GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

Impact of Semaglutide (Long Acting GLP1 Agonist) on Peripheral Blood Derived CD34+ Endothelial Cells (EPCs) and Subcutaneous Fat Derived Mesenchymal Stromal Cells ( MSCs) in Type 2 Diabetes Subjects

Lead sponsor

Sabyasachi Sen

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 6.5-12%•eGFR ≥30•UACR ≥30

Primary endpoints

•CD34+ Endothelial Progenitor Cell Number (EPC)•CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient•Gene Expression of CD34+ Endothelial Progenitor Cell Number

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 IDNCT04126603

Org study IDNCR191206

Timeline

Milestones

Study start2019-08-01actual

Study first posted2019-10-15actual

Primary completion2023-10-25actual

Study completion2025-05-14actual

Last update posted2025-09-09actual

Results first posted2025-09-09actual

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 20-90

•Diagnosed with Type 2 diabetes mellitus

•Body Mass Index (BMI) between 25.0-45.0 (both inclusive)

•eGFR ≥ 30 mL/min/1.73 m2 by MDRD

•HbA1C 6.5 - 12.0 %

•Subjects on lifestyle modification alone, or Metformin (0.5-2 grams), insulin, or in combination, in any doses of either Metformin or Insulin for at least 3 months prior to screening. 2 week washout of any other anti-hyperglycemic.

•Ability to provide informed consent (and document informed consent by signature) before any trial-related activities are conducted.

•Additional CVD risk factor such microalbuminuria or proteinuria (as defined by ADA, UACR > 30 mg/g), hypertension (labile, uncontrolled hypertension or controlled on anti-hypertensives) and left ventricular hypertrophy, left ventricular systolic or diastolic dysfunction, or an ankle brachial index [the ratio of the systolic blood pressure at the ankle to the systolic blood pressure in the arm] of less than 0.9, low HDL with hypertriglyceridemia (as defined by NCEP ATP III) , strong family history of CHD (as defined by NCEP ATP III and ATP IV).

•Retinal examination within last 2 years of enrollment, showing no proliferative retinopathy

Exclusion criteria

•Uncontrolled hyperglycemia with fasting glucose >300 mg/dL (>16.6 mmol/L)

•Liver disease with ALT, AST or ALP ≥ x3 ULN

•Known (recent) personal history of cerebral stroke or heart attack (myocardial infarction) within last 6 months

•Personal or family history of medullary thyroid cancer (MTC)

•Personal or family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)

•GFR <30 mL/min/1.73 m2 by MDRD

•Prior surgery with chronic malabsorption (eg, bariatric) within last 1 year

•Clinically significant RBC disorders such as hemoglobinopathies

•Diagnosis of Type 1 diabetes mellitus or history of GAD antibody positive status

•Chronic use of high dose anti-inflammatory drugs for the last 3 months

•Beginning statin medications or change in statin dose within the past 1 month

•Starting use of high-dose steroid medication (100mg hydrocortisone or 40mg prednisone equivalent) within the last 1 month

•History of acute pancreatitis within the past 2 years

•Known or suspected allergy to GLP-1 agonists, excipients, or related products.

•Active smokers, >5 per day (at present)

•Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

•Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration plus 2 months post treatment (for semaglutide washout).

•Women who are pregnant or breastfeeding

•Chronic or persistent alcohol or drug abuse

•Prisoners or subjects who are involuntarily incarcerated

•Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness

•Participation in another trial with an investigational drug within 30 days prior to informed consent.

•Untreated or active hemorrhagic proliferative diabetic retinopathy

Exclusionary Laboratory Findings

•Chronic Kidney Disease (CKD) stage 5 (estimated CrCl less than 15 mL/min)

•Triglycerides > 500 mg/dL

•Low hematocrit (<28 Units)

Endpoints (26)

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

Other (unclassified)

Weight & body composition

Glycemic / diabetes

Weight & body composition

7 endpoints

Secondary/registry result

Body Composition: BMI

Time frame:First Visit at Baseline and Last Visit at 24 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per meter squared	95% CI
Group A PlaceboFirst visit	34.95	—
Last visit	36.00	—
Group B ActiveFirst visit	44.33	—
Last visit	40.77	—

Secondary/registry result

Body Composition: Body Fat Percent

Time frame:First Visit at Baseline and Last Visit at 24 weeks

Total fat mass

change from baseline, improvement

Posted result

Group	Value (mean), percent	95% CI
Group A PlaceboFirst visit	41.10	—
Last visit	39.47	—
Group B ActiveFirst visit	50.70	—
Last visit	49.87	—

Secondary/registry result

Hip to Waist Ratio

Time frame:First Visit at Baseline and Last Visit at 24 weeks

ratio, improvement

Posted result

Group	Value (mean), Ratio	95% CI
Group A PlaceboFirst visit	0.96	—
Last visit	0.79	—
Group B ActiveFirst visit	0.94	—
Last visit	0.95	—

Secondary/protocol endpoint/low confidence

Gene Expression of Subcutaneous Adipose Cell

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Body Composition: BMI

Time frame:First Visit at Baseline and Last Visit at 24 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Body Composition: Body Fat Percent

Time frame:First Visit at Baseline and Last Visit at 24 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Hip to Waist Ratio

Time frame:First Visit at Baseline and Last Visit at 24 weeks

ratio, improvement

Glycemic / diabetes

2 endpoints

Secondary/registry result

Biochemistry: Hemoglobin A1C (HbA1c)

Time frame:First Visit at Baseline and Last Visit at 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent	95% CI
Group A PlaceboFirst visit	7.67	—
Last visit	6.55	—
Group B ActiveFirst visit	7.80	—
Last visit	7.10	—

Secondary/protocol endpoint

Biochemistry: Hemoglobin A1C (HbA1c)

Time frame:First Visit at Baseline and Last Visit at 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

9 endpoints

Primary/protocol endpoint/low confidence

CD34+ Endothelial Cell Colony Formation Unit (CFU)

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Secondary/registry result

Arterial Stiffness: Pulse Wave Analysis Augmentation Index

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), percent	95% CI
Group A PlaceboFirst visit	23.80	—
Last visit	24.00	—
Group B ActiveFirst visit	29.67	—
Last visit	32.00	—

Secondary/registry result

Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), Millimeters of mercury	95% CI
Group A PlaceboFirst visit	10.80	—
Last visit	8.00	—
Group B ActiveFirst visit	15.33	—
Last visit	16.50	—

Secondary/registry result

Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), percent	95% CI
Group A PlaceboFirst visit	23.20	—
Last visit	27.00	—
Group B ActiveFirst visit	32.00	—
Last visit	36.50	—

Secondary/registry result/low confidence

Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio

Time frame:First Visit at Baseline and Last Visit at 24 weeks

ratio, improvement

Posted result

Group	Value (mean), Ratio	95% CI
Group A PlaceboFirst visit	2.43	—
Last visit	1.98	—
Group B ActiveFirst visit	1.23	—
Last visit	1.97	—

Secondary/protocol endpoint

Arterial Stiffness: Pulse Wave Analysis Augmentation Index

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio

Time frame:First Visit at Baseline and Last Visit at 24 weeks

ratio, improvement

Other (unclassified)

8 endpoints

Primary/registry result/low confidence

CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio

Time frame:First Visit at Baseline and Last Visit at 24 weeks

ratio, descriptive

Posted result

Group	Value (mean), ratio	95% CI
Group A PlaceboFirst visit	0.10	—
Last visit	0.12	—
Group B ActiveFirst visit	0.23	—
Last visit	0.13	—

Primary/registry result/low confidence

CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), micrometer (um)	95% CI
Group A PlaceboFirst visit	708.5	—
Last visit	530.75	—
Group B ActiveFirst visit	377.75	—
Last visit	3232.33	—

Primary/registry result/low confidence

Gene Expression of CD34+ Endothelial Progenitor Cell Number

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), Fold change	95% CI
Group A PlaceboCatalase	-0.64	—
KDR	0.78	—
NOS3	-1.88	—
SOD2	0.56	—
TNF-A	3.37	—
Group B ActiveCatalase	0.5	—
KDR	1.49	—
NOS3	2.33	—
SOD2	0.97	—
TNF-A	-1.09	—

Primary/registry result/low confidence

CD34+ Endothelial Cell Colony Formation Unit (CFU)

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), CFUs/mL	95% CI
Group A PlaceboFirst Visit	12.0	—
Last Visit	12.25	—
Group B ActiveFirst Visit	5.10	—
Last Visit	23.75	—

Primary/protocol endpoint/low confidence

CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio

Time frame:First Visit at Baseline and Last Visit at 24 weeks

ratio, descriptive

Primary/protocol endpoint/low confidence

CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient

Time frame:First Visit at Baseline and Last Visit at 24 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Gene Expression of CD34+ Endothelial Progenitor Cell Number

Time frame:First Visit at Baseline and Last Visit at 24 weeks

percent change from baseline, descriptive

Secondary/registry result/low confidence

Gene Expression of Subcutaneous Adipose Cell

Time frame:First Visit at Baseline and Last Visit at 24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.