New shot aims to tame dangerous fat levels in blood
NCT ID NCT06471543
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Altona Clinical Research
Altona N., Victoria, 3025, Australia
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Axis Clinicals USA
Dilworth, Minnesota, 56529, United States
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Nucleus Network Melbourne
Melbourne, Victoria, 3004, Australia
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Ogden Clinic, Mountain View / Avacare
Pleasant View, Utah, 84404, United States
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Synergy Groups Medical
Houston, Texas, 77061, United States
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TBC Research LLC,
Tamarac, Florida, 33321, United States
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Tranquil
Webster, Texas, 77598, United States
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University of the Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
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University of the Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, 4556, Australia
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Versailles Family Medicine / Avacare
Versailles, Kentucky, 40383, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Omega-3 metabolite put to the test for Post-Meal blood fats
- Can a new siRNA injection keep high triglycerides in check for the long haul?
- Can a Plant-Based protein switch reshape your metabolism?
- Fish oil pills put to the test: can they tame high triglycerides?
- Can a new shot tame a rare fat disorder in kids?
- Weekly shot aims to tame dangerous fat levels in the blood