What is ARO-INHBE studying for obesity?

ARO-INHBE is being studied to understand its safety, tolerability, and how it behaves in the body in adults with obesity, with and without type 2 diabetes. Researchers want to see how single and multiple doses work alone or with tirzepatide. This study is sponsored by Arrowhead Pharmaceuticals. Participants can expect to receive injections and undergo regular health checks.

Who may be eligible for this obesity clinical trial?

Adults aged 18 to 65 years with obesity, defined by a BMI between 30 and 50 kg/m², may be eligible. Those with type 2 diabetes for at least 6 months may also qualify if they meet blood sugar criteria and medication stability. Participants must be able to follow the study schedule and use effective contraception if applicable. 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. Personal travel expenses to participate may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 65Years

All Genders

ID06700538

Study of ARO-INHBE Injection in Adults with Obesity, With or Without Type 2 Diabetes, to Evaluate Safety and Effects

Led by Arrowhead Pharmaceuticals · Updated on 2026-06-26

180

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying ARO-INHBE, a drug administered by subcutaneous injection, in adults with obesity, with and without type 2 diabetes. This Phase 12a trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ARO-INHBE. The study includes participants with obesity, defined by a body mass index between 30 and 50 kgm, and those with type 2 diabetes mellitus meeting specific criteria. The study phases explore different dosing regimens and combinations with tirzepatide. The trial has three parts Part 1 assesses single and multiple ascending doses of ARO-INHBE or placebo. Part 2 and Part 3 evaluate multiple doses of ARO-INHBE alone or combined with weekly tirzepatide injections at set dosages, or matching placebos, over periods ranging up to 365 days. Dosing schedules vary by study part and include injections on specific days such as Day 1, 29, 85, 169, 253, and weekly tirzepatide from Day 15 onwards. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events up to Day 365. Pharmacokinetic measurements such as plasma concentration and clearance of ARO-INHBE are taken at various timepoints. Participants are expected to adhere to stable diet and exercise routines and comply with study visits and procedures throughout the study duration. Safety and drug activity are carefully evaluated during and after treatment periods.

CONDITIONS

Brief Title

A First-In-Human Study of ARO-INHBE 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...

Obesity with Body Mass Index (BMI) between 30 to 50 kg/m² at Screening
At least one unsuccessful attempt at weight loss with lifestyle changes
Type 2 diabetes mellitus for at least 6 months with HgbA1c between 6.0% and 9.5%, on stable diabetes medication for at least 3 months (Part 2 and Part 3 only)
Willing and able to follow study assessments and maintain stable diet and exercise
No abnormal clinical findings that could affect safety or study results
Participants of childbearing potential must agree to use effective contraception during and for 90 days after the study and not donate sperm or eggs during this period

You will not qualify if you...

Weight gain or loss greater than 5% within 3 months prior to Screening
Use of glucagon-like protein 1 receptor (GLP1R) agonists within 6 months prior to Screening
Use of other weight loss medications within 3 months prior to Screening
Obesity caused by medication, genetic, or endocrine disorders (except polycystic ovary syndrome)
History of surgical or device-based obesity treatments
Use of medications strongly linked to weight gain within 3 months prior to Screening
Type 1 diabetes mellitus
History of hyperthyroidism or abnormal thyroid-stimulating hormone (TSH) levels at Screening
Clinically significant end-organ disease

Research Team

Medical Monitor

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