Recent Updates
Recently added Catalysts

Plozasiran

Phase 3

Severe Hypertriglyceridemia | Small molecule | Other |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,045
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06880770Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute PancreatitisPHASE3 RECRUITING 288 — — Apr 24, 2025Jun 1, 2029May 6, 202683 United States, Argentina +14
NCT06347016Study of Plozasiran in Adults With Severe HypertriglyceridemiaPHASE3 ACTIVE NOT_RECRUITING 311 — — Jul 23, 2024Sep 1, 2026Oct 24, 2025149 United States, Argentina +14
NCT06347003Study of Plozasiran (ARO-APOC3) in Adults With Severe HypertriglyceridemiaPHASE3 ACTIVE NOT_RECRUITING 446 — — Jul 22, 2024Sep 1, 2026Oct 27, 2025196 United States, Argentina +15
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug)
Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)]
Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo
Baseline, Month 12
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Baseline, Month 12
Secondary Endpoints
Percent Change from Baseline in Fasting Serum Triglyceride (TG) Levels
Baseline up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Proportion of Participants Who Achieve Average Fasting TG Levels of < 880 mg/dL (10 mmol/L)
From Month 3 up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Proportion of Participants Who Achieve Fasting TG Levels of < 500 mg/dL (5.65 mmol/L)
From Month 3 up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Plozasiran InjectionEXPERIMENTALPlozasiran by SC injection every 3 months (Q3M) through completion of the randomized period Plozasiran by SC injection Q3M through completion of the OLE period
PlaceboEXPERIMENTALcalculated volume to match active treatment by SC injection (randomized period)
Interventions
NameTypeDescription
PlozasiranDRUGARO-APOC3 injection
PlaceboDRUGsterile normal saline (0.9% NaCl)
Plozasiran InjectionDRUGARO-APOC3 Injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion 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...

Countries:United StatesArgentinaAustriaBrazilBulgariaChinaColombiaHungaryJordanMexicoOmanSaudi ArabiaSerbiaSouth KoreaSwedenUnited Arab EmiratesCanadaCzechiaFranceGermanyLatviaLithuaniaNew ZealandPolandSlovakiaSouth AfricaSpainAustraliaBelgiumCroatiaItalyRomaniaUnited Kingdom
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06880770primaryCompletionDate: changed
LOWMay 26, 2026NCT06347016primaryCompletionDate: changed
LOWMay 26, 2026NCT06347003primaryCompletionDate: changed
LOWMay 24, 2026NCT06880770studyFirstPostDate: changed
LOWMay 24, 2026NCT06347016studyFirstPostDate: changed
LOWMay 24, 2026NCT06347003studyFirstPostDate: changed