Vericiguat for Insulin Resistance

(VITAL-IMPACT Trial)

Overseen By Naman Shetty, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must not be taking: Antidiabetics, Antihypertensives

Disqualifiers: Cardiovascular diseases, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

If you are taking up to two classes of blood pressure medications, you may need to stop them for one week before joining the trial. The protocol does not specify other medication restrictions.

Research Team

Pankaj Arora, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for Black individuals who are obese and have insulin resistance. Participants will undergo various tests, including MRI-PET scans, tissue biopsies, and energy expenditure assessments. People with allergies or other metabolic diseases may not be eligible.

Inclusion Criteria

Willing to adhere to study protocol

BMI ≥ 30 kg/m2

Self-identified race/ethnicity as African-American or Black

Exclusion Criteria

My blood pressure is over 160/100 mmHg or I take three or more blood pressure medications.

I have diabetes or my blood sugar/HbA1C levels are high.

I am not pregnant, breastfeeding, and I use effective birth control or practice abstinence.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vericiguat or placebo in a double-blind manner to assess improvements in insulin sensitivity and energy expenditure

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vericiguat

Trial Overview The study is testing vericiguat, a drug that targets the cGMP pathway believed to improve heart health and metabolism in obese Black individuals with insulin resistance. It's compared against a placebo over 12 weeks to see if it affects body fat, energy use, and insulin sensitivity.

Participant Groups

Group I: Experimental: Vericiguat Experimental Treatment 5 Interventions

The subject will be randomized, in a double-blind manner to vericiguat 10 mg once daily for a period of 12 weeks.

Group II: Placebo Placebo Group 5 Interventions

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

Vericiguat is already approved in United States, European Union for the following indications:

Approved in United States as Verquvo for:

• Heart failure

Approved in European Union as Verquvo for:

• Chronic heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+