NCT06320951Not yet recruitingPhase 2
VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 13 Mar 2024
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity
- NCT number
- NCT06320951
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 1 Dec 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- BP more than 160/100 mmHg or those treated with three or more classes of antihypertensives
Other illness
- 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)
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.