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New shot aims to tame dangerous fat levels in blood

NCT ID NCT06471543

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a single dose of a new drug called RN0361 in 108 adults. It includes healthy volunteers and people with very high triglycerides, a type of fat in the blood that can cause serious health problems. The goal is to see if the drug is safe and lowers fat levels. This is an early-stage trial, so the main focus is safety and how the body processes the drug.

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 108 people

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

Started

Sep 2024

Expected to finish

Aug 2026

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 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Phase I: Inclusion Criteria: * Willing to provide written informed consent before any study-specific procedures. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol. * Fasting serum triglyceride levels \> 80 mg/dL and fasting LDL-C ≥70 mg/dL at screening * Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. * Participants must avoid sperm or egg donation during the study Exclusion Criteria: * History or presence of any serious or uncontrolled disease * clinically significant health concerns * Recent vaccination with live vaccines, except for influenza, or plans to receive such during the study. * Positive tests for alcohol or drugs of abuse at screening. * History of multiple drug allergies or allergic reactions to specific components used in the study. Phase II: Inclusion Criteria: * Willing to provide written informed consent before any study-specific procedures. * Comply with the study requirements and restrictions as listed in the Informed Consent Form and the protocol. * Fasting serum triglyceride levels ≥ 300 mg/dL at screening * Female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. Male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. Exclusion Criteria: * History or presence of any serious or uncontrolled disease * Active pancreatitis within 12 weeks prior to Day 1 * Uncontrolled hypertension (sitting blood pressure) \>160/100 mm Hg * Uncontrolled diabetes * Symptomatic heart failure (NYHA II-IV) * Positive serologic test of HBV, HCV, or HIV * Alcohol or drugs abuse * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc. * History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc) * History of malignancy within the last 2 years prior to the date of consent Note: Additional inclusion/exclusion ceiteria may apply, per protocol.

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Conditions

The condition(s) this trial relates to.

familial chylomicronemia syndrome Familial hyperchylomicronemia syndrome hypertriglyceridemia

As listed by the trial registrant

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

Contacts and locations

Locations

  • Altona Clinical Research

    Altona N., Victoria, 3025, Australia

  • Axis Clinicals USA

    Dilworth, Minnesota, 56529, United States

  • Nucleus Network Melbourne

    Melbourne, Victoria, 3004, Australia

  • Ogden Clinic, Mountain View / Avacare

    Pleasant View, Utah, 84404, United States

  • Synergy Groups Medical

    Houston, Texas, 77061, United States

  • TBC Research LLC,

    Tamarac, Florida, 33321, United States

  • Tranquil

    Webster, Texas, 77598, United States

  • University of the Sunshine Coast Clinical Trials

    Morayfield, Queensland, Australia

  • University of the Sunshine Coast Clinical Trials, Sippy Downs

    Sippy Downs, Queensland, 4556, Australia

  • Versailles Family Medicine / Avacare

    Versailles, Kentucky, 40383, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.