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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study to Evaluate COR-1004 in Adult Volunteers.

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

A Study to Evaluate COR-1004 in Adult Volunteers. (NCT07229118) is a Phase 1 interventional studying Hyperlipidemia, sponsored by Corsera Health. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. The study will look at how different dose levels of COR-1004 affect the levels of LDL cholesterol (often called "bad" cholesterol) in the blood. The study will enroll otherwise healthy volunteers who have LDL cholesterol of 100 mg/dl or higher but are not currently taking any cholesterol-lowering medicines. The main purpose of this study is to test a new drug, COR-1004. Researchers want to find out: * If the drug is safe and if people have any side effects. * The highest dose that can be given without causing serious side effects. * How the body processes the drug. * How the drug affects the amount of "bad" cholesterol in the blood. This is an early-phase study. The information learned will help decide if COR-1004 should be tested in larger studies in the future. To be in this study, you must: * Be generally healthy. * Have an LDL ("bad") cholesterol level of 100 mg/dL or higher. * Not currently be taking any medications to lower your cholesterol. If you decide to join the study, you will be placed into a group by chance, like flipping a coin. This is called "randomization." In each group, most people (8 out of 10) will get a single injection of the study drug (COR-1004). The other people (2 out of 10) will get a placebo. A placebo looks just like the study drug but has no active medicine in it. Using a placebo helps researchers understand the true effects of the real drug. This is a "double-blind" study, which means that neither you nor the study doctor will know if you are getting the study drug or the placebo. The study will test different dose levels of COR-1004. It will start with a low dose and, only if it is proven to be safe, will a new group of participants be given a slightly higher dose. To be extra safe, the first two people in each new dose group will be watched for 24 hours before the other eight people in that group get their injection. After the injection, you will need to visit the study clinic several times over the next year for follow-up. These visits will include: * Answering questions about your health. * Physical exams. * Blood tests to check your safety and your cholesterol levels. A special group of experts, called a Safety Review Committee, will carefully watch over the study to protect all participants. Your active participation in the study, including follow-up visits, will last for about 12 months after you receive the single injection. Because COR-1004 is a new drug, there may be risks that are not yet known. The study staff will explain all the known risks to you before you agree to participate. Known risks may include discomfort at the injection site, like redness, swelling, or pain. The study team will monitor you very closely for any side effects throughout the study.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Hyperlipidemia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hyperlipidemia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form and to comply with the study restrictions. Who Should NOT Join This Trial: - 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DRUG

COR-1004

COR-1004 administered by subcutaneous (SC) injection

DRUG

Placebo

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Clinical Trial Site
Christchurch, New Zealand

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07229118), the sponsor (Corsera Health), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07229118 clinical trial studying?

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. The study will look at how different dose levels of COR-1004 affect the levels of LDL cholesterol (often called "bad" cholesterol) in the blood. The study will enroll otherwise healthy volunteers who have LDL cholesterol of 100 mg/dl or higher but are not currently taking any cholesterol-lowering medicines. The main purpose of this study is to test a new drug, COR-1004. Researchers want to find out: * If the drug is safe and… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07229118?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07229118?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07229118. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07229118. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.