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New shot aims to lower bad cholesterol in early trial
NCT ID NCT07229118
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This early-phase study tests a new injectable drug, COR-1004, for safety and proper dosing in people with high LDL (bad) cholesterol. About 60 healthy volunteers who are not on cholesterol meds will receive a single shot of the drug or a placebo. Researchers will monitor side effects and cholesterol levels for a year to guide future studies.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2027
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 65 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.
Inclusion 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 after study drug administration. * Able to participate, and willing to give written informed consent and to comply with the study restrictions. Exclusion Criteria: * 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 \<40 bpm or \>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) above the upper bound of the normal reference range (as per the local laboratory reference range) at Screening. * 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 exception of acetaminophen/paracetamol up to 2 g per day up to 48 hours prior to dosing or medications for contraception. Other exceptions will only be made if the rationale is discussed and clearly documented between the Clinical Research Organization and Sponsor. * Received any medication, herbal supplements, or nutraceutical known to alter serum lipids within 30 days before Screening (eg, niacin).
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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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Clinical Trial Site
Christchurch, 6011, New Zealand
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Other studies related to the condition(s) this trial covers.
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