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Type 1 DiabetesPhase 4CHORD1NCT05641753

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

A Phase 4 study testing Evolocumab Cartridge, Atorvastatin Calcium Tablets and Ezetimibe Tablets in people with Type 1 Diabetes, run by NYU Langone Health at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, interventional, cohort study, meaning that researchers will follow and observe a group of enrolled study participants over a period of time (one to two months) to gather information and record any developments of the outcomes in question. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Evolocumab Cartridge, Atorvastatin Calcium Tablets and Ezetimibe Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
4 sitesUnited States
Study dates
6 Dec 2022to 31 Jul 2027
Phase
Phase 4
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 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with previous diagnosis of T1D (as defined by American Diabetes Association or judgment of physician for at least 1 year)
  • American Diabetes Association Criteria for diagnosis of diabetes (Must meet at least 1 of the following criteria):
  • i. FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours, OR;
  • ii. 2-h PG ≥200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water, OR;
  • iii. A1C ≥6.5% (48 mmol/mol), OR;
  • iv. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L), AND;
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  • History of T1D (due to autoimmune β-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood). Autoimmune markers include islet cell autoantibodies and autoantibodies to GAD (glutamic acid decarboxylase, GAD65), insulin, the tyrosine phosphatases islet antigen 2 (IA-2) and IA-2β, and zinc transporter 8, OR;
  • Diagnosis of T1D and confirmed by review of records by 2 separate clinical members of the study team
  • Age ≥ 18 \& < 90
  • LDL-C >100mg/dl
  • Able and willing to provide written informed consent for the study

Who cannot join

  • Established cardiovascular disease on antithrombotic therapy
  • Triglycerides >400mg/dl
  • Use of a PCSK9 inhibitor
  • Recent infection in the past 30 days
  • Any hospitalization in the past 30 days
  • Use of immunosuppressive therapy
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  • Use of any antithrombotic therapy
  • Use of aspirin
  • Use of NSAID within the past 72 hours
  • Pregnancy
  • Anemia (hemoglobin < 9 g/dl) or thrombocytopenia (platelet count <75), or thrombocytosis (platelet count >600)
  • A history of hemorrhagic diathesis
  • Chronic kidney disease (CrCl < 30ml/min)
  • T2D, monogenic diabetes syndromes, or diabetes in the context of disease of the exocrine pancreas (such as pancreatitis, trauma or pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis)

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ira Goldberg, MD contact

646-501-0589

Ira.Goldberg@nyulangone.org

United States4 sites, 4 recruiting

  • New York VA Hospital

    New York, New York, 10010

    Recruiting

  • NYC Health + Hospitals/Bellevue

    New York, New York, 10016

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Mount Sinai School of Medicine

    New York, New York, 10029

    Zahi Fayad

    Recruiting

Other trials in United States

About this study

Official title: CHORD1 - CHOlesterol Lowering and Residual Risk in Diabetes, Type 1

This is a prospective, interventional, cohort study, meaning that researchers will follow and observe a group of enrolled study participants over a period of time (one to two months) to gather information and record any developments of the outcomes in question.

This study will recruit 125 participants with Type 1 Diabetes (T1D) to:

  1. Analyze the effect of reducing the cholesterol levels in the blood on platelet function. (Platelets are small cells in the blood which help form blood clots to slow or stop bleeding and to help wounds heal
  2. Analyze the effect of reducing the cholesterol levels in the blood on While Blood Cell (WBC) gene expression, (White Blood Cells are part of the body's immune system which help the body fight infection and other diseases) and
  3. Analyze the effect of reducing the cholesterol levels in the blood on vascular or blood vessel function.
Read the detailed description

Participants will receive weekly injections of PCSK9i (evolocumab) plus daily, oral pills of atorvastatin or ezetimibe for 1 month.

Participants will undergo blood draw, and optional vascular studies that include:

  • Glycocalyx testing (A non-invasive test where a video microscope camera is placed under the tongue to capture images of the movement of red blood cells as they travel through the micro-blood vessels)
  • PET/CT for vascular imaging - to assess any inflammation of blood vessels and to evaluate increased metabolism in related tissues, and
  • Endothelial cell collection before cholesterol reduction and 1-month after cholesterol reduction to measure any genetic changes in in the endothelial cells before and after collection

Glycemic Variability (GV), the amount one's blood sugar changes throughout the day, will be analyzed from continuous glucose monitoring (CGM) data.

Conditions
Type 1 Diabetes
Being tested
Evolocumab Cartridge, Atorvastatin Calcium Tablets, Ezetimibe Tablets, 18F-FDG, Angiocatheter 20IV
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evolocumab CartridgeDrug

    Also called REPATHA

    Injectable PCSK9 inhibitor.

  • Atorvastatin Calcium TabletsDrug

    Also called LIPITOR

    HMG-CoA reductase inhibitor for oral use.

  • Ezetimibe TabletsDrug

    Also called ZETIA

    Will only be distributed to patients with statin intolerance; replacement for both Atorvastatin and Evolocumab. Inhibitor of intestinal cholesterol for oral use.

  • 18F-FDGDrug

    Optional procedure. Positron emission tomography (PET) and computed tomography (CT) imaging to assess vascular inflammation and related anatomy requires injection of the PET tracer 18F-FDG. 18F-FDG is an FDA-approved analogue of sugar, routinely used to evaluate elevated metabolism in tissues, including increased metabolism due to inflammatory cells. A standard dose of 7.0 mSv will be administered.

  • Angiocatheter 20IVDevice

    Also called BD Insyte Autoguard

    Optional procedure (endothelial cell harvesting). An angiocatheter ≤ 21 gauge will be inserted into a peripheral vein on the upper extremity using aseptic technique. A 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be then advanced into the angiocatheter, to a distance of 4cm beyond the end of the angiocatheter.

  • J-WireDevice

    Optional procedure (endothelial cell harvesting). Either a 0.021in. diameter J-shaped wire (Daig, Minnetonka, MN) or a 0.018in. diameter J-shaped wire (Arrow, Reading, PA) will be used.

  • GlycoCheck Glycocalyx Measurement SoftwareDevice

    Optional procedure (assessment of vascular function). Video microscope developed by GlycoCheck.

Study groups in NCT05641753
Study groupRoleWhat they receive
4-Week LDL-Cholesterol (LDL-C)-Reduction TreatmentExperimentalTreatment consists of: Evolocumab (140 mg; 2 injections, one administered at baseline visit and another self-administered 2 weeks later), and; Atorvastatin (up to 80mg dose; 1 tab per day for 30 days, starting at baseline visit post-assessment). Participants with statin intolerance will be provided with a 1-month supply of ezetimibe 10 mg to replace Evolocumab and Atorvastatin. * Additional procedures: Blood draws. * Optional procedures: Glycocalyx testing, PET/CT, or Endothelial Cell Collection.
Receives: Drug: Evolocumab Cartridge; Drug: Atorvastatin Calcium Tablets; Drug: Ezetimibe Tablets; Drug: 18F-FDG; Device: Angiocatheter 20IV; Device: J-Wire; Device: GlycoCheck Glycocalyx Measurement Software

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Monocyte Platelet Aggregation (MPA) from Baseline

    Measurement of platelet activity. Assessed via patient blood sample.

    Measured: Baseline, Week 4

  2. Change in Light Transmission Aggregation (LTA) from Baseline

    Measurement of platelet activity. Assessed via patient blood sample.

    Measured: Baseline, Week 4

Secondary outcomes (3)

  1. Percent Change in Natural Killer (NK) Cell Population from Baseline

    Assessed via patient blood sample.

    Measured: Baseline, Week 4

  2. Percent Change in Dendritic Cell Population from Baseline

    Assessed via patient blood sample.

    Measured: Baseline, Week 4

  3. Percent Change in CD8 Cell Population from Baseline

    Assessed via patient blood sample.

    Measured: Baseline, Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start6 Dec 2022
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05641753
Sponsor's protocol ID
22-01095
Acronym
CHORD1
Status last verified
Oct 2026
First submitted
29 Nov 2022
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification, will be shared upon reasonable request beginning immediately following publication provided the researchers who provide a methodologically sound proposal for use of the data execute a data use agreement with NYU Langone Health. Requests should be directed to Ira.Goldberg@nyulangone.org. The protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will be made available on Clinicaltrials.gov.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Evolocumab Cartridge, Atorvastatin Calcium Tablets and Ezetimibe Tablets in people with Type 1 Diabetes, run by NYU Langone Health at 4 sites in United States.

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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 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 4 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Ira Goldberg, MD (646-501-0589, Ira.Goldberg@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Monocyte Platelet Aggregation (MPA) from Baseline (time frame: Baseline, Week 4). 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?

On the ClinicalTrials.gov record for NCT05641753.

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 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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