Assessing STM-01 for heart failure with preserved ejection fraction

A Phase 1, Open Label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

This study is testing a new drug called STM-01 to see if it is safe for people with heart failure that has preserved ejection fraction.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Secretome Therapeutics (Industry-sponsored)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT06560762 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study evaluates the safety and tolerability of STM-01 in participants diagnosed with heart failure with preserved ejection fraction (HFpEF). The study involves multiple ascending doses of the investigational drug to determine its effects on patients who have stable NYHA Class II or III heart failure. Participants must have a documented history of heart failure and be on stable standard care therapy. The study aims to gather preliminary data on the drug's safety profile in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with stable NYHA Class II or III heart failure and an ejection fraction of 50% or greater.

Not a fit: Patients with prior diagnoses of hypertrophic cardiomyopathy or other specific cardiac conditions causing HFpEF may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from HFpEF.

How similar studies have performed: While there have been studies on heart failure treatments, the specific approach of using STM-01 in HFpEF is novel and has not been extensively tested.

Eligibility criteria

Major Inclusion Criteria:

* Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history.
* Documented prior objective evidence of heart failure
* Screening ejection fraction ≥50%.
* Adequate bone marrow reserve and organ function at the Screening
* Receiving standard of care heart failure therapy at stable doses for at least 30 days prior to Screening.

Major Exclusion Criteria:

* Participant in any other study and has received any other investigational drug within 30 days prior to screening or 5-half-lives, whichever is longer, or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments.
* Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy.
* Persistent or permanent atrial fibrillation and is not therapeutically anticoagulated for at least the 4 weeks prior to the initial screening visit or is not adequately rate controlled within 6 months prior to informed consent according to investigator discretion.
* Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study.

Where this trial is running

Chicago, Illinois and 1 other locations

• Northwestern Medicine — Chicago, Illinois, United States (Not_yet_recruiting)
• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Malika Pasha

Conditions Heart Failure With Preserved Ejection Fraction