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Looking for participantsPhase3

Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease

Sponsor: Alnylam Pharmaceuticals

NCT ID: NCT07181109

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zilebesiran (drug), Placebo (drug)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Zilebesiran — drug: Zilebesiran will be administered SC · Placebo — drug: Placebo will be administered SC
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
11,000
Started
2025-09-22
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for high risk cardiovascular disease
  • • Phase3 - 11,000 participants
  • • The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with high risk cardiovascular disease

Where?

  • • Ashburton - Clinical Trial Site
  • • Belfast - Clinical Trial Site
  • • Bellshill - Clinical Trial Site
  • • Birmingham - Clinical Trial Site
  • • +45 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.

High Risk Cardiovascular DiseaseHypertensionHigh Cardiovascular Risk

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Is 18 years or older for patients with established cardiovascular disease (CVD)
  • ✓Is 55 years or older for patients with high risk for CVD
  • ✓Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
  • ✓Has treated hypertension on stable therapy with at least 2 the usual treatment antihypertensive medications, one of...

Who cannot take part

  • ✗Has known history of secondary hypertension
  • ✗Has causing symptoms orthostatic hypotension
  • ✗Has alanine aminotransferase (liver enzymes) or aspartate aminotransferase (liver enzymes) \>3×upper limit of normal (ULN)
  • ✗Has total serum liver blood test \>1.5×ULN
  • ✗Has international normalized ratio (INR) \>1.5
See the full criteria
Inclusion Criteria: * Is 18 years or older for patients with established cardiovascular disease (CVD) * Is 55 years or older for patients with high risk for CVD * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD * Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic Exclusion Criteria: * Has known history of secondary hypertension * Has symptomatic orthostatic hypotension * Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN) * Has total serum bilirubin \>1.5×ULN * Has international normalized ratio (INR) \>1.5 * Has serum potassium \>4.8 mEq/L * Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2

Where Is This Study? (49 UK sites)

Clinical Trial Site

Ashburton TQ13 7AP, United Kingdom

Recruiting

Clinical Trial Site

Belfast BT2 8BG, United Kingdom

Recruiting

Clinical Trial Site

Bellshill ML4 3NJ, United Kingdom

Recruiting

Clinical Trial Site

Birmingham B15 2SQ, United Kingdom

Recruiting

Clinical Trial Site

Birmingham B21 9RY, United Kingdom

Recruiting

Clinical Trial Site

Bristol BS2 8HW, United Kingdom

Recruiting

Clinical Trial Site

Bristol BS37 4AX, United Kingdom

Recruiting

Clinical Trial Site

Bury St Edmunds IP33 2QZ, United Kingdom

Recruiting

Clinical Trial Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Clinical Trial Site

Cardiff CF15 9SS, United Kingdom

Recruiting

Clinical Trial Site

Cardiff CF5 4AD, United Kingdom

Recruiting

Clinical Trial Site

Chichester PO19 6SE, United Kingdom

Recruiting

Clinical Trial Site

Corby NN17 2UR, United Kingdom

Recruiting

Clinical Trial Site

Darlington DL3 6HX, United Kingdom

Recruiting

Clinical Trial Site

Dorchester DT1 2JY, United Kingdom

NOT_YET_RECRUITING

Clinical Trial Site

Ely CB7 5JD, United Kingdom

Recruiting

Clinical Trial Site

Fowey PL23 1DT, United Kingdom

Recruiting

Clinical Trial Site

Glasgow G20 7BE, United Kingdom

Recruiting

Clinical Trial Site

Heston TW5 9ER, United Kingdom

Recruiting

Clinical Trial Site

Honiton EX14 2NY, United Kingdom

Recruiting

Clinical Trial Site

Ilford IG1 4HP, United Kingdom

Recruiting

Clinical Trial Site

Isleworth TW7 6AF, United Kingdom

Recruiting

Clinical Trial Site

Leeds LS26 9AA, United Kingdom

Recruiting

Clinical Trial Site

Liskeard PL14 3XA, United Kingdom

Recruiting

Clinical Trial Site

Liverpool L24 7RB, United Kingdom

Recruiting

Clinical Trial Site

Liverpool L9 7AL, United Kingdom

Recruiting

Clinical Trial Site

London EC1A 7BE, United Kingdom

Recruiting

Clinical Trial Site

London SE6 4LF, United Kingdom

Recruiting

Clinical Trial Site

Luton LU4 0DZ, United Kingdom

Recruiting

Clinical Trial Site

Manchester M13 9WL, United Kingdom

NOT_YET_RECRUITING

Clinical Trial Site

Manchester M27 8FF, United Kingdom

Recruiting

Clinical Trial Site

Metropolitan Borough of Wirral CH62 6EE, United Kingdom

Recruiting

Clinical Trial Site

Middlesbrough TS5 6HA, United Kingdom

Recruiting

Clinical Trial Site

Milton Keynes MK15 0DU, United Kingdom

Recruiting

Clinical Trial Site

Newquay TR7 1RU, United Kingdom

Recruiting

Clinical Trial Site

Northallerton DL7 8AW, United Kingdom

Recruiting

Clinical Trial Site

Penzance TR18 3DX, United Kingdom

Recruiting

Clinical Trial Site

Plymouth PL5 3JB, United Kingdom

Recruiting

Clinical Trial Site

Plympton PL7 1AD, United Kingdom

Recruiting

Clinical Trial Site

Poole BH16 5PW, United Kingdom

Recruiting

Clinical Trial Site

Redhill RH1 5RH, United Kingdom

Recruiting

Clinical Trial Site

Sale M33 4BR, United Kingdom

Recruiting

Clinical Trial Site

Swansea SA2 8QA, United Kingdom

Recruiting

Clinical Trial Site

Swindon SN3 6BB, United Kingdom

Recruiting

Clinical Trial Site

Teeside TS19 8PE, United Kingdom

Recruiting

Clinical Trial Site

Thetford IP24 1JD, United Kingdom

Recruiting

Clinical Trial Site

Torpoint PL11 2TB, United Kingdom

Recruiting

Clinical Trial Site

Wolverhampton WV9 5HB, United Kingdom

Recruiting

Clinical Trial Site

York YO24 2RQ, United Kingdom

Recruiting

How to Get in Touch

Clinical Trial Information Line

Sponsor contact

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Clinical Trial Information Line

Sponsor contact

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09