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New shot could tame stubborn high cholesterol

NCT ID NCT07223658

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 19, 2026 · Updated 7 times

Summary

This study tests an experimental drug called ARO-DIMERPA in 78 adults with mixed hyperlipidemia (high cholesterol and triglycerides). The drug is given as a shot under the skin, and researchers are checking if it is safe and how well it lowers fats in the blood. The trial is still in early phases, so the main goal is safety, not yet proving it works.

What this could mean

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

Active substance
ARO-DIMERPA (an experimental RNA-targeted drug given as a shot under the skin)
What this could lead to
If it works, this could lead to a new treatment option for people with high cholesterol and triglycerides that is easier to take than daily pills.
What could go wrong
This is an early-phase trial with only 78 people, so it is too soon to know if the drug is safe or effective. Side effects are possible, and the drug may not lower cholesterol enough to matter.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

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: * Willing to follow diet counseling as per Investigator judgment based on local standard of care * Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening * Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later Exclusion Criteria: * Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA * Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy * Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab) * Uncontrolled hypertension * History of bleeding diathesis or coagulopathy * Current diagnosis of nephrotic syndrome Note: Additional inclusion/exclusion criteria may apply per protocol.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia Hyperlipoproteinemia Type II

As listed by the trial registrant

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

Hyperlipidemia; mixed

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site 1

    RECRUITING

    Christchurch, 8011, New Zealand

  • Research Site 10

    RECRUITING

    Calgary, T2N 4N1, Canada

  • Research Site 11

    RECRUITING

    Clayton, 3168, Australia

  • Research Site 12

    RECRUITING

    Wellington, 6021, New Zealand

  • Research Site 13

    RECRUITING

    Tbilisi, 102, Georgia

  • Research Site 14

    RECRUITING

    Tbilisi, 144, Georgia

  • Research Site 15

    RECRUITING

    Tbilisi, 191, Georgia

  • Research Site 16

    RECRUITING

    Toronto, M1S 3V6, Canada

  • Research Site 17

    RECRUITING

    Chicoutimi, G7H 7K9, Canada

  • Research Site 2

    RECRUITING

    Auckland, 622, New Zealand

  • Research Site 3

    RECRUITING

    Auckland, 2025, New Zealand

  • Research Site 4

    RECRUITING

    Melbourne, Victoria, 3153, Australia

  • Research Site 5

    RECRUITING

    Morayfield, Queensland, 4506, Australia

  • Research Site 6

    RECRUITING

    Grafton, Auckland, 1023, New Zealand

  • Research Site 7

    RECRUITING

    Charlestown, New South Wales, 2290, Australia

  • Research Site 8

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Research Site 9

    RECRUITING

    Perth, Western Australia, 6009, Australia