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New treatment option for Hyperlipidemia
Official title A Study to Evaluate COR-1004 in Adult Volunteers.
ClinicalTrials.gov ID: NCT07229118
What this study is testing
What is COR-1004?
COR-1004 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hyperlipidemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research study is being done to see if a new, injectable drug called COR-1004 is safe for people to take. It will also help doctors find the right dose of the drug.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Serum LDL-C ≥100 mg/dL (≥2.6 mmol/L) at Screening.
- Female participants who are of childbearing potential must be willing to use two highly effective methods of contraception, one of which should be a...
- Post-menopausal females must be post-menopausal for 12 months.
- Male participants and their partners of child-bearing potential, or same-sex partners, must be willing to use two highly effective methods of...
- Able to participate, and willing to give written informed consent and to comply with the study restrictions.
You likely can't join if
- Any active or chronic disease.
- Active or history of serious mental illness or psychiatric disorder.
- Clinically significant illness within seven days before study drug administration.
- Having risk of atherosclerotic cardiovascular disease (ASCVD) ≥7.5% based on the ASCVD Risk Estimator Plus.
- Having fasting triglyceride level ≥400 mg/dL (≥4.52 mmol/L).
- Clinically significant abnormalities on physical examination, vital signs, or laboratory test results (except for serum LDL-C) during Screening or...
See the full eligibility criteria
- Serum LDL-C ≥100 mg/dL (≥2.6 mmol/L) at Screening.
- Female participants who are of childbearing potential must be willing to use two highly effective methods of contraception, one of which should be a barrier method.
- Post-menopausal females must be post-menopausal for 12 months.
- Male participants and their partners of child-bearing potential, or same-sex partners, must be willing to use two highly effective methods of contraception, one of which must be a barrier method (eg, condom) for 90 days...
- Able to participate, and willing to give written informed consent and to comply with the study restrictions.
- Any active or chronic disease.
- Active or history of serious mental illness or psychiatric disorder.
- Clinically significant illness within seven days before study drug administration.
- Having risk of atherosclerotic cardiovascular disease (ASCVD) ≥7.5% based on the ASCVD Risk Estimator Plus.
- Having fasting triglyceride level ≥400 mg/dL (≥4.52 mmol/L).
- Clinically significant abnormalities on physical examination, vital signs, or laboratory test results (except for serum LDL-C) during Screening or prior to admission to the study unit.
- Participants with any risk factors or family history for QT or Fridericia-corrected QT interval (QTcF) prolongation or ECG abnormalities or any abnormality in the ECG.
- Confirmed systolic blood pressure (SBP) \>140 mmHg or diastolic blood pressure (DBP) \>90 mmHg at Screening, Day -1, or pre-dose.
- Mean resting pulse rate \ 90 bpm at Screening.
- Abnormal renal function including serum creatinine greater than the upper limit of normal (ULN) or calculated creatinine clearance \<60 mL/min (using the Cockcroft-Gault formula).
- Alanine aminotransferase (ALT) and/or total bilirubin above the ULN. Aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma glutamyl transferase (GGT) \>2 × ULN. International normalized ratio (INR)...
- Positive hepatitis B surface antigen, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection.
- Pregnant or lactating women, or males with female partners who are pregnant or lactating.
- History of multiple drug allergies or history of allergic reaction to an oligonucleotide, N-acetylgalactosamine (GalNAc), or inclisiran.
- Participation in an investigational drug or device study within 45 days or five half-lives (whichever time period is longer) or six months for biologic therapies prior to study drug administration.
- Received small interfering ribonucleic acid (siRNA) as an investigational or approved product prior to study drug administration.
- Use of any medications (prescription or over-the-counter) or herbal supplements within two weeks or five half-lives (whichever is longer) prior to study drug administration (six months for biologic therapies), with...
- Received any medication, herbal supplements, or nutraceutical known to alter serum lipids within 30 days before Screening (eg, niacin).
The study team makes the final eligibility decision.
Where it's taking place
- Christchurch, New Zealand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Christchurch, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.