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CLR325

Phase 2

Chronic Stable Heart Failure | Small molecule | Cardiovascular |Novartis AG|Last Updated: Jan 5, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02696967A Study of CLR325 in Chronic Stable Heart Failure Patients.PHASE2 COMPLETED 26 — — May 17, 2016Jan 14, 2019Jan 5, 202111 United States, Belgium +3
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Study Endpoints
Primary Endpoints
Number of Patients With Adverse Events, Serious Adverse Events and Death
Day 1 to 28

Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that CLR325 is safe for the treatment of chronic stable heart-failure patients through the monitoring of relevant clinical and laboratory safety parameters.

Secondary Endpoints
Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to 18 Hours (AUC0-18hr)
0, 0.5, 3, 5, 8, 10, 12, and 18 hours post start of CLR325 infusion on Day 1
Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs)
0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1
Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)
0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CLR325EXPERIMENTALPatients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of CLR325 (i.v.) in double blind manner.
PlaceboPLACEBO_COMPARATORPatients were assigned to one of the 2 treatment arms in fixed randomization ratio. Patients randomized to this arm received single dose of placebo (i.v.) in double blind manner.
Interventions
NameTypeDescription
CLR325DRUGCLR325 Concentrate for solution for infusion
PlaceboOTHERNormal saline
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Key Inclusion Criteria: * Male and female patients \>18 years of age * Body weight between 50 kg and 140 kg * Cardiac ejection fraction of ≤ 45% assessed within the last 6 months * For PA catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place pr...

Countries:United StatesBelgiumGermanyNetherlandsSingapore
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