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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06320951
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Diseases
  • Energy Expenditure
  • Insulin Sensitivity/Resistance
  • Metabolic Disease
  • Metabolism
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Vericiguat 10 MG — DRUG
    The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.
  • Placebo — OTHER
    The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.
  • Insulin Sensitivity Test — OTHER
    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 Assessment — OTHER
    Each participant's Energy Expenditure will be determined using a metabolic cart, at baseline and after 12 weeks of pharmacological interventions.
  • White Adipose Tissue Biopsy — OTHER
    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 Assessment — OTHER
    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 Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: Placebo
    The subject will be randomized, in a double-blind manner to placebo once daily for a period of 12 weeks.

Primary Outcome Measure

Change in insulin sensitivity after vericiguat in Black obese individuals with insulin resistance. [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Alabama at Birmingham· Birmingham, AL

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