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New drug plozasiran aims to lower high fats in the blood

NCT ID NCT04998201

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2b trial tested plozasiran, an experimental drug, in 353 adults with mixed dyslipidemia (high triglycerides and cholesterol). Participants received either plozasiran or a placebo, and researchers measured changes in blood fat levels over 48 weeks. The goal is to see if the drug can safely lower these fats when added to standard diet and statin therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Plozasiran (ARO-APOC3 injection)
What this could lead to
If successful, plozasiran could offer a new option to help control high triglycerides and cholesterol in people with mixed dyslipidemia.
What could go wrong
This is a mid-stage trial with results not yet published. The drug may not prove effective or safe enough for approval, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

353 people

The number who actually took part.

Started

Sep 2021

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Based on medical history, prior evidence of triglycerides (TG) ≥ 150 milligrams (mg)/deciliter (dL) and ≤ 499 mg/dL * Fasting levels at Screening of non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL or low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL after at least 2 weeks of stable diet and 4 weeks on stable optimal statin therapy * Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart * Willing to follow diet counseling as per Investigator judgment based on local standard of care * Participants of childbearing potential (males \& females) must use highly effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm and females must not donate eggs during the study and for at least 24 weeks following the last dose of study medication. * Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding * Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1 * Willing to provide written informed consent and to comply with study requirements Key Exclusion Criteria: * Current use or use within 365 days from Day 1 of any hepatocyte targeted short interfering RNA oligonucleotides (siRNA) or antisense oligonucleotide molecule * Active pancreatitis within 12 weeks prior to Day 1 * Any planned bariatric surgery or similar procedures to induce weight loss from consent through end of study * Acute coronary syndrome event within 24 weeks of Day 1 * History of major surgery within 12 weeks of Day 1 or planned major surgery during the study * Planned coronary intervention (such as, stent placement or heart bypass) during the study * New York Heart Association (NYHA) Class II, III or IV heart failure or last known ejection fraction of \<30% * Uncontrolled hypertension * Known history of human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B virus (HBV), seropositive for Hepatitis C virus (HCV) * Uncontrolled hypothyroidism or hyperthyroidism * Hemorrhagic stroke within 24 weeks of Day 1 * History of bleeding diathesis or coagulopathy * Current diagnosis of nephrotic syndrome * Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study * Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply) Note: Additional inclusion/exclusion criteria may apply per protocol

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Conditions

The condition(s) this trial relates to.

hyperlipidemia, familial combined, LPL related

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mixed dyslipidemia

Contacts and locations

Locations

  • Research Site 1

    Fort Lauderdale, Florida, 33308, United States

  • Research Site 10

    Montreal, Quebec, H2W2T2, Canada

  • Research Site 11

    Auckland, 2025, New Zealand

  • Research Site 12

    Dayton, Ohio, 45419, United States

  • Research Site 13

    San Antonio, Texas, 78249, United States

  • Research Site 14

    Miami Springs, Florida, 33166, United States

  • Research Site 15

    Concord, Ontario, L4K 4M2, Canada

  • Research Site 16

    Christchurch, 8013, New Zealand

  • Research Site 17

    New Windsor, New York, 12553, United States

  • Research Site 18

    Dunwoody, Georgia, 30338, United States

  • Research Site 19

    Clayton, Victoria, 3168, Australia

  • Research Site 2

    Boca Raton, Florida, 33434, United States

  • Research Site 20

    Balatonfüred, H-8230, Hungary

  • Research Site 21

    Debrecen, H-4032, Hungary

  • Research Site 22

    Nyíregyháza, H-4405, Hungary

  • Research Site 24

    Lodz, 94-048, Poland

  • Research Site 25

    Poznan, 61-655, Poland

  • Research Site 26

    Rzeszów, 35-055, Poland

  • Research Site 27

    Joondalup, Western Australia, 6027, Australia

  • Research Site 28

    Lodz, 93-338, Poland

  • Research Site 29

    Adelaide, South Australia, 5000, Australia

  • Research Site 3

    Beverly Hills, California, 90211, United States

  • Research Site 30

    Morayfield, Queensland, 4506, Australia

  • Research Site 31

    Las Vegas, Nevada, 89121, United States

  • Research Site 32

    Houston, Texas, 77030, United States

  • Research Site 4

    Franklin, Ohio, 45005, United States

  • Research Site 5

    Pembroke Pines, Florida, 33024, United States

  • Research Site 6

    Houston, Texas, 77002, United States

  • Research Site 7

    Greenville, South Carolina, 29607, United States

  • Research Site 8

    Northridge, California, 91325, United States

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