Health Trials

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

ConditionSevere Hypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorArrowhead Pharmaceuticals

About this trial

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. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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/m²

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plozasiran

    Drug

    ARO-APOC3 injection

  • Placebo

    Drug

    sterile normal saline (0.9% NaCl)

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: Plozasiran InjectionExperimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug)

Time frame
Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)]

Secondary outcomes

1

Percent Change from Baseline in Fasting Serum Triglyceride (TG) Levels

Time frame
Baseline up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
2

Proportion of Participants Who Achieve Average Fasting TG Levels of < 880 mg/dL (10 mmol/L)

Time frame
From Month 3 up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
3

Proportion of Participants Who Achieve Fasting TG Levels of < 500 mg/dL (5.65 mmol/L)

Time frame
From Month 3 up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
4

Time to First Occurrence of Major Abdominal Pain Event (Event Occurring More Than 10 Days After the First Dose of Study Drug).

Time frame
Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)

Other outcomes

Sponsors and contacts

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Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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