Not yet taking people in United StatesPhase 2

Tests vericiguat for heart and metabolic health in adults with obesity

Tests vericiguat against placebo in Black adults with obesity and insulin resistance.

Key facts

Who runs it: University of Alabama at Birmingham
Where: Birmingham, United StatesSee the site
Trial code: NCT06320951
Registry title: VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
Status: Not yet recruiting
Phase: Phase 2
People taking part: 200 people, planned
Starts: 1 Dec 2026
Expected to end: 30 Apr 2029
Type of study: Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested: Vericiguat 10 MG
Placebo
Insulin Sensitivity Test
Resting Energy and Exercise Energy Expenditure Assessment
White Adipose Tissue Biopsy
MRI-PET Scan for Brown Adipose Tissue Volume Assessment
Record updated: 23 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who identify as African-American or Black, are obese, and have insulin resistance. It tests vericiguat against placebo for 12 weeks.

Age: 18 to 80 years
Sex: Women and men can join.
Disease stage: Obesity with BMI of 30 kg/m2 or more and insulin resistance with HOMA-IR of 2.5 or more. Blood pressure 120-160/80-100 mmHg.
Earlier treatment: People treated for high blood pressure can join if they take up to two classes of blood pressure drugs and stop them for 1 week before the trial. People who have taken diabetes drugs cannot join.
Biomarker or test result: HOMA-IR of 2.5 or more.

Main reasons for not taking part

Pregnant or breastfeeding women, or women who can become pregnant and use no acceptable birth control
Past or present cardiovascular disease, such as stroke, heart attack, heart failure or angina
History of diabetes, or high blood sugar tests, or past diabetes drugs
BMI above 45 kg/m2, or blood pressure above 160/100 mmHg
Kidney, liver, psychiatric or anemia problems as set out in the record, or being unable to exercise on a treadmill

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

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 take part

BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives
Have any past or present history of cardiovascular diseases (stroke, myocardial infarction, heart failure, transient ischemic attack, angina, seizure or cardiac arrhythmia)
Significant psychiatric illness (assessed using validated MINI questionnaire)
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
Anemia (men, Hb<13 g/dL; women, Hb <12 g/dL)
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)
BMI >45 kg/m2
Inability to exercise on a treadmill

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in United States

University of Alabama at BirminghamBirmingham, United StatesContact: Nehal Vekariya, MSNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

Experimental: VericiguatTreatment being tested
The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.
Treatment: Vericiguat 10 MG, Insulin Sensitivity Test, Resting Energy and Exercise Energy Expenditure Assessment, White Adipose Tissue Biopsy, and MRI-PET Scan for Brown Adipose Tissue Volume Assessment
PlaceboPlacebo, for comparison
The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.
Treatment: Placebo, Insulin Sensitivity Test, Resting Energy and Exercise Energy Expenditure Assessment, White Adipose Tissue Biopsy, and MRI-PET Scan for Brown Adipose Tissue Volume Assessment