About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

1
University of Alabama at Birmingham35294, BirminghamAlabama, United States

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor