GLP-1 Peptide Atlas, by Delfa

Enrolling by invitationPhase 4

Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)

Evidence Based Evaluation of Incretin Drugs in Reducing the Risk of Cardiovascular and Cerebrovascular Events and Promoting the Remission of Diabetes

Lead sponsor

China-Japan Friendship Hospital

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

142

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 24-32.5•HbA1c 7-10%

Primary endpoints

•Cardiovascular and cerebrovascular event risk score•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)•Expanded / custom MACE composite (Stroke (any))

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06959784

Org study ID2024-1-4064

Timeline

Milestones

Study start2024-01-01actual

Study first posted2025-05-07actual

Last update posted2025-05-07actual

Primary completion2026-12-31estimated

Study completion2026-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Newly diagnosed diabetes, with no previous use of hypoglycemic medications or having discontinued such medications for more than 3 months.

•Blood glucose elevation detected within one year (fasting blood glucose exceeding 7 mmol/L, postprandial blood glucose or random blood glucose exceeding 11.1 mmol/L).

•Age between 30 and 70 years (inclusive of boundary values).

•Hemoglobin A1c between 7% and 10% (inclusive of boundary values).

•BMI between 24 and 32.5 kg/m² (inclusive of boundary values).

Exclusion criteria

•History of coronary heart disease or cerebral infarction.

•Severe liver or kidney disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); glomerular filtration rate less than 30 ml/min/1.73 m².

•History of malignant tumors.

•Use of systemic glucocorticoids (excluding local applications or inhalants) for one week or more within the three months prior to screening.

•Positive urine pregnancy test in women of childbearing age.

•History of pancreatitis, or amylase and/or lipase > 3 times the ULN.

•Personal history or family history of medullary thyroid carcinoma (MTC) in first-degree relatives, or genetic predisposition to MTC (such as multiple endocrine neoplasia syndrome).

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Other (unclassified)

Cardiovascular outcomes

Renal / kidney

Cardiovascular outcomes

2 endpoints

Primary/protocol endpoint

Major Adverse Cardiovascular Events

Time frame:Baseline and every 12 weeks until 96 weeks

3-point MACE

composite event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Primary/protocol endpoint

Cerebrovascular disease events

Time frame:Baseline and every 12 weeks until 96 weeks

Expanded / custom MACE composite

composite event, event

componentsStroke (any)

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

The remission rate of diabetes

Time frame:at 9 months, 1 year and 2 years of follow-up

categorical status, improvement

Secondary/protocol endpoint

Glycated hemoglobin

Time frame:Baseline and every 12 weeks until 96 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting and postprandial blood glucose levels

Time frame:at 2 year and 8 year of follow-up

descriptive, improvement

Secondary/protocol endpoint/low confidence

pancreatic islet function

Time frame:Baseline, 48 weeks and 96 weeks

descriptive

Renal / kidney

2 endpoints

Secondary/protocol endpoint/low confidence

Routine urine examination

Time frame:Baseline, 48 weeks and 96 weeks

descriptive

componentsurine red blood cells, urine white blood cells, urine glucose, urine ketones, urine protein

Secondary/protocol endpoint

Urine microalbumin

Time frame:Baseline, 48 weeks and 96 weeks

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints

Primary/protocol endpoint/low confidence

Cardiovascular and cerebrovascular event risk score

Time frame:One-year follow-up

descriptive

Secondary/protocol endpoint

Heart rate

Time frame:Baseline, 48 weeks and 96 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Carotid resistance index

Time frame:Baseline, 48 weeks and 96 weeks

change from baseline, improvement

Secondary/protocol endpoint

Carotid artery wall thickness

Time frame:Baseline, 48 weeks and 96 weeks

change from baseline, improvement

Secondary/protocol endpoint

Carotid Intima-media Thickness

Time frame:Baseline, 48 weeks and 96 weeks

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Carotid artery peak systolic velocity

Time frame:Baseline, 48 weeks and 96 weeks

descriptive

Secondary/protocol endpoint/low confidence

Heart rhythm

Time frame:Baseline, 48 weeks and 96 weeks

descriptive

Secondary/protocol endpoint/low confidence

Carotid artery peak diastolic velocity

Time frame:Baseline, 48 weeks and 96 weeks

descriptive

Secondary/protocol endpoint/low confidence

common carotid artery diameter

Time frame:Baseline, 48 weeks and 96 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.