Actively Recruiting
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Led by Arrowhead Pharmaceuticals · Updated on 2026-04-24
180
Participants Needed
3
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).
CONDITIONS
Official 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...
- 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 modification
- Type 2 diabetes mellitus for at least 6 months prior to Screening with HgbA1c between 6.0% and 9.5%, on stable diabetes medication for at least 3 months (for select cohorts)
- Willing and able to follow all study assessments, protocol schedule, and maintain a stable diet and exercise routine
- No abnormal clinical findings at Screening that could impact safety or study results
- Participants of childbearing potential must agree to use effective contraception during the study and for 90 days after, 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 GLP1R agonists such as liraglutide or semaglutide within 6 months before Screening
- Use of non-GLP1R weight loss medications within 3 months before Screening
- Obesity caused by medication use, monogenic, 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 before Screening
- Diagnosis of type 1 diabetes mellitus
- History of hyperthyroidism or abnormal thyroid-stimulating hormone levels at Screening
- Evidence of significant end-organ disease
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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