Vericiguat tablet / Heart Failure / Vericiguat suspension · Phase 2/3 Trial

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 2/3 trial of vericiguat versus placebo in pediatric heart failure with left ventricular systolic dysfunction. No results have been posted in this registry record. The trial is actively recruiting and designed to evaluate efficacy via NT-proBNP change at Week 16 and longer-term safety over approximately 8 years.

What was studied

Phase 2/3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Heart Failure, Left Ventricular Systolic Dysfunction; age from 29 Days; to 17 Years. Intervention: Base Period: Vericiguat; Extension Period: Vericiguat. Compared with: Base Period: Placebo — Placebo Comparator. n = 342. 108 sites across 30 countries.

Key findings

Safety

This is a registry record; no efficacy or safety results are reported. Primary endpoint is a biomarker (NT-proBNP); clinical outcomes such as morbidity, mortality, or hospitalization are not described as primary outcomes in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing a planned Phase 2/3 study with no results posted; enrollment is ongoing and primary outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) (assessed at Baseline and Week 16 of Base Period); Extension Period: Percentage of participants with one or more adverse events (AEs) (assessed at Includes data collected up to a maximum of approximately 8 years); Extension Period: Percentage of participants who discontinued study drug due to an AE (assessed at Includes data collected up to a maximum of approximately 8 years)

DesignPhase 2/3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationHeart Failure, Left Ventricular Systolic Dysfunction; age from 29 Days; to 17 Years

Sample size342

InterventionBase Period: Vericiguat; Extension Period: Vericiguat

ComparatorBase Period: Placebo — Placebo Comparator

Setting108 sites across 30 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment342

Study phasePhase 2/Phase 3

Primary efficacy endpoint (Base Period)Change from baseline to Week 16 in NT-proBNP

Primary safety endpoint (Extension Period)Percentage of participants with one or more adverse events, up to approximately 8 years

Primary safety endpoint (Extension Period)Percentage of participants who discontinued study drug due to an adverse event, up to approximately 8 years

Caveats

This is a registry record; no efficacy or safety results are reported.
Study is still recruiting and has not completed enrollment or follow-up.
Blinding methods, randomization procedure, and inclusion/exclusion criteria are not detailed in this registry entry.
Primary endpoint is a biomarker (NT-proBNP); clinical outcomes such as morbidity, mortality, or hospitalization are not described as primary outcomes in this record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Planned Phase 2/3 interventional trial with placebo control and extended safety follow-up.

Directness

moderate

Primary endpoint is NT-proBNP change, a biomarker; hard clinical outcomes not yet specified.

Consistency

insufficient

Registry record only; no results reported for comparison with other evidence.

Risk of bias

moderate

Placebo-controlled design planned; blinding status and allocation concealment not detailed.

Sample adequacy

moderate

Estimated 342 participants planned; adequate for Phase 2/3, but enrollment ongoing.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05714085). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 342 participants (ESTIMATED). Conditions: Heart Failure, Left Ventricular Systolic Dysfunction. Interventions: DRUG: Vericiguat tablet; DRUG: Vericiguat suspension; DRUG: Placebo tablet; DRUG: Placebo suspension. Primary outcome measures: Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP) , Baseline and Week 16 of Base Period; Extension Period: Percentage of participants with one or more adverse events (AEs) , Includes data collected up to a maximum of approximately 8 years; Extension Period: Percentage of participants who discontinued study drug due to an AE , Includes data collected up to a maximum of approximately 8 years. Brief summary: This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Vericiguat tabletHeart FailureMerck Sharp & DohmeVericiguat suspensionPlacebo tabletNCT05714085Placebo suspensionLeft Ventricular Systolic Dysfunction