Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Intellia Therapeutics
Registry number NCT06128629
Started 13 December 2023 Today 16 October 2026 Estimated completion 1 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
The Canberra Hospital Garran ACT Recruiting
Westmead Hospital Westmead NSW Recruiting
Cairns Hospital Cairns QLD Withdrawn
Eastern Health - Box Hill Hospital Box Hill VIC Recruiting
Fiona Stanley Hospital Perth WA Recruiting
Royal Adelaide Hospital Adelaide Australia Recruiting
The Alfred Hospital Melbourne Australia Recruiting
Princess Alexandra Hospital Woolloongabba Australia Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 90 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 1200

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Documented diagnosis of ATTR amyloidosis with cardiomyopathy

* Medical history of heart failure (HF)

* Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention

* Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL

Exclusion Criteria:

* New York Heart Association (NYHA) Class IV HF

* Polyneuropathy Disability score of IV (confined to wheelchair or bed)

* Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

* History of active malignancy within 3 years prior to screening

* RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed

* Initiation of tafamidis or acoramidis within 56 days prior to study dosing

* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2

* History of liver disease

* Uncontrolled blood pressure

* Unable or unwilling to take vitamin A supplementation for the duration of the study

Dates on the record

Started 13 December 2023
Estimated completion 1 December 2027
Registry last updated 27 March 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 27 March 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.