A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorVasa Therapeutics
About this trial
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VS-041
DrugVS-041 high dose, VS-041 low dose or Placebo tablet BID
Placebo
Other interventionPlacebo to match VS-041
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Low Dose VS-041Experimental treatment 1 intervention
Group C: High Dose VS-041Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participant incidence of treatment-emergent adverse events (TEAEs)
To evaluate the safety and tolerability of VS-041 in participants with HFpEF
Time frame
From Baseline to Day 282
Change from baseline over time in serum NordicPRO-C6
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Time frame
From Baseline to Day 283
Change from baseline over time in serum endotrophin
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Time frame
From Baseline to Day 284
Change from baseline over time in serum NT-proBNP
To evaluate the impact of VS-041 on key biomarkers in participants with HFpEF
Time frame
From Baseline to Day 28Secondary outcomes
1
Pharmacokinetic profiles and parameters derived for VS-041 - Tmax
To assess PK of twice-daily VS-041 in participants with HFpEF
Time frame
From Baseline to Day 282
Pharmacokinetic profiles and parameters derived for VS-041 - Cmax
To assess PK of twice-daily VS-041 in participants with HFpEF
Time frame
From Baseline to Day 28Sponsors and contacts
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Source ClinicalTrials.gov