Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	Safety: Treatment-emergent adverse events and serious adverse events	Baseline through 14 weeks	Treatment-emergent adverse events and serious adverse events
Primary	Safety: Incidence of anti-drug antibodies	Baseline, 4 weeks, and 14 weeks	Incidence of anti-drug antibodies
Secondary	Inflammatory biomarker C-reactive protein	Baseline, 12 weeks	Change in concentration from baseline at 12 weeks
Secondary	CCR2+ Myocardial Imaging (optional)	Baseline compared to 12 weeks	Mean change in CCR2+ cell myocardial infiltration measured by CCR2+ PET/CT imaging (standardized uptake value)
Secondary	Ventricular tachycardia	Baseline compared to 12 weeks	Number of ventricular tachycardia runs in a 7-day Holter monitor
Secondary	Ventricular premature contractions	Baseline compared to 12 weeks	Frequency of ventricular premature contractions in a 7-day Holter monitor
Secondary	Sustained and non-sustained ventricular tachycardia	Baseline through 12 weeks	Number of episodes of sustained and non-sustained ventricular tachycardia documented by ICD
Secondary	Treated ventricular tachycardia	Baseline through 12 weeks	Number of episodes of treated ventricular tachycardia (pacemaker and/or defibrillation) by ICD
Secondary	Atrial premature contractions	Baseline compared to 12 weeks	Number of atrial premature contractions in a 7-day Holter monitor
Secondary	New York Heart Association (NYHA) Functional Class	Baseline compared to 12 weeks	Change in NYHA Functional Class Questionnaire
Secondary	Implantable cardioverter/defibrillator (ICD) discharges	Baseline through 12 weeks	Frequency of ICD discharges (appropriate and/or inappropriate)
Secondary	Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire	Baseline compared to 12 weeks	Change in Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire, range 0 (very poor) to 65 (excellent)
Secondary	Disease biomarker Troponin I	Baseline, 12 weeks	Change in concentration from baseline at 12 weeks
Secondary	Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP)	Baseline, 12 weeks	Change in concentration from baseline at 12 weeks
Secondary	Inflammatory biomarker interleukin (IL)1-beta	Baseline, 12 weeks	Change in concentration from baseline at 12 weeks
Secondary	Pharmacokinetics: Serum IC14 concentration versus time curve	Baseline through 14 weeks	Area under the serum concentration versus time curve (AUC)
Secondary	Pharmacokinetics: Peak serum IC14 concentration	Baseline through 14 weeks	Peak serum IC14 concentration
Secondary	Pharmacokinetics: Half life	Baseline through 14 weeks	Half-life of serum IC14 concentration
Secondary	Pharmacodynamics: Receptor Occupancy	Baseline through 14 weeks	Measurement of monocyte membrane CD14 receptor occupancy
Secondary	Pharmacodynamics: Effective Concentration 95%	Baseline through 14 weeks	Estimation of serum concentration of IC14 to achieve 95% monocyte membrane receptor occupancy

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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