Actively Recruiting
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Led by Arrowhead Pharmaceuticals · Updated on 2026-04-13
138
Participants Needed
8
Research Sites
72 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-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).
CONDITIONS
Official Title
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Obesity defined as BMI between 30-50 kg/m2, with weight at screening up to 159 kg (350 lbs)
- At least one unsuccessful attempt at weight loss with lifestyle changes
- No abnormal clinical findings at screening that could affect safety or study results
- Participants of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days after the last dose
- Participants must not donate sperm or eggs during the study and for at least 90 days after the last dose
You will not qualify if you...
- Weight gain or loss of more than 5% within 3 months before screening
- Use of GLP-1 receptor agonists within 6 months before screening
- Use of other weight loss medications within 3 months before screening
- Obesity primarily caused by medication, monogenic or endocrinologic disorders (except polycystic ovary syndrome)
- History of surgical or device-based obesity treatments
- Use of medications associated with weight gain or body composition changes within 3 months before screening
- Type 1 diabetes mellitus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Research Site 8
Morayfield, QLC, Australia, 4506
Actively Recruiting
2
Research Site 7
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
3
Research Site 5
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
4
Research Site 6
Papatoetoe, Auckland, New Zealand, 2025
Actively Recruiting
5
Research Site 3
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
6
Research Site 1
Auckland, New Zealand, 1010
Actively Recruiting
7
Research Site 2
Christchurch, New Zealand, 8011
Actively Recruiting
8
Research Site 4
Rotorua, New Zealand, 3010
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
4
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