CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis

Study acronym: CLEOPATTRA
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 297 to 299
  2. Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Study sites: 295 to 297
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 10 of 21 entries
  3. Trial sites expanded: 292 → 295 locationsv13
  4. Study sites: 290 to 292v12
  5. Re-verified, no change to tracked fieldsv11
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  1. Eligibility criteria expanded, about 8 words
    • Study sites revised (290)
    v10
  2. Study sites: 289 to 290v9
  1. Primary endpoint(s) modified
    • Trial sites expanded: 285 → 289 locations
    • Eligibility criteria expanded, about 107 words
    v8
  2. Study sites: 278 to 285v7
  3. Study sites: 276 to 278v6
  4. Site details revised at 21 of 276 sitesv5
  5. Study sites revised (276)v4
  6. Study sites: 271 to 276v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 26, 2025 to Oct 2, 2025
    • Site details revised at 271 of 271 sites
    v2
  8. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novo Nordisk
269 trials monitored
See 14 trials at risk
Amyloidosis
330 trials monitored
See 20 trials at risk
This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.
Trial Details
NCT Number NCT07207811
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)		 Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Enrollment 1,280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov