VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals

This study is looking into whether a drug called vericiguat 10 mg can improve heart and metabolism health in Black adults who are obese and have insulin resistance. Insulin resistance means your body doesn't respond well to insulin, which can lead to health problems. Researchers believe that vericiguat might help by boosting a natural process in the body called the cyclic guanosine monophosphate (cGMP) signaling pathway. This pathway is important for how your body uses energy and sugar. The study will compare vericiguat to a placebo (a pill with no medicine) over 12 weeks. They will measure changes in insulin sensitivity and how much energy your body uses at rest. You might be able to join if you are a Black adult, aged 18-80, with a BMI of 30 or higher, and have insulin resistance. The study aims to enroll 200 participants, but its current status is unclear.

Study design: This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either vericiguat or a placebo, and neither you nor your doctor will know which you are receiving. The study plans to enroll 200 participants.
What's involved: You would take vericiguat 10 mg or a placebo once daily for 12 weeks. You would also have tests for insulin sensitivity and energy expenditure at the beginning and end of the 12 weeks. Some participants may also have a fat tissue biopsy.
Compensation: Not stated in the trial record.
Follow-up: Your insulin sensitivity and energy expenditure will be measured after 12 weeks of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Not Yet Recruiting

PHASE2Ages 18–80InterventionalTreatment

University of Alabama at Birmingham

~200 participants

Updated 2026-01-23 on ClinicalTrials.gov

What's tested:Vericiguat 10 MGPlaceboInsulin Sensitivity TestResting Energy and Exercise Energy Expenditure AssessmentWhite Adipose Tissue BiopsyMRI-PET Scan for Brown Adipose Tissue Volume Assessment

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance.

Measured over 12 weeks

+1 more outcome measured

Conditions

Cardiovascular Diseases

Insulin Sensitivity/Resistance

Metabolic Disease

Metabolism

Energy Expenditure

Obesity

Where it's being run

1 sites across 1 states

Alabama1

Study leadership

Pankaj Arora, MD, FAHA · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Nehal Vekariya, MS

[email protected]

2059347173

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance.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.12 weeks
The difference in change in REE between baseline and post-intervention between two arms.

Trialytics