NCT06937203 A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
| NCT ID | NCT06937203 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Arrowhead Pharmaceuticals |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-05-09 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 138 participants in total. It began in 2025-05-09 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 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 Criteria: * 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 in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome) * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06937203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06937203 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06937203 currently recruiting?
Yes, NCT06937203 is actively recruiting participants. Contact the research team at AROALK71001@arrowheadpharma.com for enrollment information.
Where is the NCT06937203 trial being conducted?
This trial is being conducted at Morayfield, Australia, Nedlands, Australia, Grafton, New Zealand, Papatoetoe, New Zealand and 4 additional locations.
Who is sponsoring the NCT06937203 clinical trial?
NCT06937203 is sponsored by Arrowhead Pharmaceuticals. The trial plans to enroll 138 participants.
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