COR-1004 for adults with high LDL cholesterol

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

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

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Corsera Health (Industry-sponsored)
• Locations: 1 site (Christchurch)
• Trial ID: NCT07229118 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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, 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).

Where this trial is running

Christchurch

• Clinical Trial Site — Christchurch, New Zealand (Recruiting)

Study contacts

• Study coordinator: Corsera Clinical Trial Information Line

Conditions Hyperlipidemia; lipid-lowering therapy