NP202 for Treatment of Post -STEMI Left Ventricular Systolic Dysfunction
A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Adults Who Have Left Ventricular Systolic Dysfunction Following Myocardial Infarction
  • Phase

    Phase 2
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    np202 ...
  • Study Participants

NP202 is an experimental drug being developed by Armaron Bio Pty Ltd for potential use as a treatment for people after they have had a heart attack (MI).
After someone has a MI, their heart 'remodels', which means that it changes in size and shape. This damage can lead to it being weaker and less efficient, and ultimately to major heart problems. There are some drugs currently available which help prevent remodelling and are used for treatment post-MI. However, there is still a high rate of remodelling and major heart problems in people post-MI. NP202 works in a different way to the drugs that are currently approved, and has been shown in animal studies to prevent post-MI remodelling.

This study will assess NP202 versus placebo on remodelling over a 3 month treatment period, with 1 month follow up
Study Started
Oct 31
Primary Completion
Dec 31
Study Completion
Feb 28
Last Update
Jun 28

Drug NP202


Other Placebo


  • Other names: Microcellulose

NP202 Experimental

1000mg oral NP202 daily for 90 days

Placebo Placebo Comparator

Oral placebo daily for 90 days


Inclusion Criteria:

Have had a confirmed ST elevation myocardial infarction (STEMI) in the previous 5 days, which met all of the following criteria;

≥ 0.2mV ST elevation in 2 or more V1 - V6 leads with presentation in a maximum of 12 hours of onset of symptoms
Troponin levels >10 x upper limit of normal (ULN) at the site's local laboratory.
Successful revascularisation by Percutaneous Coronary Intervention (PCI)
Have left ventricular dysfunction post STEMI as evidenced by left ventricular ejection fraction (LVEF) ≤40% confirmed by echocardiogram at screening.
Are receiving guideline-directed medical therapy for acute MI and post-MI left ventricular (LV) dysfunction according to national cardiology society/heart association STEMI guidelines.

Exclusion Criteria:

Known cardiomyopathy or heart failure prior to MI.
Cardiogenic shock and/or systolic blood pressure <85mmHg at Screening.
Clinical history of ejection fraction ≤40% prior to this MI, or multiple prior MIs.
Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or cyclooxygenase-2 (COX-2) inhibitors in the past month.
Presence of device/hardware incompatible with MRI
Estimated glomerular filtration rate (eGFR) <30ml/min
Liver function tests 3 x ULN due to non-cardiac disease
Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
No Results Posted