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New treatment option for Severe Hypertriglyceridemia
Official title Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
ClinicalTrials.gov ID: NCT06880770
What this study is testing
What is Plozasiran?
Plozasiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for severe hypertriglyceridemia.
Also referred to as ARO-APOC3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females
- 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 Screening.
- Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
- Screening hemoglobin A1c (HbA1c) ≤ 9.5%
You likely can't join if
- Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1...
- Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever...
- AP ≤ 4 weeks prior to Randomization/Day 1
- Body mass index (BMI) \> 45 kg/m\^2
- Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)
- Planned coronary intervention (e.g. stent placement or heart bypass) during the study
See the full eligibility criteria
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females
- 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 Screening.
- 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 care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)
- 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 Randomization/Day 1
- Body mass index (BMI) \> 45 kg/m\^2
- Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)
- Planned coronary intervention (e.g. stent placement or heart bypass) during the study
- History of arterial revascularization within 16 weeks of Screening
- 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...
- 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 Inclusion/Exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Santa Clarita, California, United States
- New Haven, Connecticut, United States
- Springfield, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- North Platte, Nebraska, United States
- Greensboro, North Carolina, United States
- Wilmington, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Mesquite, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Ramos Mejía, Buenos Aires, Argentina
- Córdoba, Córdoba Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
+ 56 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Santa Clarita, California, United States; New Haven, Connecticut, United States; Springfield, Illinois, United States; Indianapolis, Indiana, United States; Kansas City, Kansas, United States and 70 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.