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New RNA drug shows promise for cholesterol control

NCT ID NCT04832971

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2b trial tested an experimental drug called ARO-ANG3 in 204 adults with mixed dyslipidemia, a condition with high triglycerides and cholesterol. Participants received injections of the drug or a placebo over several months. The goal was to see if the drug safely lowers fat levels in the blood, potentially offering a new way to manage heart disease risk.

What this could mean

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

Active substance
ARO-ANG3 (an experimental RNA-targeted drug given as an injection)
What this could lead to
If successful, this could lead to a new treatment option for people with mixed dyslipidemia to better control their cholesterol and triglyceride levels.
What could go wrong
This is a mid-stage trial with only 204 participants, so results may not apply to everyone. The drug is still experimental, and its long-term safety and effectiveness are not yet proven.

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

204 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2024

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.

Inclusion Criteria: * Based on medical history, evidence of triglycerides (TG) ≥ 150 mg/dL but ≤ 499 mg/dL * Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and 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 and maintain a stable diet per Investigator judgment based on local standard of care * Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication * Women of childbearing potential must have a negative pregnancy test 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 * Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication * Able and willing to provide written informed consent and to comply with study requirements Exclusion Criteria: * Current use or use within 365 days from Day 1 of any hepatocyte targeted 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 to end of study * Acute coronary syndrome event within 24 weeks of Day 1 * Major surgery within 12 weeks of Day 1 or planned surgery during the study * Planned coronary intervention (e.g., stent placement or heart bypass) during the study * Uncontrolled hypertension * Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (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

    Marion, Ohio, 43302, United States

  • Research Site 10

    Omaha, Nebraska, 68114, United States

  • Research Site 11

    Houston, Texas, 77030, United States

  • Research Site 12

    Québec, G1G 3Z4, Canada

  • Research Site 13

    Christchurch, 8011, New Zealand

  • Research Site 14

    Rotorua, 3010, New Zealand

  • Research Site 15

    Greensboro, North Carolina, 27408, United States

  • Research Site 16

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Research Site 17

    Miami, Florida, 33144, United States

  • Research Site 18

    Nedlands, 6009, Australia

  • Research Site 19

    Birkenhead, 0626, New Zealand

  • Research Site 2

    Morehead City, North Carolina, 28557, United States

  • Research Site 20

    Hamilton, 3200, New Zealand

  • Research Site 21

    Sippy Downs, Queensland, 4556, Australia

  • Research Site 22

    New York, New York, 10029, United States

  • Research Site 23

    Las Vegas, Nevada, 89121, United States

  • Research Site 24

    Minneapolis, Minnesota, 55455, United States

  • Research Site 25

    London, Ontario, N6A 5A5, Canada

  • Research Site 4

    Camp Hill, Pennsylvania, 17011, United States

  • Research Site 5

    Huntington Park, California, 90255, United States

  • Research Site 6

    Blacktown, New South Wales, 2148, Australia

  • Research Site 7

    Hialeah, Florida, 33012, United States

  • Research Site 8

    Port Orange, Florida, 32127, United States

  • Research Site 9

    Québec, H7T2P5, Canada

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