7 in adults with obesity without Type 2 Diabetes Mellitus (T2DM), assessing safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Part 2 evaluates multiple doses of ARO-ALK7 in adults with obesity both with and without T2DM, either as monotherapy or in combination with tirzepatide. The study design aims to characterize the drug's profile across different metabolic states and in combination with a leading GLP-1/GIP agonist.

Results from this Phase 1/2a study of ARO-ALK7 are not yet available. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of ARO-ALK7. The primary objective is to establish the safety profile and initial human PK/PD characteristics of ARO-ALK7 in adults with obesity, with or without Type 2 Diabetes Mellitus, both as a standalone therapy and in combination with tirzepatide.