VS-041 for Heart Failure

Recruiting at 21 trial locations

Overseen By Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vasa Therapeutics

Disqualifiers: Cardiovascular disease, Lung disease, Malignancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VS-041 to assess its safety and effects on individuals with a specific type of heart failure known as HFpEF (Heart Failure with Preserved Ejection Fraction). Researchers aim to understand the safety and tolerability of this treatment by comparing different doses of VS-041 to a placebo (a non-active treatment). The trial seeks adults diagnosed with HFpEF who have experienced heart failure hospitalizations and are on stable heart medications. Participants should have a history of frequent heart-related hospital visits and meet certain health criteria. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of your heart failure medications for at least 4 weeks before starting. It doesn't specify stopping other medications, so you may not need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VS-041 has been tested for safety and tolerability. One study with healthy volunteers examined how the body absorbs VS-041 and found it to be generally well-tolerated, with no major safety concerns. Another study indicated that VS-041 reduced heart-related issues in early tests, suggesting positive safety outcomes.

In this early-phase trial, the primary goal is to ensure VS-041's safety for humans. Early trials focus on safety, so researchers will closely monitor any side effects. At this stage, the treatment is being tested to confirm its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about VS-041 because it offers a fresh approach to treating heart failure. While most treatments focus on managing symptoms or improving heart function indirectly, VS-041 is designed to target the underlying molecular pathways responsible for heart failure. This could potentially lead to more effective and long-lasting results. Additionally, VS-041 is available in both high and low doses, providing flexibility in treatment and the possibility to tailor therapy to individual patient needs. This innovative approach has the potential to transform how we manage heart failure, offering hope for better patient outcomes.

What evidence suggests that VS-041 might be an effective treatment for heart failure?

Research has shown that VS-041 could help treat a type of heart failure known as HFpEF. In studies using a specific rat model for high blood pressure and HFpEF, VS-041 reduced heart tissue scarring and improved heart relaxation, suggesting it might aid in easier blood pumping. These early results are promising but come from animal studies. This trial will test both high and low doses of VS-041 in human participants to assess its effectiveness and safety. More research is needed to determine if it works similarly in people. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 50 with heart failure who have a specific level of heart function and biomarkers indicating their condition. They must not have a history of drug abuse, certain infections, or recent participation in other trials. Women must not be pregnant or breastfeeding, and men agree to contraception requirements.

Inclusion Criteria

NYHA Functional Class II or III

Elevated NT-proBNP at Screening

NordicPRO-C6™ ≥ 11 ng/mL at Screening

Exclusion Criteria

Known hypersensitivity to VS-041

History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation

Serologic evidence of Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV) at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VS-041 or placebo to evaluate safety, tolerability, and biomarker changes

4 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• VS-041

Trial Overview The trial tests the safety and effects of VS-041 on patients with HFpEF compared to a placebo. It aims to understand how well VS-041 is tolerated and its impact on various biological markers related to heart failure.

How Is the Trial Designed?

Group I: Low Dose VS-041 Experimental Treatment 1 Intervention

Group II: High Dose VS-041 Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vasa Therapeutics

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219511

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

2. ahajournals.org ahajournals.org/doi/10.1161/circ.146.suppl_1.13724

Abstract 13724: Development of VS-041 as a Precision ... VS-041 demonstrated robust efficacy in Dahl Salt Sensitive rat model of hypertension and HFpEF after dosing at 25 or 50 mg/kg PO for 5 wks in a ...

3. synapse.patsnap.com synapse.patsnap.com/blog/vasa-therapeutics-initiates-phase-1-trial-of-vs-041-for-heart-failure-treatment

Vasa Therapeutics Initiates Phase 1 Trial of VS-041 for ... In preclinical HFpEF models, VS-041 significantly reduces cardiac fibrosis and improves diastolic heart function. The compound also suppresses ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37072105/

Myeloperoxidase Inhibition in Heart Failure With Preserved ... Conclusions: AZD4831 inhibited myeloperoxidase and was well tolerated in patients with heart failure and left ventricular ejection fraction of 40% or greater.

5. ahajournals.org ahajournals.org/doi/abs/10.1161/circ.150.suppl_1.4137688

Abstract 4137688: Inhibition of Cardiac Fibrosis and Pro- ... Previously, VS-041 demonstrated robust efficacy in the Dahl Salt Sensitive rat model of hypertension and HFpEF, improving diastolic function and ...

6. ahajournals.org ahajournals.org/doi/abs/10.1161/circ.152.suppl_3.4364307

Abstract 4364307: VS-041, a narrow-spectrum, matrix ... VS-041 also inhibits formation of endotrophin, a collagen 6α–derived peptide, associated with increased risk of poor outcomes (heart failure ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12572806/

Prevention of cardiovascular events in heart failure with mildly ... The primary outcome was the composite of time to cardiovascular death or heart failure (HF) hospitalization. One-stage approach using stratified ...

8. prnewswire.com prnewswire.com/news-releases/vasa-therapeutics-receives-fda-ind-clearance-to-advance-novel-small-molecule-vs-041-for-the-treatment-of-heart-failure-with-preserved-ejection-fraction-hfpef-302581657.html

Vasa Therapeutics Receives FDA IND Clearance to ... VS-041 robustly reduces cardiac fibrosis and significantly improves diastolic heart functions in preclinical HFpEF models. VS-041 is ...

9. isrctn.com isrctn.com/ISRCTN15814719

ISRCTN15814719: A study in healthy volunteers to look at ... A study in healthy volunteers to look at the safety and tolerability of the test medicine VS-041 and how it is taken up by the body when given as single and ...