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Stimulator of Soluble Guanylyl Cyclase

Vericiguat for Metabolic Syndrome

Phase 2
Recruiting
Led By Thorsten M Leucker, M.D., Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of the metabolic syndrome defined by the National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) definition, with at least three of the following five criteria: waist circumference > 40 inches (men) or >35 inches (women), blood pressure >130/80 mmHg, fasting triglyceride (TG) level >150 mg/dL, fasting high-density lipoprotein (HDL) cholesterol level <40mg/dL in men or <50mg/dL in women, Fasting blood glucose >100 mg/dL
Age range 35-85 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks following initiation of up-titrated dose
Awards & highlights

Study Summary

This trial will test a drug to see if it can improve coronary vascular function in people with metabolic syndrome and coronary vascular dysfunction.

Who is the study for?
Adults aged 35-85 with metabolic syndrome as defined by NCEP ATP III, which includes having a large waistline, high blood pressure, elevated fasting triglycerides, low HDL cholesterol levels, and raised fasting blood glucose. Participants should not be pregnant or have metal exposure risks due to past occupations like welding. They must also be able to undergo MRI scans without issues such as claustrophobia.Check my eligibility
What is being tested?
The trial is testing Vericiguat against a placebo in individuals with metabolic syndrome and coronary vascular dysfunction. The study is randomized and double-blind meaning neither the participants nor the researchers know who gets the real treatment versus placebo. The effect on coronary vascular function will be measured using cardiac MRI imaging.See study design
What are the potential side effects?
While specific side effects of Vericiguat are not listed here, common ones may include headaches, dizziness due to low blood pressure (especially since those with systolic BP <110 mm Hg are excluded), digestive disturbances or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I meet at least three criteria for metabolic syndrome according to NCEP ATP III.
Select...
I am between 35 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks following initiation of up-titrated dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks following initiation of up-titrated dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute change in coronary cross-sectional area (in mm²) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
Absolute change in coronary cross-sectional area (in mm²) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)
Absolute change in coronary flow (in mL/min) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)
+5 more
Secondary outcome measures
Changes in E/e' ratio as assessed by echocardiography
Changes in cyclic guanosine monophosphate (cGMP) measured using blood samples (in pmol/mL)
Changes in e' velocities (in cm/s) as assessed by echocardiography
+9 more

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534
15%
Hypotension
7%
Dizziness
7%
Anaemia
6%
Cardiac failure
5%
Dyspnoea
5%
Nasopharyngitis
5%
Diarrhoea
4%
Pneumonia
4%
Hyperkalaemia
3%
Acute kidney injury
2%
Syncope
2%
Chronic kidney disease
2%
Chronic obstructive pulmonary disease
1%
Gastroenteritis
1%
Ventricular tachycardia
1%
Cardiac failure congestive
1%
Sepsis
1%
Renal failure
1%
Cellulitis
1%
Atrial fibrillation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vericiguat
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VericiguatExperimental Treatment1 Intervention
Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily.
Group II: PlaceboPlacebo Group1 Intervention
A placebo tablet will be administered orally once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vericiguat
2016
Completed Phase 3
~5050

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,735 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,012 Total Patients Enrolled
Thorsten M Leucker, M.D., Ph.D.Principal InvestigatorJohns Hopkins University

Media Library

Vericiguat (Stimulator of Soluble Guanylyl Cyclase) Clinical Trial Eligibility Overview. Trial Name: NCT05711719 — Phase 2
Nephrotic Syndrome Research Study Groups: Placebo, Vericiguat
Nephrotic Syndrome Clinical Trial 2023: Vericiguat Highlights & Side Effects. Trial Name: NCT05711719 — Phase 2
Vericiguat (Stimulator of Soluble Guanylyl Cyclase) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05711719 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include senior citizens as participants?

"Participants in this medical trial must be 35 to 85 years old. Excluding these individuals, 379 trials are recruiting patients below the age of 18 and 1024 studies require people above 65."

Answered by AI

To what degree can the use of Vericiguat be detrimental to one's health?

"The safety of Vericiguat has been evaluated and received a rating of 2. This is because this Phase 2 clinical trial has supplied evidence of the drug's security, even though no data exists to confirm its efficacy."

Answered by AI

Are there still opportunities to sign up for this experiment?

"As indicated by clinicaltrials.gov, this medical trial is not currently accepting participants. Initially posted in March of 2023 and recently updated in January, 1456 other studies are actively seeking patients as an alternative."

Answered by AI

What objectives does this research endeavor seek to fulfill?

"The primary outcome metric of this investigation, ascertained over a period that commences with the Baseline and concludes 6 weeks after commencement of the up-titrated dosage timeframe, is Relative fluctuation in coronary flow (as percentage) as determined by Magnetic Resonance Imaging (MRI). Secondary outcomes include metrics such as Alterations in interleukin 6 (IL-6), interleukin 10 (IL-10), and tumor necrosis factor alpha(TNF)-alpha which are all measured using blood samples."

Answered by AI

Who meets the criteria to participate in this experiment?

"This medical experiment is searching for 45 participants aged between 35 and 85 with metabolic syndrome. Subjects must also have a waist circumference above 40 inches (for men) or over 35 inches (for women), blood pressure in excess of 130/80 mmHg, fasting triglyceride level higher than 150 mg/dL, an HDL cholesterol count less than 40mg/dL if male, 50mg/dL if female and more importantly, glucose levels greater than 100 mg/DL. Furthermore, individuals may not be suffering from any arterial conditions unless they are older than 40 years old as males or over 50 years old as females; yet even then these"

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
2023. "Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05711719.
All > Nephrotic Syndrome
~24 spots leftby Jun 2025
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