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
- Are there results?
- Not yet: the study is under way
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
Show all 12Show fewer
- 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.
Show all 12Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT07219511
- Acronym / sponsor ID
- VS-041-102
- Keywords
- Heart Failure with Preserved Ejection Fraction, HFpEF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vasa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Low Dose VS-041 | Experimental | Drug: VS-041 |
| High Dose VS-041 | Experimental | Drug: VS-041 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VS-041VS-041 high dose, VS-041 low dose or Placebo tablet BID | Drug | High Dose VS-041, Low Dose VS-041 |
| PlaceboPlacebo to match VS-041 | Other | Placebo |
Primary outcome
Participant incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline to Day 28
To evaluate the safety and tolerability of VS-041 in participants with HFpEF
Change from baseline over time in serum NordicPRO-C6
Time frame: From Baseline to Day 28
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Change from baseline over time in serum endotrophin
Time frame: From Baseline to Day 28
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Change from baseline over time in serum NT-proBNP
Time frame: From Baseline to Day 28
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
2 secondary outcomes
Pharmacokinetic profiles and parameters derived for VS-041 - Tmax
Time frame: From Baseline to Day 28
Pharmacokinetic profiles and parameters derived for VS-041 - Cmax
Time frame: From Baseline to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Heart
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant incidence of treatment-emergent adverse events (TEAEs) (time frame: From Baseline to Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.