Actively Recruiting
Phase 1 Study to Evaluate Safety and Biomarkers of VS-041 in Adults 50 and Older with Heart Failure with Preserved Ejection Fraction HFpEF
Led by Vasa Therapeutics · Updated on 2026-04-09
42
Participants Needed
21
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction HFpEF, a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drugs safety and biological effects.
CONDITIONS
Brief Title
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 50 years or older at the time of consent
- Diagnosis of HFpEF by European or American heart society criteria
- New York Heart Association Functional Class II or III
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography at screening
- Elevated NT-proBNP biomarker at screening
- NordicPRO-C6 level of 11 ng/mL or higher at screening
- Stable dose of all heart failure medications for at least 4 weeks before screening
- Body weight at least 110 lbs (50 kg) and BMI between 18 and less than 45 kg/m2
- Males must agree to contraception requirements; females must be of non-childbearing potential
- Ability to understand and willing to sign informed consent
- Willingness and ability to follow trial procedures and restrictions
You will not qualify if you...
- Female participants who are pregnant or breastfeeding
- Known allergy or hypersensitivity to VS-041
- Cardiovascular diseases other than HFpEF
- Active infections like acute bacterial or viral illness
- History of illicit drug or alcohol abuse that may affect participation
- Active chronic viral infections such as Hepatitis B, Hepatitis C, or HIV at screening
- Acute worsening of heart failure within 30 days before screening
- Lung disease diagnosed within 12 months prior to screening
- History of active or untreated cancer or remission less than 5 years
- Psychiatric or other conditions that may prevent following the protocol
- Participation in another clinical trial with investigational product within last 6 months
- Any other condition that may prevent safe participation as judged by the investigator
Research Team
C
Clinical Team
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