Trials / Recruiting
RecruitingNCT07223203
TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy
TRITON-PN: A Phase 3, Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy (hATTR-PN)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nucresiran | Nucresiran 300 mg administered SC q6M |
| DRUG | Vutrisiran | Vutrisiran 25 mg administered SC q3M |
Timeline
- Start date
- 2026-01-16
- Primary completion
- 2027-12-27
- Completion
- 2031-06-12
- First posted
- 2025-10-31
- Last updated
- 2026-01-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07223203. Inclusion in this directory is not an endorsement.