Status:
RECRUITING
Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Obesity
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult volunteers with obesity without Type 2 Diabetes Mel...
Eligibility Criteria
Inclusion
- Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs)
- At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
- No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results
- Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later
Exclusion
- Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening
- Use of GLP-1RAs (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
- Use of non-GLP-1R medications for weight loss within 3 months prior to Screening including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate and other prescription or over-the-counter medication or supplement taken for weight loss purposes
- Obesity attributable primarily to medication use, endocrinologic or monogenic disorders
- History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures)
- Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening
- Type 1 diabetes mellitus
- Note: Additional inclusion/exclusion criteria may apply per protocol
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06937203
Start Date
May 7 2025
End Date
July 1 2026
Last Update
December 16 2025
Active Locations (8)
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1
Research Site 8
Morayfield, QLC, Australia, 4506
2
Research Site 7
Nedlands, Western Australia, Australia, 6009
3
Research Site 5
Grafton, Auckland, New Zealand, 1010
4
Research Site 6
Papatoetoe, Auckland, New Zealand, 2025