A Phase 2/3 interventional study of Vericiguat tablet and Vericiguat suspension in Heart Failure and Left Ventricular Systolic Dysfunction, sponsored by Merck Sharp & Dohme LLC. Recruiting at 112 sites in 30 countries. Open to participants aged 29 Days to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2/3, Interventional, and Treatment
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.
As of Protocol Amendment 2, the separate open-label extension arm of study MK-1242-043 (NCT06428383) will be incorporated into the present MK-1242-036 study as an extension period. Participants from the Base Period will be provided the opportunity to participate in the optional open-label Extension Period if eligible. After all ongoing participants are transferred into the extension period of MK-1242-036, MK-1242-043 (NCT06428383) will be formally closed.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 342 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the Base Period receive 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form for 52 weeks; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form for 52 weeks.
Drug: Vericiguat tablet · Drug: Vericiguat suspension
Participants in the Base Period receive placebo for vericiguat administered orally once daily in tablet form for 52 weeks, or administered orally once daily in suspension form for 52 weeks.
Drug: Placebo tablet · Drug: Placebo suspension
Participants in the Extension Period receive either 2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form; or 0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form; following completion of the Base Period.
Drug: Vericiguat tablet · Drug: Vericiguat suspension
2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Also known as: MK-1242
0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Also known as: MK-1242
Placebo for vericiguat administered orally once daily in tablet form
Also known as: Placebo for MK-1242
Placebo for vericiguat administered orally once daily in suspension form
Also known as: Placebo for MK-1242
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
Time frame: Baseline and Week 16 of Base Period
Extension Period: Percentage of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported.
Time frame: Includes data collected up to a maximum of approximately 8 years
Extension Period: Percentage of participants who discontinued study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
Time frame: Includes data collected up to a maximum of approximately 8 years
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP
The change from baseline to Week 52 of the Base Period in log-transformed NT-proBNP will be reported.
Time frame: Baseline and Week 52 of Base Period
Base Period: First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
The time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization will be reported for the Base Period.
Time frame: Up to Week 54 of Base Period
Base Period: Percentage of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Base Period will be reported.
Time frame: Up to Week 54 of Base Period
Base Period: Percentage of participants who discontinued study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Base Period due to an AE will be reported.
Time frame: Up to Week 52 of Base Period
Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat.
Time frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Half-life (t1/2) of vericiguat in plasma
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the t1/2 of vericiguat in plasma.
Time frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Base Period: Oral clearance (CL/F) of plasma vericiguat
Blood samples were collected at pre-specified time points pre- and post-dose and used to estimate the CL/F of vericiguat in plasma.
Time frame: Pre-dose, 2, 6, 16, 32 and 52 weeks post-dose (Base Period)
Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP
The change from the Extension Period baseline to Week 16 of the Extension Period in log-transformed NT-proBNP will be reported.
Time frame: Extension Period Baseline (Study Week 54) and Extension Period Week 16 (Study Week 70)
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Showing the first 100 of 112 sites across 30 countries. Choose a country and city above to see the rest.
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started May 2023 (actual). Primary completion is estimated for Aug 2029, 74 months after the start.
Of 24 phase 2/3 interventional studies under Heart Failure, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 74 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Apr 2032 → Aug 2029 and completion Apr 2032 → May 2032.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Vericiguat