Actively Recruiting
A Phase 1/2A Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus
Led by Arrowhead Pharmaceuticals · Updated on 2026-04-13
138
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-ALK7 in adults with obesity, including those with and without Type 2 Diabetes Mellitus (T2DM). The study aims to understand how ARO-ALK7 behaves in the body and its effects, both alone and combined with tirzepatide, a medication used for diabetes and weight management. This research includes adults aged 18 to 65 years who do not have T2DM in the initial phase, expanding to include those with T2DM in later phases.
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
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
- Weight at screening must not exceed 159 kg (350 lbs)
- At least one unsuccessful attempt at weight loss through lifestyle changes
- No abnormal clinical findings 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 greater than 5% within 3 months before screening
- Use of GLP-1 receptor agonists (like liraglutide or semaglutide) within 6 months before screening
- Use of other weight loss medications within 3 months before screening
- Obesity mainly caused by medication, genetic, or endocrine 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
- Diagnosis of type 1 diabetes mellitus
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 36 weeks (Day 1 through Day 253)
Participants receive ARO-ALK7 or placebo by subcutaneous injection on Day 1 and possibly Day 85. Some participants also receive weekly tirzepatide injections from Day 15 through Day 253.
2 dosing visits plus weekly visits for up to 36 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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