Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dLPhase 1NCT07858019
A Study to Evaluate COR-2003 as Monotherapy and Co-Administered With COR-1004 in Adult Volunteers
A Phase 1 study testing COR-2003 and COR-1004 + COR-2003 in people with Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL, run by Corsera Health at 2 sites in 2 countries.
Trial summary
This clinical trial has two parts. In Part A, the goal is to learn about the safety and tolerability of COR-2003 when it is given alone. In Part B, the goal is to learn about the safety and tolerability of COR-2003 and COR-1004 when given together. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
- What is being tested?
- COR-2003 and COR-1004 + COR-2003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2026to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening visit SBP from 110 to 139 mmHg and DBP <90 mmHg based on the average of three consecutive measurements in a single visit via AOBPM
- Body mass index between 18.5 and 35 kg/m2, inclusive
- Untreated serum LDL-C ≥100 mg/dL (≥2.6 mmol/L).
- Absence of evidence or diagnoses of acute or chronic disease following a detailed medical and surgical history
- Female participants who are of childbearing potential must be willing to use two highly effective methods of contraception
- Able to participate, and willing to give written informed consent and to comply with the study restrictions[S
Who cannot join
- Any active or chronic disease
- Confirmed SBP ≥140 mmHg or DBP ≥90 mmHg at Screening
- History of orthostatic hypotension, postural orthostatic tachycardic syndrome, unexplained dizziness, fatigue, pre-syncope, or syncope.
- Resting pulse rate <50 or >100 beats/min.
- Age ≥ 40 years and having a 10-year risk of ASCVD ≥ 7.5% based on the ASCVD Risk Estimator Plus (PREVENT™ mode) from the American College of Cardiology
- 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 that, in the opinion of the investigator, increases the risk of participating in the study will be excluded. Screening, Day 1, or pre-dose QTcF < 300 msec or > 450 msec for males and > 470 msec for females.
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- Clinically significant abnormalities on physical examination, vital signs, or laboratory test results during Screening or prior to admission to the study unit.
- Fasting triglyceride level ≥ 400 mg/dL (≥ 4.52 mmol/L).
- Estimated glomerular filtration rate (eGFR) < 60 mL/min.
- Alanine aminotransferase (ALT) and/or total bilirubin > 1.5 × Upper Limits of Normal (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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
About this study
Official title: A Two-part, Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered COR-2003, as Monotherapy (Part A) and Co-administered With COR-1004 (Part B)
This clinical trial has two parts. In Part A, the goal is to learn about the safety and tolerability of COR-2003 when it is given alone. In Part B, the goal is to learn about the safety and tolerability of COR-2003 and COR-1004 when given together.
The main questions it aims to answer in Part A are:
Read more
- How well is COR-2003 absorbed in the blood?
- Do any medical problems develop in participants taking COR-2003?
- How well do participants tolerate COR-2003 compared to a placebo (a look-alike injection that contains no drug)?
The main questions it aims to answer in Part B are:
- How well are COR-1004 + COR-2003 absorbed in the blood when dosed at the same time?
- Do any medical problems develop in participants taking COR-1004 + COR-2003?
- How well do participants tolerate COR-1004 + COR-2003 compared to placebo + placebo (two look-alike injections that contains no drug)?
Participants will:
- Receive one or two subcutaneous injection(s) of COR-2003 or placebo (Part A) or receive two subcutaneous injections - one injection of COR-2003 and one injection of COR-1004 or two placebo injections (Part B).
- Visit the clinic for checkups and tests before the trial starts, complete a 3-night in-patient stay, followed by 14 follow up visits (monthly) until the trial ends (approximately 13 months).
- Being tested
- COR-2003, Placebo, COR-1004 + COR-2003, Placebo + Placebo
- Keywords
- lipid-lowering therapy,, hyperlipidemia, blood pressure management, cardiovascular prevention
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR-2003Drug
A single dose of COR-2003 will be administered subcutaneously
PlaceboDrug
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study
COR-1004 + COR-2003Drug
A single dose of COR-1004 and a single dose of COR-2003 will be co-administered subcutaneously
Placebo + PlaceboDrug
Sterile 0.9% (w/v) saline will be used as placebo treatment during the study
| Study group | Role | What they receive |
|---|---|---|
| COR-2003 monotherapy | Experimental | Not described Receives: Drug: COR-2003 |
| COR-1004 + COR-2003 | Experimental | Not described Receives: Drug: COR-1004 + COR-2003 |
| Placebo monotherapy | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo + Placebo | Placebo comparator | Not described Receives: Drug: Placebo + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study
Part A: The number, frequency and severity of clinical and laboratory treatment-related adverse events during 360 days in participants receiving a single dose of COR-2003, as assessed by CTCAE v6.
Measured: Baseline, 12 months
Part B: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study
Part B: The number, frequency and severity of clinical and laboratory treatment-related adverse events during 360 days in participants receiving a single dose of COR-1004 + COR-2003, as assessed by CTCAE v6.
Measured: Baseline, 12 months
Secondary outcomes (18)
To characterize the maximum observed concentration (Cmax)
Measured: Predose through Day 8
To characterize the maximum observed concentration (Tmax)
Measured: Predose through Day 8
To characterize the area under the concentration versus time curve (AUC)
Measured: Predose through Day 8
To characterize the elimination half-life (t1/2).
Measured: Predose through Day 8
Part A: Change from baseline in systolic blood pressure as measured by AOBPM
Change from baseline in systolic blood pressure as measured by automated office blood pressure monitoring (AOBPM) up to 360 days, in participants receiving a single dose of COR-2003.
Measured: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part A: Change from baseline in diastolic blood pressure as measured by AOBPM
Change from baseline in diastolic blood pressure as measured by automated office blood pressure monitoring (AOBPM) up to 360 days, in participants receiving a single dose of COR-2003.
Measured: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part A: Change from baseline in systolic blood pressure as measured by ABPM
Change from baseline in systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) up to 180 days, in participants receiving a single dose of COR-2003.
Measured: Baseline (pre-dose), Day 30 and Day 180
Part A: Change from baseline in diastolic blood pressure as measured by ABPM
Change from baseline in diastolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) up to 180 days, in participants receiving a single dose of COR-2003.
Measured: Baseline (pre-dose), Day 30 and Day 180
Part B: Measure the maximum plasma concentration (Cmax) of COR-1004 and COR-2003 when co-administered
The plasma maximum concentration (Cmax) of COR-1004 and COR-2003 and their potential metabolites will be evaluated, after a single subcutaneous co-administration.
Measured: Predose and through Day 8
Part B: Change from baseline in AGT
Change from baseline in the plasma concentration of angiotensinogen (AGT) as measured by enzyme-linked immunosorbent assay (ELISA) up to 360 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose) and through Day 360
Part B: Change from baseline in LDL-C
Change from baseline in the blood levels of low-density lipoprotein cholesterol (LDL-C) up to 360 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose) and through Day 360
Part B: Change from baseline in PCSK9
Change from baseline in the plasma concentration of proprotein convertase subtilisin/kexin type 9 (PCSK9) as measured by enzyme-linked immunosorbent assay (ELISA) up to 360 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose) and through Day 360
Part B: Change from baseline in SBP as measured by AOBPM
Change from baseline in systolic blood pressure as measured by automated office blood pressure monitoring (AOBPM) up to 360 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part B: Change from baseline in DBP as measured by AOBPM
Change from baseline in diastolic blood pressure as measured by automated office blood pressure monitoring (AOBPM) up to 360 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part B: Change from baseline in SBP as measured by ABPM
Change from baseline in systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) up to 180 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose), Day 30 and Day 180
Part B: Change from baseline in DBP as measured by ABPM
Change from baseline in diastolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) up to 180 days, in participants receiving a single dose of COR-1004 + COR-2003.
Measured: Baseline (pre-dose), Day 30 and Day 180
Part B: Measure the plasma elimination half-life (t1/2) of COR-1004 and COR-2003 when co-administered
The plasma elimination half-life (t1/2) of COR-1004 and COR-2003 and their potential metabolites will be evaluated, after a single subcutaneous co-administration.
Measured: Predose and through Day 8
Part B: Measure the area plasma concentration - time curve (AUC) of COR-1004 and COR-2003 when co-administered
The area under plasma concentration - time curve (AUC) of COR-1004 and COR-2003 and their potential metabolites will be evaluated, after a single subcutaneous co-administration.
Measured: Predose and through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsera Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858019
- Sponsor's protocol ID
- COR-PAG-26-101
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered COR-2003, as Monotherapy (Part A) and Co-administered With COR-1004 (Part B)
- ClinicalTrials.gov ID
- NCT07858019
- Acronym / sponsor ID
- COR-PAG-26-101
- Keywords
- lipid-lowering therapy,, hyperlipidemia, blood pressure management, cardiovascular prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Corsera HealthIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial has two parts. In Part A, the goal is to learn about the safety and tolerability of COR-2003 when it is given alone. In Part B, the goal is to learn about the safety and tolerability of COR-2003 and COR-1004 when given together.
The main questions it aims to answer in Part A are:
- How well is COR-2003 absorbed in the blood?
- Do any medical problems develop in participants taking COR-2003?
- How well do participants tolerate COR-2003 compared to a placebo (a look-alike injection that contains no drug)?
The main questions it aims to answer in Part B are:
- How well are COR-1004 + COR-2003 absorbed in the blood when dosed at the same time?
- Do any medical problems develop in participants taking COR-1004 + COR-2003?
- How well do participants tolerate COR-1004 + COR-2003 compared to placebo + placebo (two look-alike injections that contains no drug)?
Participants will:
- Receive one or two subcutaneous injection(s) of COR-2003 or placebo (Part A) or receive two subcutaneous injections - one injection of COR-2003 and one injection of COR-1004 or two placebo injections (Part B).
- Visit the clinic for checkups and tests before the trial starts, complete a 3-night in-patient stay, followed by 14 follow up visits (monthly) until the trial ends (approximately 13 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COR-2003 monotherapy | Experimental | Drug: COR-2003 |
| COR-1004 + COR-2003 | Experimental | Drug: COR-1004 + COR-2003 |
| Placebo monotherapy | Placebo comparator | Drug: Placebo |
| Placebo + Placebo | Placebo comparator | Drug: Placebo + Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Screening visit SBP from 110 to 139 mmHg and DBP <90 mmHg based on the average of three consecutive measurements in a single visit via AOBPM
- Body mass index between 18.5 and 35 kg/m2, inclusive
- Untreated serum LDL-C ≥100 mg/dL (≥2.6 mmol/L).
- Absence of evidence or diagnoses of acute or chronic disease following a detailed medical and surgical history
- Female participants who are of childbearing potential must be willing to use two highly effective methods of contraception
Key exclusion criteria (10 listed)
- Any active or chronic disease
- Confirmed SBP ≥140 mmHg or DBP ≥90 mmHg at Screening
- History of orthostatic hypotension, postural orthostatic tachycardic syndrome, unexplained dizziness, fatigue, pre-syncope, or syncope.
- Resting pulse rate <50 or >100 beats/min.
- Age ≥ 40 years and having a 10-year risk of ASCVD ≥ 7.5% based on the ASCVD Risk Estimator Plus (PREVENT™ mode) from the American College of Cardiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COR-2003A single dose of COR-2003 will be administered subcutaneously | Drug | COR-2003 monotherapy |
| PlaceboSterile 0.9% (w/v) saline will be used as placebo treatment during the study | Drug | Placebo monotherapy |
| COR-1004 + COR-2003A single dose of COR-1004 and a single dose of COR-2003 will be co-administered subcutaneously | Drug | COR-1004 + COR-2003 |
| Placebo + PlaceboSterile 0.9% (w/v) saline will be used as placebo treatment during the study | Drug | Placebo + Placebo |
Primary outcome
Part A: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study
Time frame: Baseline, 12 months
Part A: The number, frequency and severity of clinical and laboratory treatment-related adverse events during 360 days in participants receiving a single dose of COR-2003, as assessed by CTCAE v6.
Part B: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study
Time frame: Baseline, 12 months
Part B: The number, frequency and severity of clinical and laboratory treatment-related adverse events during 360 days in participants receiving a single dose of COR-1004 + COR-2003, as assessed by CTCAE v6.
18 secondary outcomes
To characterize the maximum observed concentration (Cmax)
Time frame: Predose through Day 8
To characterize the maximum observed concentration (Tmax)
Time frame: Predose through Day 8
To characterize the area under the concentration versus time curve (AUC)
Time frame: Predose through Day 8
To characterize the elimination half-life (t1/2).
Time frame: Predose through Day 8
Part A: Change from baseline in systolic blood pressure as measured by AOBPM
Time frame: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part A: Change from baseline in diastolic blood pressure as measured by AOBPM
Time frame: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part A: Change from baseline in systolic blood pressure as measured by ABPM
Time frame: Baseline (pre-dose), Day 30 and Day 180
Part A: Change from baseline in diastolic blood pressure as measured by ABPM
Time frame: Baseline (pre-dose), Day 30 and Day 180
Part B: Measure the maximum plasma concentration (Cmax) of COR-1004 and COR-2003 when co-administered
Time frame: Predose and through Day 8
Part B: Change from baseline in AGT
Time frame: Baseline (pre-dose) and through Day 360
Part B: Change from baseline in LDL-C
Time frame: Baseline (pre-dose) and through Day 360
Part B: Change from baseline in PCSK9
Time frame: Baseline (pre-dose) and through Day 360
Part B: Change from baseline in SBP as measured by AOBPM
Time frame: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part B: Change from baseline in DBP as measured by AOBPM
Time frame: Baseline (pre-dose), Day 1, Day 3, Day 8 Day 15, Day 30, and monthly through Day 360
Part B: Change from baseline in SBP as measured by ABPM
Time frame: Baseline (pre-dose), Day 30 and Day 180
Part B: Change from baseline in DBP as measured by ABPM
Time frame: Baseline (pre-dose), Day 30 and Day 180
Part B: Measure the plasma elimination half-life (t1/2) of COR-1004 and COR-2003 when co-administered
Time frame: Predose and through Day 8
Part B: Measure the area plasma concentration - time curve (AUC) of COR-1004 and COR-2003 when co-administered
Time frame: Predose and through Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COR-2003 and COR-1004 + COR-2003 in people with Otherwise Healthy Individuals With Systolic Blood Pressure (SBP) From 110 to 139 mmHg and Low-density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL, run by Corsera Health at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corsera Clinical Trial Information Line (781-203-5206, clinicaltrials@corsera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number and severity of adverse events and number of participants with adverse events to day 90 and until completion of the study (time frame: Baseline, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.