RecruitingPhase 1

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of VS-041, how well people tolerate it, and its effects on markers measured in the body. It is for adults age 50 or older with HFpEF, a type of heart failure where the heart still pumps out a normal share of blood.

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 50 or older and have a diagnosis of HFpEF that meets medical guidelines.
  • Have heart failure symptoms that limit physical activity mildly or noticeably (NYHA class II or III).
  • Have a screening heart ultrasound showing signs of heart failure and that the heart pumps out at least 50% of its blood with each beat.
  • Have a high NT-proBNP level, a blood marker linked to heart failure, and a NordicPRO-C6 level of at least 11 ng/mL at screening.
  • Have stayed on the same doses of all heart failure medicines for at least 4 weeks before screening.
  • Weigh at least 110 pounds (50 kg) and have a BMI of at least 18 but below 45. BMI compares weight with height.
  • Men must agree to the birth control rules. Women must not be able to become pregnant.
  • Be able to understand and sign the consent form, and be willing and able to follow the study rules.

Who can't join

  • Be pregnant or breastfeeding, or have a known allergy to VS-041.
  • Have heart or blood vessel disease other than HFpEF, or have had a sudden worsening of heart failure within 30 days before screening.
  • Have a current illness, such as a sudden bacterial or viral infection, or an active long-term infection such as hepatitis B, hepatitis C, or HIV.
  • Have had lung disease within 12 months before screening.
  • Have active or untreated cancer, or have been in remission from a medically significant cancer for less than 5 years. Remission means signs of cancer have decreased or disappeared.
  • Have a history of illegal drug or alcohol misuse or addiction that the study doctor thinks could affect participation.
  • Have taken part in a study of an experimental product within the last 6 months.
  • Have another condition, including a mental health condition, or another reason that the study doctor thinks would prevent joining or completing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Participants must meet all inclusion criteria to be eligible for trial participation. 1. Males or females ≥ 50 years of age at the time of signing the informed consent. 2. Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria 3. NYHA Functional Class II or III 4. LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure 5. Elevated NT-proBNP at Screening 6. NordicPRO-C6™ ≥ 11 ng/mL at Screening. 7. Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening. 8. Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to \< 45 kg/m2. 9. Males must agree to the contraception requirements and females must be of non-childbearing potential 10. Able to understand and willing to sign a written informed consent form (ICF). 11. Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol. Exclusion Criteria: 1. Female trial participant who is pregnant or breastfeeding. 2. Known hypersensitivity to VS-041. 3. Cardiovascular disease other than HFpEF 4. Active intercurrent illness such as acute bacterial or viral infection. 5. History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation. 6. Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening. 7. Acute decompensated HF within 30 days of Screening 8. Lung disease within 12 months prior to Screening 9. History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years. 10. History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol. 11. Have participated within the last 6 months in a clinical study involving an investigational product. 12. Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.

Study sites (21)

AR

CA

FL

IL

LA

MO

NC

NJ

NY

OH

OK

TX