NCT07223203 TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy
| NCT ID | NCT07223203 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alnylam Pharmaceuticals |
| Condition | Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2027-12-27 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 125 participants in total. It began in 2026-02-03 with a primary completion date of 2027-12-27.
⚠ 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
The purpose of this study is to: * Determine the efficacy of nucresiran in patients with hATTR-PN by evaluating the effect on neurologic impairment, quality of life, nutritional status, disability, and gait speed * Demonstrate superiority of nucresiran compared to in-study vutrisiran with respect to serum transthyretin (TTR) levels
Eligibility Criteria
Inclusion Criteria: * Has documented diagnosis of hATTR-PN * Has a diagnosis of hATTR amyloidosis with polyneuropathy with a documented TTR gene variant * Has a neuropathy impairment score (NIS) of 5 to 130 (inclusive) * Has a Karnofsky Performance Status (KPS) of ≥60% Exclusion Criteria: * Has had a liver transplant or is likely, in the opinion of the Investigator, to undergo liver transplantation during the Treatment Period of the study * Has known other (non-hATTR) forms of amyloidosis or clinical evidence of leptomeningeal amyloidosis * Has a New York Heart Association (NYHA) heart failure classification \>2 * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 upper limit of normal (ULN) * Has total bilirubin \>1.5 ULN * Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m\^2 * Has other known causes of sensorimotor or autonomic neuropathy
Contact & Investigator
Medical Director
STUDY DIRECTOR
Alnylam Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07223203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy. 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 NCT07223203 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 125 participants.
Is NCT07223203 currently recruiting?
Yes, NCT07223203 is actively recruiting participants. Contact the research team at clinicaltrials@alnylam.com for enrollment information.
Where is the NCT07223203 trial being conducted?
This trial is being conducted at Aurora, United States, Chicago, United States, Baltimore, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT07223203 clinical trial?
NCT07223203 is sponsored by Alnylam Pharmaceuticals. The principal investigator is Medical Director at Alnylam Pharmaceuticals. The trial plans to enroll 125 participants.