What is ARO-ALK7 studying for obesity with and without Type 2 Diabetes?

This clinical trial is studying ARO-ALK7 to evaluate its safety, how it is processed by the body, and its effects in adults with obesity, including those with and without Type 2 Diabetes. The study also looks at ARO-ALK7 alone and in combination with tirzepatide. Arrowhead Pharmaceuticals is leading this research to improve understanding of treatments for obesity.

Who may be eligible for this obesity clinical trial?

Adults aged 18 to 65 years with a BMI between 30 and 50 may be eligible. Participants should have tried but not succeeded in losing weight through lifestyle changes. People with certain recent weight changes or recent use of specific weight loss medications may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered during the trial.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 65Years

All Genders

ID06937203

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

Led by Arrowhead Pharmaceuticals · Updated on 2026-07-08

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 65 years
Obesity with a body mass index (BMI) between 30 and 50 kg/m2, and weight not exceeding 159 kg (350 lbs) at screening
At least one self-reported unsuccessful attempt at weight loss with lifestyle modification
No abnormal findings at screening that may affect safety or study results
Female participants of childbearing potential must agree to use highly effective contraception
Male participants with female partners of childbearing potential must agree to use condoms during the study and for at least 90 days after the study or last dose
Participants must not donate sperm or eggs during the study and for at least 90 days after the study or last dose

You will not qualify if you...

Weight gain or loss greater than 5% within 3 months prior to screening
Use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) within 6 months prior to screening
Use of non-GLP-1R weight loss medications within 3 months prior to screening, including naltrexone/bupropion, orlistat, phentermine/topiramate, or supplements
Obesity mainly caused by medication, monogenic or endocrinologic disorders (except polycystic ovary syndrome)
History of surgical or device-based therapy for obesity
Use of medications or therapies known to cause weight gain or body composition changes within 3 months prior to screening
Type 1 diabetes mellitus
Additional criteria may apply per protocol

Research Team

Medical Monitor

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