VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway (VITAL-IMPACT)

January 21, 2026 updated by: Pankaj Arora, MD, University of Alabama at Birmingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Vericiguat
The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.
Drug: Vericiguat 10 MG
The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.
Other Names:
  • Vericiguat Arm
Other: Insulin Sensitivity Test
An assessment of the insulin sensitivity will be done using the Euglycemic Hyperinsulinemic Clamp, at baseline and after 12 weeks of pharmacological interventions.
Other: Resting Energy and Exercise Energy Expenditure Assessment
Each participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions.
Other Names:
  • Resting and Exercise Induced Energy Expenditure Test
Other: White Adipose Tissue Biopsy
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.
Other: MRI-PET Scan for Brown Adipose Tissue Volume Assessment
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.
Placebo Comparator: Placebo
The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.
Other: Insulin Sensitivity Test
An assessment of the insulin sensitivity will be done using the Euglycemic Hyperinsulinemic Clamp, at baseline and after 12 weeks of pharmacological interventions.
Other: Resting Energy and Exercise Energy Expenditure Assessment
Each participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions.
Other Names:
  • Resting and Exercise Induced Energy Expenditure Test
Other: White Adipose Tissue Biopsy
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.
Other: MRI-PET Scan for Brown Adipose Tissue Volume Assessment
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.
Other: Placebo
The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.
Other Names:
  • Placebo Arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in BAT volume after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in BAT volume between baseline and post-intervention between two arms.
12 weeks
Change in BAT activity after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in BAT activity between baseline and post-intervention between two arms.
12 weeks
Change in UCP1 gene expression after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in UCP1 gene expression between baseline and post-intervention between two arms.
12 weeks
Change in exercise energy expenditure (EEE) after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in EEE between baseline and post-intervention between two arms.
12 weeks
Change in glycosylated hemoglobin (HbA1C) after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in HbA1C between baseline and post-intervention between two arms.
12 weeks
Change in Body Mass Index (BMI) after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in BMI between baseline and post-intervention between two arms.
12 weeks
Change in Total Cholesterol (TC) after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in TC between baseline and post-intervention between two arms.
12 weeks
Change in low-density lipoprotein-cholesterol (LDL-C) after vericiguat in Black obese individuals with insulin resistance.
Time Frame: 12 weeks
The difference in change in LDL-C between baseline and post-intervention between two arms.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pankaj Arora, MD, FAHA, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 300012681
  • Pending (Clinical Research Information Service)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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