Home › Trials › NCT07229118
Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 18 to 65

COR-1004 for adults with high LDL cholesterol

Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered COR-1004

Run by Corsera Health · NCT07229118 · Data updated 2026-11-12

This trial will test a single injectable dose of COR-1004 to see if it's safe and how it changes LDL cholesterol in otherwise healthy adults with LDL ≥100 mg/dL who are not taking cholesterol medicines.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment80 (estimated)
SponsorCorsera Health
Industry-sponsored
Locations2 sites (Christchurch and 1 other locations)
StatusRecruiting
StartedNovember 28, 2025
Main results expectedFebruary 2027
Study endsNovember 2027
Registry record updatedOctober 26, 2026
Trial IDNCT07229118 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Otherwise healthy adults with LDL-C ≥100 mg/dL who are not taking any cholesterol-lowering medications and who meet the study's safety and contraception requirements are ideal candidates.

Probably not a fit

People with active or chronic medical conditions, significant psychiatric illness, high ASCVD risk (≥7.5%), or those already on lipid-lowering therapy are excluded and unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-ascending-dose study that gives one subcutaneous dose of COR-1004 to sequential cohorts of adults with LDL-C ≥100 mg/dL. Each cohort enrolls 10 participants randomized 4:1 to active drug or placebo, with sentinel dosing for the first five cohorts to monitor early safety. Participants return for outpatient visits for safety, tolerability, pharmacokinetics, pharmacodynamics, and exploratory biomarker sampling through Day 90, with additional safety follow-up through Month 12. Results will inform the tolerated dose range, how the body processes the drug, and whether COR-1004 lowers LDL sufficiently to justify larger trials.

Why it matters

Potential benefit: If successful, COR-1004 could become an additional injectable option to lower LDL cholesterol for people not currently on lipid-lowering therapy.

How similar studies have gone: Other injectable lipid-lowering agents such as PCSK9 inhibitors have successfully lowered LDL, but COR-1004 is a novel investigational agent and this is an early first-in-human dosing study.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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 must be willing to use two highly effective methods of contraception, one of which must be a barrier method (e.g., condom) through the end of the study (Day 360). Male participants and their same-sex partners must use a barrier method of contraception. Male participants must be willing not to donate sperm until the end of the study. Male participants who had vasectomy must provide the date of the procedure.
* 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 estimated glomerular filtration rate (eGFR) \<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).

Where it's running

  • Clinical Trial Site 1
    Christchurch, New Zealand     Recruiting
  • Clinical Trial Site 2
    Wellington, New Zealand     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Hyperlipidemia 32
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.