Phase 3 Peripheral Neuropathy Trial, Recruiting NCT07223203 Sponsor: Alnylam Pharmaceuticals Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT07223203
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been formally diagnosed with hereditary ATTR amyloidosis with polyneuropathy (a genetic condition that damages nerves), sometimes called hATTR-PN.
  • People whose diagnosis has been confirmed by a genetic test showing a change (variant) in the TTR gene.
  • People whose nerve damage has been measured using a standard scoring tool (called the Neuropathy Impairment Score) and falls between 5 and 130.
  • People whose general physical functioning has been rated at 60% or above on a standard medical scale (called the Karnofsky Performance Status), meaning they are able to care for themselves and carry out normal activity at least some of the time (confirm with trial site).

Who may not be able to join:

  • People who have previously had a liver transplant, or who the trial doctor believes are likely to need one during the study.
  • People who have a different type of amyloidosis (not the hereditary TTR type), or who show signs of amyloid affecting the membranes around the brain and spinal cord.
  • People whose heart failure has been rated above level 2 on the standard New York Heart Association scale, meaning more significant heart-related limitations (confirm with trial site).
  • People whose liver enzyme levels (specifically ALT or AST) are more than 2.5 times the upper limit of the normal range on a blood test.
  • People whose bilirubin level (a marker of liver function) is more than 1.5 times the upper limit of the normal range on a blood test.
  • People whose kidneys are not filtering blood well enough, as measured by a standard kidney function test falling at or below a certain threshold (confirm with trial site for exact values).
  • People whose nerve damage is known to be caused by something other than hATTR amyloidosis.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Alnylam Pharmaceuticals

Phone: 1-877-ALNYLAM

Australian sites

Clinical Trial Site, Darlinghurst,
Clinical Trial Site, Woolloongabba,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Alnylam Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
12 December 2025
Est. completion
27 December 2027

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil Cyprus 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from Baseline in the Modified Neuropathy Impairment Score +7 (mNIS+7) Compared to the External Placebo Group from the APOLLO Study (NCT01960348) at Month 9

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov