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

NCT07219511 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VS-041-102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

Heart; Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart Failure with Preserved Ejection Fraction; HFpEF

Outcome Measures

Primary Outcomes (4)

• Participant incidence of treatment-emergent adverse events (TEAEs)

  To evaluate the safety and tolerability of VS-041 in participants with HFpEF

  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

  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

  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

  From Baseline to Day 28

Secondary Outcomes (2)

• Pharmacokinetic profiles and parameters derived for VS-041 - Tmax

  From Baseline to Day 28

• Pharmacokinetic profiles and parameters derived for VS-041 - Cmax

  From Baseline to Day 28

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Low Dose VS-041

EXPERIMENTAL

Drug: VS-041

High Dose VS-041

EXPERIMENTAL

Drug: VS-041

Interventions

VS-041 DRUG

VS-041 high dose, VS-041 low dose or Placebo tablet BID

High Dose VS-041; Low Dose VS-041

Placebo OTHER

Placebo to match VS-041

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vasa Therapeutics: lead

Study Sites (21)

Cardiology and Medicine Clinic

Little Rock, Arkansas, 72204, United States

RECRUITING

National Institute of Clinical Research

Huntington Beach, California, 92648, United States

RECRUITING

FOMAT

Santa Maria, California, 93454, United States

RECRUITING

Invivocure LLC

Van Nuys, California, 91405, United States

RECRUITING

New Generation of Medical Research

Hialeah, Florida, 33016, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Amavita Health

North Miami Beach, Florida, 33169, United States

RECRUITING

Broward Research Center

Pembroke Pines, Florida, 33024, United States

RECRUITING

Eagle Clinical Research

Chicago, Illinois, 60621, United States

RECRUITING

Chicago Medical Research

Hazel Crest, Illinois, 60429, United States

RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61606, United States

NOT YET RECRUITING

Louisiana Heart Center

Slidell, Louisiana, 70458, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Ash Research Clinic

Brick, New Jersey, 08724, United States

RECRUITING

Erie County Medical Center

Buffalo, New York, 14215, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75231, United States

RECRUITING

LinQ Research, LLC

Tomball, Texas, 77375, United States

RECRUITING

Central Study Contacts

Clinical Team

CONTACT

760-230-3398; Clinical@Vasatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 22, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (21)