A Phase 2 interventional study of Xolatryp and Placebo in Myocardial Infarction, Reperfusion Injury and AMI, sponsored by Nyrada Pty Ltd. Recruiting at 8 sites in Australia. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Nyrada Pty Ltd · Phase 2, Interventional, and Treatment
This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study.
Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days.
Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30.
Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 300 is above the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Nyrada Pty Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within ST Elevation Myocardial Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Infarction. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After randomization, patients receive primary PCI and standard therapy. Patients assigned to the experimental arm also receive Xolatryp, administered as a single, continuous intravenous infusion (i.v.) for 6 hours.
Drug: Xolatryp
After randomization, patients receive primary PCI and standard therapy. Patients assigned to the placebo arm also recieve a placebo comparator, administered as a single, continuous intravenous (i.v.) infusion for 6 hours.
Drug: Placebo
Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours.
Patients assigned to the placebo comparator arm receive 0.1% of 20% Intralipid in 0.9% normal saline, administered via continuous intravenous (i.v.) infusion for 6 hours.
Incidence of Adverse Events
Incidence of adverse events (AE) and serious adverse events (SAE) overall. Incidence of AEs and SAEs deemed related to Xolatryp. Incidence of AEs and SAEs deemed cardiac related.
Time frame: From enrollment up to and including follow-up assessments on Day 30 (end of study)
Plasma concentration of Xolatryp during the infusion
Blood sample(s) taken at 4 hours post the start of infusion
Time frame: Blood samples will be taken for pharmacokinetic (PK) assessment at 4 hours after start of infusion. Where feasible, a sample should be taken at 10 minutes into the infusion.
ST-segment elevation resolution
Comparison between treatment groups of ST-segment elevation resolution calculated from pre-PCI ECG and first post procedural ECG
Time frame: pre-PCI ECG and first post procedural ECG
Cardiac Injury Biomarkers
Plasma Troponin I levels calculated as area under the curve (AUC) over 48 hours post PCI
Time frame: 48 hours post PCI
Incidence of Arrhythmias
Comparison of number of arrhythmias of interest recorded on telemetry (48 hours) between patients treated with Xolatryp vs Placebo. Arrhythmias of interest are sustained ventricular tachycardia (VT), non-sustained ventricular tachycardia (NSVT), and high degree- atrioventricular (AV) block.
Time frame: Telemetry to 48 hours
Cardiac Infarct Size
Volumetric quantification comparison between treatment groups of cardiac infarct size parameters: Acute myocardial infarct size indexed to left ventricular mass, and Myocardial Salvage Index (MSI).
Time frame: Day 5 (+/- 2 days)
Left Ventricular End-diastolic volume
Left Ventricular End-diastolic volume measurement from CMR will be used to assess cardiac function on Day 5 (+/- 2 days)
Time frame: Day 5
Patient Reported Outcomes (PRO) Questionnaire
36-Item Short Form Health Survey (SF-36)
Time frame: Day 30 (end of study)
Left Ventricular Ejection fraction
Left ventricular ejection fraction measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI
Time frame: Day 2 and Day 30
Left Ventricular End-systolic Volume
Left Ventricular Volume measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI
Time frame: Day 2 and Day 30
Left Ventricular Function
Left Ventricular Function measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI
Time frame: Day 2 and Day 30
Fractional shortening
Fractional shortening will be assessed via echocardiogram prior to discharge and at Day 30.
Time frame: Day 2 and 30
Started Jul 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.
Of 31 phase 2 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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ST Elevation Myocardial Infarction →
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