Trial Outcomes & Findings for Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction (NCT NCT05711719)
NCT ID: NCT05711719
Last Updated: 2026-01-27
Results Overview
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
COMPLETED
PHASE2
45 participants
Baseline and 6 weeks following initiation of up-titrated dose
2026-01-27
Participant Flow
A total of 45 participants were enrolled (provided written informed consent) and underwent screening MRI. 11 participants were excluded from the study before assignment to veiciguat or placebo: six had normal coronary endothelial function, image quality was poor in two, one experienced claustrophobia, one withdrew and one was lost to follow-up. 34 participants were subsequently randomized.
Participant milestones
| Measure |
Vericiguat
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Placebo
A placebo tablet will be administered orally once daily.
Placebo: Administered the same way
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
11
|
|
Overall Study
COMPLETED
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
Baseline characteristics by cohort
| Measure |
Vericiguat
n=23 Participants
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Placebo
n=11 Participants
A placebo tablet will be administered orally once daily.
Placebo: Administered the same way
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 8.9 • n=41 Participants
|
59.6 years
STANDARD_DEVIATION 7.5 • n=1581 Participants
|
60.6 years
STANDARD_DEVIATION 8.6 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
14 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
34 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
27 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated dosePopulation: Two participants who were assigned to the Vericiguat group withdrew. One withdrew due to personal bereavement following the unexpected death of a close friend, and the other withdrew due to lightheadedness and nausea following alcohol intake.
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
Outcome measures
| Measure |
Vericiguat (Baseline)
n=21 Participants
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Vericiguat Group (Follow-up Visit)
n=21 Participants
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.
|
|---|---|---|
|
Absolute Change in Coronary Cross-sectional Area (in mm²) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
|
-1.11 mm^2
Standard Deviation 1.17
|
0.40 mm^2
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated dosePopulation: Two participants who were assigned to the vericiguat group withdrew. One withdrew due to personal bereavement following the unexpected death of a close friend, and the other withdrew due to lightheadedness and nausea following alcohol intake.
The difference in relative change in coronary cross-sectional area (in %) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
Outcome measures
| Measure |
Vericiguat (Baseline)
n=21 Participants
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Vericiguat Group (Follow-up Visit)
n=21 Participants
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.
|
|---|---|---|
|
Relative Change in Coronary Cross-sectional Area (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
|
-6.8 percent change
Standard Deviation 6.7
|
3.1 percent change
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated dosePopulation: In the vericiguat arm, two participants withdrew. One withdrew due to personal bereavement following the unexpected death of a close friend, and the other withdrew due to lightheadedness and nausea following alcohol intake.
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) as assessed by MRI.
Outcome measures
| Measure |
Vericiguat (Baseline)
n=21 Participants
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Vericiguat Group (Follow-up Visit)
n=11 Participants
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.
|
|---|---|---|
|
Absolute Change in Coronary Cross-sectional Area (in mm²) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
|
0.40 mm^2
Standard Deviation 1.28
|
-0.003 mm^2
Standard Deviation 1.18
|
PRIMARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated dosePopulation: In the vericiguat arm, two participants withdrew. One withdrew due to personal bereavement following the unexpected death of a close friend, and the other withdrew due to lightheadedness and nausea following alcohol intake.
The difference in percentage change in coronary cross-sectional area (%) from rest to isometric handgrip exercise (IHE) between the vericiguat and placebo groups, as assessed from the baseline MRI to the follow-up MRI, six weeks following initiation of the titrated dose.
Outcome measures
| Measure |
Vericiguat (Baseline)
n=21 Participants
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Vericiguat Group (Follow-up Visit)
n=11 Participants
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.
|
|---|---|---|
|
Difference in Percent Change in Coronary Cross-sectional Area (as Percentage) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
|
9.9 % change coronary cross-sectional area
Standard Deviation 9.80
|
8.8 % change coronary cross-sectional area
Standard Deviation 13.20
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseIL-1 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseIL-6 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseIL-10 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseTNF-alpha (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated dosehsCRP (in mg/L), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated dosecGMP (in pmol/mL), a mediator in the nitric oxide pathway, will be measured in blood samples to assess changes from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseAn ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on left ventricular ejection fraction (%).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseAn ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on e' velocities (in cm/s).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseAn ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the E/e' ratio.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseAn ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the left atrium volume index (in mL/BSA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseAn ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on peak TR velocity (in m/s).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseAn ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on strain (as percentage).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseThe absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseThe relative changes in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseThe absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 weeks following initiation of up-titrated doseThe relative changes in in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Outcome measures
Outcome data not reported
Adverse Events
Vericiguat
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vericiguat
n=23 participants at risk
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.
Vericiguat: Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
|
Placebo
n=11 participants at risk
A placebo tablet will be administered orally once daily.
Placebo: Administered the same way
|
|---|---|---|
|
Vascular disorders
Orthostatic dizziness
|
8.7%
2/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Gastrointestinal disorders
Dysphagia
|
8.7%
2/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Gastrointestinal disorders
Heartburn
|
13.0%
3/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
General disorders
Dizziness
|
4.3%
1/23 • up to 156 days
|
27.3%
3/11 • up to 156 days
|
|
General disorders
Unsteadiness
|
0.00%
0/23 • up to 156 days
|
18.2%
2/11 • up to 156 days
|
|
Nervous system disorders
Forgetfulness
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Gastrointestinal disorders
Vomiting after alcohol consumption
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
General disorders
Fatigue
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Vascular disorders
Syncope
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Cardiac disorders
Palpitations after influenza vaccination
|
0.00%
0/23 • up to 156 days
|
9.1%
1/11 • up to 156 days
|
|
Social circumstances
Anxiety following mother's cancer diagnosis
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Cardiac disorders
Chest discomfort with exercise
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
General disorders
Epitaxis
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
General disorders
Increased thirst
|
0.00%
0/23 • up to 156 days
|
9.1%
1/11 • up to 156 days
|
|
Skin and subcutaneous tissue disorders
Rash following yard work
|
0.00%
0/23 • up to 156 days
|
9.1%
1/11 • up to 156 days
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
|
General disorders
Low fasting glucose
|
4.3%
1/23 • up to 156 days
|
9.1%
1/11 • up to 156 days
|
|
General disorders
Low potassium
|
4.3%
1/23 • up to 156 days
|
0.00%
0/11 • up to 156 days
|
Additional Information
Thorsten M. Leucker, MD, PhD
Johns Hopkins University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place