Study of RN0361in Adult Healthy Subjects and Adult Hypertriglyceridemic Subjects
NCT ID: NCT06471543
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
108 participants
INTERVENTIONAL
2024-09-30
2026-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RN0361
subcutaneous injections
RN0361
Placebo
Placebo
calculated volume to match active treatment
RN0361
Placebo
Interventions
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RN0361
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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:
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Ikaria Bioscience Pty Ltd
INDUSTRY
Responsible Party
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Locations
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TBC Research LLC,
Tamarac, Florida, United States
Versailles Family Medicine / Avacare
Versailles, Kentucky, United States
Axis Clinicals USA
Dilworth, Minnesota, United States
Synergy Groups Medical
Houston, Texas, United States
Tranquil
Webster, Texas, United States
Ogden Clinic, Mountain View / Avacare
Pleasant View, Utah, United States
University of the Sunshine Coast Clinical Trials
Morayfield, Queensland, Australia
University of the Sunshine Coast Clinical Trials, Sippy Downs
Sippy Downs, Queensland, Australia
Altona Clinical Research
Altona N., Victoria, Australia
Nucleus Network Melbourne
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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RN0361-101
Identifier Type: -
Identifier Source: org_study_id