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NCT04042402Phase 3ACTIVE NOT RECRUITING

Long Term Extension Study in Patients With Primary Hyperoxaluria

Study Summary

The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (\<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.

Conditions
Primary Hyperoxaluria Type 1 (PH1)Primary Hyperoxaluria Type 2 (PH2)Kidney DiseasesUrologic DiseasesGenetic DiseasePrimary Hyperoxaluria Type 3 (PH3)
Interventions / Drugs
DCR-PHXC
View on ClinicalTrials.gov ↗
Sponsor
NVO
Novo Nordisk
Diabetes/Obesity
F12/100
Study Details
Enrollment75 participants
Primary Completion—
Lead SponsorDicerna Pharmaceuticals, Inc., a Novo Nordisk company
Data Retrieved2026-04-11 02:55:47.366627+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 75 participants
Sponsor Catalyst Profile

Novo Nordisk (NVO) is the sponsoring company for this trial. BiotechSign currently grades this company F (12/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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