Phase 12a Study Evaluating Safety and Effects of ARO-ALK7 in Adults With Obesity, With or Without Type 2 Diabetes

What this Trial Is About

Researchers are evaluating ARO-ALK7, a drug given by injection, in adult participants with obesity, both with and without Type 2 Diabetes Mellitus T2DM. This Phase 12a study aims to understand the safety, tolerability, how the body processes the drug, and how the drug affects the body. The study is divided into two parts Part 1 focuses on adults with obesity without T2DM, and Part 2 includes adults with obesity both with and without T2DM, testing ARO-ALK7 alone or combined with tirzepatide. Participants receive either single or multiple doses of ARO-ALK7 or matching placebo injections. In Part 2, some participants also receive weekly tirzepatide starting from Day 15 through Day 253. The doses of ARO-ALK7 are escalated to explore different levels of the drug. The study compares ARO-ALK7 alone, placebo, ARO-ALK7 combined with tirzepatide, and placebo combined with tirzepatide to assess their effects. During the study, participants are monitored for treatment-emergent adverse events until Day 253. Researchers collect detailed information on how the drug moves and acts in the body, especially during Part 1. Participants will have scheduled visits to receive treatments and undergo safety and effectiveness assessments. The total study duration covers up to about 8 and a half months, including dosing and follow-up, to fully evaluate the drugs impact and safety profile.

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