First-in-human ARO-ALK7 for adults with obesity, with or without type 2 diabetes
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
PHASE1; PHASE2 · Arrowhead Pharmaceuticals · NCT06937203
This trial will test whether ARO-ALK7 injections are safe and can change weight and metabolic markers in adults with obesity, with or without type 2 diabetes.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Arrowhead Pharmaceuticals (industry) |
| Locations | 8 sites (Morayfield, QLC and 7 other locations) |
| Trial ID | NCT06937203 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2a double-blind, placebo-controlled, dose-escalation trial gives single and multiple doses of ARO-ALK7 to adults with obesity, first in participants without type 2 diabetes (Part 1) and then in participants with and without type 2 diabetes receiving monotherapy or combination therapy with tirzepatide (Part 2). The study’s primary focus is safety and tolerability, with collection of pharmacokinetic and pharmacodynamic data and exploratory measures of weight and metabolic outcomes. Participants are enrolled into escalating dose cohorts with placebo control and blinding to treatment assignment. The design allows early human dosing information and signals of biological effect to guide further development.
Who should consider this trial
Good fit: Adults with BMI 30–50 kg/m2 (weight ≤159 kg) who have tried and not sustained lifestyle-based weight loss and who meet other study criteria, including no GLP-1 receptor agonist use within 6 months, would be the intended participants.
Not a fit: People who recently gained or lost more than 5% body weight in the prior 3 months, those who used GLP-1 receptor agonists within 6 months, individuals outside the BMI/weight limits, and pregnant people are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, ARO-ALK7 could offer a new way to reduce body weight and improve metabolic control, possibly adding benefit when combined with existing drugs like tirzepatide.
How similar studies have performed: ARO-ALK7 is first-in-human so direct human data are not available, although other metabolic drug classes such as GLP-1 receptor agonists have produced substantial weight loss in humans.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Morayfield, QLC and 7 other locations
- Research Site 8 — Morayfield, QLC, Australia (RECRUITING)
- Research Site 7 — Nedlands, Western Australia, Australia (NOT_YET_RECRUITING)
- Research Site 5 — Grafton, Auckland, New Zealand (RECRUITING)
- Research Site 6 — Papatoetoe, Auckland, New Zealand (RECRUITING)
- Research Site 3 — Takapuna, Auckland, New Zealand (RECRUITING)
- Research Site 1 — Auckland, New Zealand (RECRUITING)
- Research Site 2 — Christchurch, New Zealand (RECRUITING)
- Research Site 4 — Rotorua, New Zealand (RECRUITING)
Study contacts
- Study coordinator: Medical Monitor
- Email: AROALK71001@arrowheadpharma.com
- Phone: 626-304-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Diabetes Mellitus, Type 2