Cardiovascular DiseasesPhase 2VITAL-IMPACTNCT06320951
VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
A Phase 2 study testing Vericiguat 10 MG, Insulin Sensitivity Test and Resting Energy and Exercise Energy Expenditure Assessment in people with Cardiovascular Diseases and Insulin Sensitivity/Resistance, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Insulin Sensitivity/Resistance, Metabolic Disease
- What is being tested?
- Vericiguat 10 MG, Insulin Sensitivity Test and Resting Energy and Exercise Energy Expenditure Assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults: Age more than or equal to 18 years of age
- Self-identified race/ethnicity as African-American or Black
- BMI ≥ 30 kg/m2
- HOMA-IR ≥ 2.5
- Blood pressure: 120-160/80-100 mmHg (untreated or 1 week of washout in those treated with up to two classes of antihypertensives)
- Willing to adhere to study protocol
Who cannot join
- Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
- Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, seizure or cardiac arrhythmia)
- BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives
- BMI >45 kg/m2
- History of diabetes or fasting plasma glucose >=126 mg/dL or HbA1C>=6.5% or prior treatment with antidiabetics
- Estimated GFR < 60 ml/min/1.73 m2; albumin-creatinine ratio ≥30 mg/g
Show all 10Show fewer
- Hepatic Transaminase (AST and ALT) levels >3x the upper limit of normal
- Significant psychiatric illness (assessed using validated MINI questionnaire)
- Anemia (men, Hb<13 g/dL; women, Hb <12 g/dL)
- Inability to exercise on a treadmill
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals.
Read the detailed description
Obese Black individuals have a higher prevalence of insulin resistance, which is linked to an elevated risk of cardiometabolic diseases and cardiovascular disease. The reasons behind the increased insulin resistance in this group are not fully understood. Key to regulating glucose metabolism and the overall balance of energy, the cyclic guanosine monophosphate (cGMP) pathway is crucial for maintaining cardiometabolic health. Research indicates that both Black race and obesity are associated with reduced levels of upstream regulators of cGMP activity, including natriuretic peptides (NPs) and nitric oxide (NO). This reduced level of NPs and NO predisposes Black obese individuals to decreased cGMP activity, potentially contributing to the higher occurrence of cardiometabolic diseases seen in this population. Vericiguat, a drug that stimulates the soluble guanylate cyclase, thereby enhancing cGMP activity independently of NO, presents a novel approach to improving cardiometabolic health in those most at risk due to low cGMP activity. This study hypothesizes that directly augmenting cGMP levels with vericiguat will improve cardiometabolic health parameters including insulin sensitivity and energy expenditure in Black obese adults with insulin resistance. Investigators plan to execute a placebo-controlled randomized trial targeting Black obese participants with insulin resistance to examine whether vericiguat can (1) improve insulin sensitivity and (2) increase resting energy expenditure. For the first aim, Investigators aim to enroll 200 Black obese (BMI≥30 kg/m^2) individuals with a HOMA-IR of ≥2.5, randomizing them to either vericiguat 10 mg once daily or a placebo once daily in a double-blind setup for 12 weeks. Investigators will assess improvements in insulin sensitivity through euglycemic hyperinsulinemic clamp and compare the results between the vericiguat and placebo groups after 12 weeks. For the second aim, Investigators will evaluate changes in resting and exercise energy expenditure across both groups over the same period. An exploratory objective will investigate changes in brown adipose tissue volume and activity using PET-MRI, as well as UCP1 gene expression in white adipose tissue, in a subset of 100 participants after 12 weeks of vericiguat treatment. This will offer insights into the mechanisms by which cGMP augmentation may facilitate improvements in cardiometabolic health. By focusing on the direct enhancement of cGMP activity in Black obese individuals, this study proposes a novel targeted therapeutic strategy aimed at improving cardiometabolic health and addressing the increasing prevalence of cardiometabolic disease in the Black population.
- Conditions
- Cardiovascular Diseases, Insulin Sensitivity/Resistance, Metabolic Disease, Metabolism, Energy Expenditure, Obesity
- Being tested
- Vericiguat 10 MG, Placebo, Insulin Sensitivity Test, Resting Energy and Exercise Energy Expenditure Assessment, White Adipose Tissue Biopsy
- Keywords
- Energy Expenditure, Insulin Sensitivity, African Americans, Cyclic Guanosine Monophosphate
- Medical subject headings
- Cardiovascular Diseases, Insulin Resistance, Metabolic Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat 10 MGDrug
Also called Vericiguat Arm
The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.
PlaceboOther
Also called Placebo Arm
The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.
Insulin Sensitivity TestOther
An assessment of the insulin sensitivity will be done using the Euglycemic Hyperinsulinemic Clamp, at baseline and after 12 weeks of pharmacological interventions.
Resting Energy and Exercise Energy Expenditure AssessmentOther
Also called Resting and Exercise Induced Energy Expenditure Test
Each participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions.
White Adipose Tissue BiopsyOther
Participants who consent to participate in the exploratory aim will undergo WAT biopsy to assess UCP1 gene expression from the collected biospecimens, at baseline and after 12 weeks of pharmacological interventions.
MRI-PET Scan for Brown Adipose Tissue Volume AssessmentOther
Participants who consent to participate in the exploratory aim will undergo PET/MR to BAT volume at baseline and after 12 weeks of pharmacological interventions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Vericiguat | Experimental | The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks. Receives: Drug: Vericiguat 10 MG; Other: Insulin Sensitivity Test; Other: Resting Energy and Exercise Energy Expenditure Assessment; Other: White Adipose Tissue Biopsy; Other: MRI-PET Scan for Brown Adipose Tissue Volume Assessment |
| Placebo | Placebo comparator | The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks. Receives: Other: Placebo; Other: Insulin Sensitivity Test; Other: Resting Energy and Exercise Energy Expenditure Assessment; Other: White Adipose Tissue Biopsy; Other: MRI-PET Scan for Brown Adipose Tissue Volume Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance.
The difference in change in insulin sensitivity between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance.
The difference in change in REE between baseline and post-intervention between two arms.
Measured: 12 weeks
Secondary outcomes (8)
Change in BAT volume after vericiguat in Black obese individuals with insulin resistance.
The difference in change in BAT volume between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in BAT activity after vericiguat in Black obese individuals with insulin resistance.
The difference in change in BAT activity between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance.
The difference in change in UCP1 gene expression between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance.
The difference in change in EEE between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance.
The difference in change in HbA1C between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance.
The difference in change in BMI between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance.
The difference in change in TC between baseline and post-intervention between two arms.
Measured: 12 weeks
Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance.
The difference in change in LDL-C between baseline and post-intervention between two arms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Dec 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pankaj Arora, MD, University of Alabama at Birmingham
- Investigators
- Pankaj Arora, MD, FAHA, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320951
- Sponsor's protocol ID
- 300012681
- Other IDs
- Pending
- Acronym
- VITAL-IMPACT
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
- ClinicalTrials.gov ID
- NCT06320951
- Acronym / sponsor ID
- VITAL-IMPACT / 300012681
- Conditions
- Cardiovascular Diseases, Insulin Sensitivity/Resistance, Metabolic Disease, Metabolism, Energy Expenditure, Obesity
- Keywords
- Energy Expenditure, Insulin Sensitivity, African Americans, Cyclic Guanosine Monophosphate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the potential of vericiguat, a soluble guanylate cyclase stimulator, to improve cardiometabolic health in obese Black individuals with insulin resistance by directly enhancing cyclic guanosine monophosphate (cGMP) activity. Given that this population has been shown to have lower cGMP activity and the association of lower cGMP activity with increased cardiometabolic disease risk, the proposed study hypothesizes that augmenting cGMP activity in obese individuals will improve insulin sensitivity and energy expenditure. This study is a placebo-controlled randomized trial involving 200 Black obese participants with insulin resistance, assessing the effects of vericiguat on insulin sensitivity, resting, and exercise-induced energy expenditure over 12 weeks. Additionally, it will explore changes in brown adipose tissue and gene expression related to energy metabolism in white adipose tissue, aiming to provide insights into how increasing cGMP activity may improve cardiometabolic health in Black obese individuals.
Detailed description
Obese Black individuals have a higher prevalence of insulin resistance, which is linked to an elevated risk of cardiometabolic diseases and cardiovascular disease. The reasons behind the increased insulin resistance in this group are not fully understood. Key to regulating glucose metabolism and the overall balance of energy, the cyclic guanosine monophosphate (cGMP) pathway is crucial for maintaining cardiometabolic health. Research indicates that both Black race and obesity are associated with reduced levels of upstream regulators of cGMP activity, including natriuretic peptides (NPs) and nitric oxide (NO). This reduced level of NPs and NO predisposes Black obese individuals to decreased cGMP activity, potentially contributing to the higher occurrence of cardiometabolic diseases seen in this population. Vericiguat, a drug that stimulates the soluble guanylate cyclase, thereby enhancing cGMP activity independently of NO, presents a novel approach to improving cardiometabolic health in those most at risk due to low cGMP activity. This study hypothesizes that directly augmenting cGMP levels with vericiguat will improve cardiometabolic health parameters including insulin sensitivity and energy expenditure in Black obese adults with insulin resistance. Investigators plan to execute a placebo-controlled randomized trial targeting Black obese participants with insulin resistance to examine whether vericiguat can (1) improve insulin sensitivity and (2) increase resting energy expenditure. For the first aim, Investigators aim to enroll 200 Black obese (BMI≥30 kg/m^2) individuals with a HOMA-IR of ≥2.5, randomizing them to either vericiguat 10 mg once daily or a placebo once daily in a double-blind setup for 12 weeks. Investigators will assess improvements in insulin sensitivity through euglycemic hyperinsulinemic clamp and compare the results between the vericiguat and placebo groups after 12 weeks. For the second aim, Investigators will evaluate changes in resting and exercise energy expenditure across both groups over the same period. An exploratory objective will investigate changes in brown adipose tissue volume and activity using PET-MRI, as well as UCP1 gene expression in white adipose tissue, in a subset of 100 participants after 12 weeks of vericiguat treatment. This will offer insights into the mechanisms by which cGMP augmentation may facilitate improvements in cardiometabolic health. By focusing on the direct enhancement of cGMP activity in Black obese individuals, this study proposes a novel targeted therapeutic strategy aimed at improving cardiometabolic health and addressing the increasing prevalence of cardiometabolic disease in the Black population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Vericiguat | Experimental | Drug: Vericiguat 10 MG, Other: Insulin Sensitivity Test, Other: Resting Energy and Exercise Energy Expenditure Assessment, Other: White Adipose Tissue Biopsy, Other: MRI-PET Scan for Brown Adipose Tissue Volume AssessmentThe subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks. |
| Placebo | Placebo comparator | Other: Placebo, Other: Insulin Sensitivity Test, Other: Resting Energy and Exercise Energy Expenditure Assessment, Other: White Adipose Tissue Biopsy, Other: MRI-PET Scan for Brown Adipose Tissue Volume AssessmentThe subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults: Age more than or equal to 18 years of age
- Self-identified race/ethnicity as African-American or Black
- BMI ≥ 30 kg/m2
- HOMA-IR ≥ 2.5
- Blood pressure: 120-160/80-100 mmHg (untreated or 1 week of washout in those treated with up to two classes of antihypertensives)
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
- Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, seizure or cardiac arrhythmia)
- BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives
- BMI >45 kg/m2
- History of diabetes or fasting plasma glucose >=126 mg/dL or HbA1C>=6.5% or prior treatment with antidiabetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vericiguat 10 MGAlso: Vericiguat ArmThe subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks. | Drug | Experimental: Vericiguat |
| PlaceboAlso: Placebo ArmThe subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks. | Other | Placebo |
| Insulin Sensitivity TestAn assessment of the insulin sensitivity will be done using the Euglycemic Hyperinsulinemic Clamp, at baseline and after 12 weeks of pharmacological interventions. | Other | Experimental: Vericiguat, Placebo |
| Resting Energy and Exercise Energy Expenditure AssessmentAlso: Resting and Exercise Induced Energy Expenditure TestEach participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions. | Other | Experimental: Vericiguat, Placebo |
| White Adipose Tissue BiopsyParticipants who consent to participate in the exploratory aim will undergo WAT biopsy to assess UCP1 gene expression from the collected biospecimens, at baseline and after 12 weeks of pharmacological interventions. | Other | Experimental: Vericiguat, Placebo |
| MRI-PET Scan for Brown Adipose Tissue Volume AssessmentParticipants who consent to participate in the exploratory aim will undergo PET/MR to BAT volume at baseline and after 12 weeks of pharmacological interventions. | Other | Experimental: Vericiguat, Placebo |
Primary outcome
Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
The difference in change in insulin sensitivity between baseline and post-intervention between two arms.
Change in resting energy expenditure (REE) after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
The difference in change in REE between baseline and post-intervention between two arms.
8 secondary outcomes
Change in BAT volume after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in BAT activity after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pankaj Arora, MD, FAHA principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vericiguat 10 MG, Insulin Sensitivity Test and Resting Energy and Exercise Energy Expenditure Assessment in people with Cardiovascular Diseases and Insulin Sensitivity/Resistance, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nehal Vekariya, MS (2059347173, nvekariya@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.