Not actual patients.
Proven to help your patients GO LO
Redemplo® (plozasiran) offers significant and sustained triglyceride reduction1
The PALISADE study was a pivotal, randomized, placebo-controlled, double-blind trial in adult patients with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet (≤20 grams of fat per day), where 75 patients were randomized to receive 4 total doses of plozasiran or a matching placebo subcutaneously once every 3 months.1
Redemplo® met its primary efficacy endpoint, achieving a median 80% reduction in fasting triglycerides from baseline at Month 101
Median triglyceride levels dropped below 500 mg/dL as early as Month 1 and were generally sustained during treatment1
Percent Change Collapse
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Significant and Sustained Triglyceride Reduction With Redemplo 25 mg1,3,*
Absolute Values Collapse
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Significant and Sustained Triglyceride Reduction With Redemplo 25 mg1,3,*
*Median fasting triglycerides at baseline were 2008 mg/dL for Redemplo (n=26) and 2053 mg/dL for placebo (n=25). The difference between Redemplo and the placebo group in median percent change in fasting triglyceride levels from baseline to Month 10 was -58.7% (95% CI: -89.6, -27.9; P<0.0001).1
†At Month 10, Redemplo reduced median fasting triglyceride levels to 443 mg/dL.3
In PALISADE, patients taking Redemplo saw a lowered numerical incidence of acute pancreatitis1
All patients in PALISADE responded to Redemplo with triglyceride reductions3
Median fasting triglycerides at baseline were 2008 mg/dL for Redemplo (n=26) and 2053 mg/dL for placebo (n=25).1
PALISADE STUDY DESIGN Collapse
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Redemplo is the only FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS1,2
The PALISADE study was a pivotal, randomized, placebo-controlled, double-blind trial in adult patients with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet (≤20 grams of fat per day), where 75 patients were randomized to receive 4 total doses of Redemplo or a matching placebo subcutaneously once every 3 months.1
PALISADE Study Design1,2
Primary Endpoint1
- Median percent change from baseline in the fasting triglycerides level at Month 10
Multiplicity-Controlled Key Secondary Endpoints1
- Percent change from baseline at Months 10 and 12 (averaged) in fasting triglycerides
- Percent change from baseline at Month 10 in fasting apoC-III
- Percent change from baseline at Month 12 in fasting apoC-III
- Incidence of positively adjudicated events of acute pancreatitis during the randomized period
Plozasiran 25-mg and 50-mg doses resulted in similar triglyceride reductions. Plozasiran 50 mg is not an approved dosing regimen for FCS.1
KEY INCLUSION AND EXCLUSION CRITERIA Collapse
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Key Inclusion and Exclusion Criteria
Adult patients with FCS who were clinically diagnosed or genetically confirmed were evaluated in PALISADE. Inclusion criteria included fasting triglyceride levels of ≥880 mg/dL that were unresponsive to traditional triglyceride-lowering therapies in patients with at least 3 triglyceride measurements >1000 mg/dL AND at least one of the following1,2:
- Recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis OR
- Hospitalizations for severe abdominal pain without other explainable cause OR
- History of childhood pancreatitis OR
- Family history of HTG-induced acute pancreatitis OR
- Prior genetic testing diagnostic of FCS
- Evidence of low lipoprotein lipase activity
Exclusion criteria included uncontrolled diabetes, use of corticosteroids or anabolic steroids, and chronic kidney disease.2
BASELINE CHARACTERISTICS Collapse
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| Redemplo (n=26) | Placebo (n=25) | |
|---|---|---|
| Median fasting triglycerides at baseline | 2008 mg/dL | 2053 mg/dL |
| Clinically diagnosed | 54% | 44% |
| Genetically confirmed | 46% | 56% |
| Diabetes | 15% | 32% |
| History of pancreatitis in the prior 5 years | 54% | 68% |
Across treatment groups, the mean age was 46 years and 49% of patients were male. Seventy-three percent (73%) of patients were White, 21% were Asian, and 5% were reported as other races; 3% identified as Hispanic or Latino ethnicity.1-3
Not actual patients.
Is Redemplo right for your patients?
Convenient dosing—one dose every 3 months1
AP, acute pancreatitis; apoC-III, apolipoprotein C-III; CI, confidence interval; FCS, Familial Chylomicronemia Syndrome; HTG, hypertriglyceridemia.
REFERENCES Collapse
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- Redemplo. Prescribing information. Arrowhead Pharmaceuticals, Inc.; 2025.
- Watts GF. Plozasiran for managing persistent chylomicronemia and pancreatitis risk. New Engl J Med. 2025;392(2):127-137.
- Data on file. Arrowhead Pharmaceuticals, Inc.; 2024.
- Handelsman Y, Jellinger PS, Guerin CK, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the management of dyslipidemia and prevention of cardiovascular disease algorithm – 2020 executive summary. Endocr Pract. 2020;26(10):1196-1224.
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1046-e1081. doi:10.1161/CIR.0000000000000624
Indication & Important Safety Information Collapse
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INDICATION
REDEMPLO® (plozasiran) is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None.
ADVERSE REACTIONS: Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and > 5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction.
Please see full Prescribing Information for REDEMPLO.