Testing Plozasiran for severe hypertriglyceridemia
Official title: Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
- Phase 3
- 2 groups
- One site, in Montreal
- Recruiting
Interventions
- Medication
Plozasiran
ARO-APOC3 injection
- Medication
Placebo
sterile normal saline (0.9% NaCl)
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Research Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L)
- +Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
- +Screening hemoglobin A1c (HbA1c) ≤ 9.5%
- +Willing to follow diet counseling and maintain a stable low-fat diet
- +Must be on standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →)
- +Males, or nonpregnant (who do not plan to become pregnant) nonlactating females
Exclusion
- −Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1, except inclisiran.
- −Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.
- −AP ≤ 4 weeks prior to RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →/Day 1
- −Body mass index (BMI) \> 45 kg/m\^2
- −Planned coronary intervention (e.g. stent placement or heart bypass) during the study
- −History of arterial revascularization within 16 weeks of ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −History of acute coronary syndrome event within 24 weeks of Screening
- −Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening
- −Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study
- −History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening
- −New York Heart Association Class III-IV heart failure or last known ejection fraction of \< 30%
- −Current diagnosis of nephrotic syndrome
- −Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m\^2
- −Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× Upper Limit of Normal (ULN) at Screening
- −Note: Additional InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply per protocolProtocolThe detailed plan a study must follow.Read more →
- −Any planned bariatric surgery or similar procedures to induce weight lost starting at consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → through End of Study (EOS)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Plozasiran.
Registry label: A: Plozasiran Injection
Group B receives PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 288 people.
The study is currently expected to finish around June 2029.
The main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to end of Double BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Treatment Period compared to placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → (Approximate Maximum 50 Months)].
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug) — measured over RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to end of Double BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Treatment Period compared to placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → (Approximate Maximum 50 Months)].
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06880770 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PlozasiranDrug
ARO-APOC3 injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
sterile normal saline (0.9% NaCl)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it — alongside the other treatment that group is given.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → up to end of Double BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Treatment Period compared to placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → (Approximate Maximum 50 Months)].
The study as a whole is currently expected to finish around 2029-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 288 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; New York, New York, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.
Other Sites (3)
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.