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New shot shows promise for stubborn high fats in blood

NCT ID NCT05355402

Disease control Sponsor: Ionis Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a drug called olezarsen in 154 adults with high triglycerides (a type of blood fat) and either heart disease or very high triglycerides. Participants received injections of the drug or a placebo for up to 12 months. The main goal was to see if the drug could lower triglyceride levels more than placebo.

What this could mean

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

Active substance
olezarsen (a drug injection)
What this could lead to
If it works, this could provide a new treatment option to lower triglycerides and potentially reduce heart disease risk.
What could go wrong
This is a mid-stage trial with only 154 participants, so results may not hold up in larger studies. The drug may cause side effects or fail to improve heart outcomes.

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

154 people

The number who actually took part.

Started

May 2022

Finished

Dec 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.

Inclusion Criteria: 1. Aged ≥ 18 years at the time of informed consent 2. Fall into at least 1 of the following groups (a or b): 1. Hypertriglyceridemia with fasting TG ≥ 150 mg/dL (1.69 millimoles per liter \[mmol/L\]) and \< 500 mg/dL (5.65 mmol/L) with either clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or at increased risk for ASCVD 2. Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L). 3. Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines. 4. Participants must be willing to comply with diet and lifestyle recommendations as able. Exclusion Criteria: 1. Diabetes with any of the following: 1. Newly diagnosed within 12 weeks of screening 2. Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening 3. Change in basal insulin regimen \> 20% within 3 months prior to Screening 4. For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to Screening 2. Acute coronary syndrome or stroke/transient ischemic attack (TIA) within 6 months prior to Screening 3. Major surgery, peripheral revascularization, or non-urgent percutaneous coronary intervention (PCI) within 3 months prior to Screening, or upcoming planned major surgery or major procedure (e.g., arterial revascularization) during the course of the study 4. Active pancreatitis within 4 weeks prior to Screening

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease hypertriglyceridemia

As listed by the trial registrant

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

Atherosclerotic cardiovascular disease Hypertriglyceridemia Severe hypertriglyceridemia

Contacts and locations

Locations

  • Aa Mrc, Llc

    Flint, Michigan, 48504, United States

  • Bluewater Clinical Research Group Inc

    Sarnia, Ontario, N7t 4X3, Canada

  • Catalina Research Institute, LLC

    Montclair, California, 91763, United States

  • Clinical Investigation Specialist

    Gurnee, Illinois, 60031, United States

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121, United States

  • Clinical Trials Research

    Lincoln, California, 95648, United States

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, G1V 4W2, Canada

  • De La Cruz Research Center

    Miami, Florida, 33184, United States

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Evanston Premier Healthcare Research

    Evanston, Illinois, 60201, United States

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434, United States

  • Green and Seidner Family Practice Associates

    Lansdale, Pennsylvania, 19446, United States

  • Health Concepts

    Rapid City, South Dakota, 57702, United States

  • IACT Health

    Columbus, Georgia, 31904, United States

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213, United States

  • Main Street Physicians Care Waterway

    Little River, South Carolina, 29566, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148, United States

  • Research Physicians Network Alliance

    Winter Park, Florida, 32792, United States

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149, United States

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652, United States

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388, United States

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501, United States

  • York Clinical Research LLC

    Norfolk, Virginia, 23504, United States

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