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Study to Evaluate Plozasiran in Adults with Severe Hypertriglyceridemia at high risk of Acute Pancreatitis (SHASTA-5 Study)
EU CTIS ID: 2024-518206-40-00
What this study is testing
To evaluate the efficacy of plozasiran on adjudicated Acute Pancreatitis (AP) events during double-blind treatment period
- 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 SHTG and prior documented evidence (medical history) of fasting TG levels of ≥880 mg/dL (≥10 mmol/L)
- Fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected during the screening period
- Documented evidence of at least 1 prior AP event (according to the clinical diagnosis per medical records) not attributed to other etiologies (eg, gallstones, alcohol), occurring within the last 5 years (60 months) prior to screening
- Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤9.5%
You likely can't join if
- Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides 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 ≤ 4 weeks prior to Randomization/Day 1.
- Body mass index >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 SHTG and prior documented evidence (medical history) of fasting TG levels of ≥880 mg/dL (≥10 mmol/L)
- Fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected during the screening period
- Documented evidence of at least 1 prior AP event (according to the clinical diagnosis per medical records) not attributed to other etiologies (eg, gallstones, alcohol), occurring within the last 5 years (60 months) prior to screening
- Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤9.5%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Participants must be on standard of care lipid- and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)
- Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides 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 ≤ 4 weeks prior to Randomization/Day 1.
- Body mass index >45 kg/m2
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- China
- Mexico
- Argentina
- Jordan
- Serbia
- Singapore
- United States
- United Arab Emirates
- Korea, Republic of
- Brazil
- Oman
- Saudi Arabia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; China; Mexico; Argentina; Jordan; Serbia and 7 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 EU CTIS; the study team decides eligibility.