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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2029

Conditions
Cardiovascular DiseasesInsulin Sensitivity/ResistanceMetabolic DiseaseMetabolismEnergy ExpenditureObesity
Interventions
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

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

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.

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER