Actively Recruiting
A Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-INHBE in Adults With Obesity With and Without Diabetes Mellitus
Led by Arrowhead Pharmaceuticals · Updated on 2026-04-24
180
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ARO-INHBE, a drug being evaluated in adults with obesity, some of whom also have type 2 diabetes. This Phase 1/2a study focuses on assessing the safety, tolerability, and how the drug behaves in the body after single and multiple doses. The study includes adults with obesity, with or without diabetes, to understand how ARO-INHBE works alone or combined with another drug called tirzepatide. Participants receive ARO-INHBE or a placebo through subcutaneous injections following different dosing schedules. In Part 1, single or multiple ascending doses are given on specific days. Part 2 and Part 3 involve ARO-INHBE alone or combined with weekly tirzepatide doses, with administration lasting up to 365 days. Some groups receive matching placebo injections alongside tirzepatide or alone, depending on the study part. During the study, participants undergo regular monitoring for treatment-emergent adverse events up to one year. Researchers collect blood samples to study the drug's behavior and effects on the body over time. Participants follow a stable diet and exercise routine, and contraception use is required for those of childbearing potential. The study evaluates safety and drug levels at multiple timepoints to understand treatment impact and tolerability.
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
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Obesity defined as Body Mass Index (BMI) between 30 to 50 kg/m² at Screening
- At least one self-reported unsuccessful attempt at weight loss with lifestyle changes
- For select groups: diagnosed with type 2 diabetes for at least 6 months, with HgbA1c between 6.0% and 9.5%, on stable diabetes medication for at least 3 months
- Willing and able to follow the study schedule, including stable diet and exercise
- No abnormal clinical findings that could affect safety or study results
- Participants of childbearing potential must agree to use highly effective contraception during and for 90 days after the study, and not donate sperm or eggs during this time
You will not qualify if you...
- Weight gain or loss greater than 5% within 3 months before Screening
- Use of glucagon-like protein 1 receptor (GLP1R) agonists in the 6 months before Screening
- Use of non-GLP1R weight loss medications within 3 months before Screening
- Obesity caused by medication, monogenic, or endocrine disorders other than polycystic ovary syndrome
- History of surgical or device treatment for obesity
- Use of medications strongly associated with weight gain within 3 months before Screening
- Type 1 diabetes mellitus
- History of hyperthyroidism or abnormal thyroid-stimulating hormone (TSH) levels at Screening
- Evidence of serious organ disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks depending on the treatment part and dosing schedule
Participants receive subcutaneous injections of ARO-INHBE, placebo, and/or tirzepatide according to their assigned group, including single and multiple ascending doses and weekly dosing schedules.
Multiple visits for dosing and assessments, including visits on Days 1, 15, 29, 85, 169, 253, and weekly visits for tirzepatide dosing as applicable
Duration - Up to Day 365 after first dose
Participants are monitored for safety and treatment-emergent adverse events after treatment completion.
Visits as scheduled for safety assessments up to one year
Trial Site Locations
Total: 3 locations
1
Research Site 1
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
2
Research Site 3
Auckland, New Zealand, 2025
Actively Recruiting
3
Research Site 2
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
M
Medical Monitor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here