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Study to Evaluate Plozasiran in Adults with Hypertriglyceridemia (MUIR-3 Study)
EU CTIS ID: 2023-509302-30-00
What this study is testing
To demonstrate the efficacy of plozasiran on reducing fasting serum TG levels
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
- Established diagnosis of HTG and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L)
- Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
- Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤9.0%
- Willing to follow diet counseling and maintain a stable low-fat diet
You likely can't join if
- Use of any hepatocyte-targeted siRNA that targets lipids and/or TGs within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.
- Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer.
- Acute pancreatitis within 4 weeks prior to screening (S1)
- Body mass index (BMI) >45 kg/m2
See the full eligibility criteria
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
- Established diagnosis of HTG and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L)
- Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
- Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤9.0%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Subjects must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.
- Use of any hepatocyte-targeted siRNA that targets lipids and/or TGs within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.
- Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer.
- Acute pancreatitis within 4 weeks prior to screening (S1)
- Body mass index (BMI) >45 kg/m2
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Canada
- United Kingdom
- South Africa
- Australia
- United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Canada; United Kingdom; South Africa; Australia; United States. 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 EU CTIS; the study team decides eligibility.