HeartPhase 1NCT07219511
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
A Phase 1 study testing VS-041 in people with Heart and Heart Failure With Preserved Ejection Fraction (HFPEF), run by Vasa Therapeutics at 21 sites in United States.
Trial summary
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart, Heart Failure With Preserved Ejection Fraction (HFPEF)
- What is being tested?
- VS-041
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 21 sitesUnited States
- Study dates
- 4 Nov 2025to Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all inclusion criteria to be eligible for trial participation.
- Males or females ≥ 50 years of age at the time of signing the informed consent.
- Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
- NYHA Functional Class II or III
- LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure
- Elevated NT-proBNP at Screening
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- NordicPRO-C6™ ≥ 11 ng/mL at Screening.
- Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
- Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to < 45 kg/m2.
- Males must agree to the contraception requirements and females must be of non-childbearing potential
- Able to understand and willing to sign a written informed consent form (ICF).
- Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.
Who cannot join
- Female trial participant who is pregnant or breastfeeding.
- Known hypersensitivity to VS-041.
- Cardiovascular disease other than HFpEF
- Active intercurrent illness such as acute bacterial or viral infection.
- History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
- Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening.
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- Acute decompensated HF within 30 days of Screening
- Lung disease within 12 months prior to Screening
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
- 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.
- Have participated within the last 6 months in a clinical study involving an investigational product.
- Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Ash Research Clinic
Brick, New Jersey, 08724
Erie County Medical Center
Buffalo, New York, 14215
Eagle Clinical Research
Chicago, Illinois, 60621
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical Center
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27710
Chicago Medical Research
Hazel Crest, Illinois, 60429
New Generation of Medical Research
Hialeah, Florida, 33016
National Institute of Clinical Research
Huntington Beach, California, 92648
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204
Amavita Health
North Miami Beach, Florida, 33169
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Broward Research Center
Pembroke Pines, Florida, 33024
Methodist Medical Center of Illinois
Peoria, Illinois, 61606
FOMAT
Santa Maria, California, 93454
Louisiana Heart Center
Slidell, Louisiana, 70458
Washington University
St Louis, Missouri, 63110
LinQ Research, LLC
Tomball, Texas, 77375
Invivocure LLC
Van Nuys, California, 91405
Wake Forest
Winston-Salem, North Carolina, 27157
About this study
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
- Being tested
- VS-041, Placebo
- Keywords
- Heart Failure with Preserved Ejection Fraction, HFpEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-041Drug
VS-041 high dose, VS-041 low dose or Placebo tablet BID
PlaceboOther
Placebo to match VS-041
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Low Dose VS-041 | Experimental | Not described Receives: Drug: VS-041 |
| High Dose VS-041 | Experimental | Not described Receives: Drug: VS-041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant incidence of treatment-emergent adverse events (TEAEs)
To evaluate the safety and tolerability of VS-041 in participants with HFpEF
Measured: From Baseline to Day 28
Change from baseline over time in serum NordicPRO-C6
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Measured: From Baseline to Day 28
Change from baseline over time in serum endotrophin
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Measured: From Baseline to Day 28
Change from baseline over time in serum NT-proBNP
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Measured: From Baseline to Day 28
Secondary outcomes (2)
Pharmacokinetic profiles and parameters derived for VS-041 - Tmax
To assess PK of twice-daily VS-041 in participants with HFpEF
Measured: From Baseline to Day 28
Pharmacokinetic profiles and parameters derived for VS-041 - Cmax
To assess PK of twice-daily VS-041 in participants with HFpEF
Measured: From Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start4 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vasa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219511
- Sponsor's protocol ID
- VS-041-102
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided