Trial Outcomes & Findings for Impact of Semaglutide on CD34+ EPC and Fat Derived MSC (NCT NCT04126603)
NCT ID: NCT04126603
Last Updated: 2025-09-09
Results Overview
Number of CD34+ EPCs per total MNC ratio. Please note CD34+ cells is a progenitor cell marker derived from mononuclear cells (MNCs).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
First Visit at Baseline and Last Visit at 24 weeks
Results posted on
2025-09-09
Participant Flow
10 patients were enrolled at GWU
Only 10 patients from GWU were enrolled in the study.
Participant milestones
| Measure |
Group A Placebo
Placebos: Placebo injection
|
Group B Active
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Semaglutide on CD34+ EPC and Fat Derived MSC
Baseline characteristics by cohort
| Measure |
Group A Placebo
n=5 Participants
Metformin + Placebo.
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Metformin + Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Age, Continuous
|
59 years
n=39 Participants
|
59 years
n=41 Participants
|
59 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=39 Participants
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=39 Participants
|
5 participants
n=41 Participants
|
10 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksNumber of CD34+ EPCs per total MNC ratio. Please note CD34+ cells is a progenitor cell marker derived from mononuclear cells (MNCs).
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio
First visit
|
0.10 ratio
Standard Deviation 0.06
|
0.23 ratio
Standard Deviation 0.16
|
|
CD34+ Endothelial Progenitor Cell Number (EPC) Per Mononuclear Cells (MNC) Ratio
Last visit
|
0.12 ratio
Standard Deviation 0.03
|
0.13 ratio
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksThe distance the CD34+ EPC migrates in response to SDF1 alpha 10ng. This assess the mobility of stem cells such as CD34+ EPC and the distance it traveled would lead us to understand how medication therapy changes stem cell behavior and its functionality.
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient
First visit
|
708.5 micrometer (um)
Standard Deviation 357.09
|
377.75 micrometer (um)
Standard Deviation 440.17
|
|
CD34+ Endothelial Progenitor Cell Migration (EPC) Against Serum SDF1a Gradient
Last visit
|
530.75 micrometer (um)
Standard Deviation 405.53
|
3232.33 micrometer (um)
Standard Deviation 2553.21
|
PRIMARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weekswe will evaluate mRNA gene expression of endothelial Progenitor cell with catalase, KDR, NOS3,SOD2, TNF-alpha which is normalized to 18s. Fold change of particular genes in hematopoietic stem cells between baseline and terminal visit at week 24 were analyzed.
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Gene Expression of CD34+ Endothelial Progenitor Cell Number
Catalase
|
-0.64 Fold change
Standard Deviation 0.72
|
0.5 Fold change
Standard Deviation 1.52
|
|
Gene Expression of CD34+ Endothelial Progenitor Cell Number
KDR
|
0.78 Fold change
Standard Deviation 0.05
|
1.49 Fold change
Standard Deviation 0.43
|
|
Gene Expression of CD34+ Endothelial Progenitor Cell Number
NOS3
|
-1.88 Fold change
Standard Deviation 0.05
|
2.33 Fold change
Standard Deviation 0.05
|
|
Gene Expression of CD34+ Endothelial Progenitor Cell Number
SOD2
|
0.56 Fold change
Standard Deviation 0.48
|
0.97 Fold change
Standard Deviation 0.69
|
|
Gene Expression of CD34+ Endothelial Progenitor Cell Number
TNF-A
|
3.37 Fold change
Standard Deviation 2.75
|
-1.09 Fold change
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksCFU count of CD34+ EPCs
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
CD34+ Endothelial Cell Colony Formation Unit (CFU)
First Visit
|
12.0 CFUs/mL
Standard Deviation 4.77
|
5.10 CFUs/mL
Standard Deviation 1.56
|
|
CD34+ Endothelial Cell Colony Formation Unit (CFU)
Last Visit
|
12.25 CFUs/mL
Standard Deviation 11.67
|
23.75 CFUs/mL
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksPopulation: Due to freezer power failure in the lab, the fat samples were degraded and could not saved for cryo preservation. As a result, qpcr and histology could not carried out due to lack of samples in frozen state.
We will evaluate mRNA gene expression for mature fat and fat related transcription factors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksVessel health is assessed by looking at Arterial stiffness. Augmentation index (AI) is defined as the ratio of the augmentation pressure to the pulse pressure, times 100, to give a percentage. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor. The higher the values the higher the cardiovascular risk.
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Arterial Stiffness: Pulse Wave Analysis Augmentation Index
First visit
|
23.80 percent
Standard Deviation 11.82
|
29.67 percent
Standard Deviation 4.16
|
|
Arterial Stiffness: Pulse Wave Analysis Augmentation Index
Last visit
|
24.00 percent
Standard Deviation 0.05
|
32.00 percent
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksArterial Stiffness: Pulse Wave Analysis Augmentation Pressure. The higher the values the higher the cardiovascular risk.
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure
First visit
|
10.80 Millimeters of mercury
Standard Deviation 7.69
|
15.33 Millimeters of mercury
Standard Deviation 2.89
|
|
Arterial Stiffness: Pulse Wave Analysis Augmentation Pressure
Last visit
|
8.00 Millimeters of mercury
Standard Deviation 0.05
|
16.50 Millimeters of mercury
Standard Deviation 13.44
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksVessel health is assessed by looking at Arterial stiffness. Augmentation index (AI) is defined as the ratio of the augmentation pressure to the pulse pressure, times 100, to give a percentage. Augmentation index 75 normalizes this value to an estimate of the AI at a heart rate of 75bpm. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor. The higher the values the higher the cardiovascular risk.
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75
First visit
|
23.20 percent
Standard Deviation 15.80
|
32.00 percent
Standard Deviation 7.55
|
|
Arterial Stiffness: Pulse Wave Analysis Augmentation Index 75
Last visit
|
27.00 percent
Standard Deviation 0.05
|
36.50 percent
Standard Deviation 14.85
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksBody mass index measured using Bio metric Impedance Scale
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Body Composition: BMI
First visit
|
34.95 Kilogram per meter squared
Standard Deviation 4.68
|
44.33 Kilogram per meter squared
Standard Deviation 7.75
|
|
Body Composition: BMI
Last visit
|
36.00 Kilogram per meter squared
Standard Deviation 6.32
|
40.77 Kilogram per meter squared
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksPercent of Body Fat measured using Bio metric Impedance Tanita Scale
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Body Composition: Body Fat Percent
First visit
|
41.10 percent
Standard Deviation 5.98
|
50.70 percent
Standard Deviation 0.5
|
|
Body Composition: Body Fat Percent
Last visit
|
39.47 percent
Standard Deviation 9.09
|
49.87 percent
Standard Deviation 6.77
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksHbA1c percent
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Biochemistry: Hemoglobin A1C (HbA1c)
First visit
|
7.67 percent
Standard Deviation 2.05
|
7.80 percent
Standard Deviation 1.27
|
|
Biochemistry: Hemoglobin A1C (HbA1c)
Last visit
|
6.55 percent
Standard Deviation 1.48
|
7.10 percent
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksRatio of Hip to Waist
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Hip to Waist Ratio
First visit
|
0.96 Ratio
Standard Deviation 0.2
|
0.94 Ratio
Standard Deviation 0.06
|
|
Hip to Waist Ratio
Last visit
|
0.79 Ratio
Standard Deviation 0.1
|
0.95 Ratio
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: First Visit at Baseline and Last Visit at 24 weeksratio of LDL over HDL cholesterol
Outcome measures
| Measure |
Group A Placebo
n=5 Participants
Placebos: Placebo injection
|
Group B Active
n=5 Participants
Semaglutide: 0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
|
|---|---|---|
|
Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio
First visit
|
2.43 Ratio
Standard Deviation 0.49
|
1.23 Ratio
Standard Deviation 0.55
|
|
Biochemistry: Low-density Lipoprotein (LPL) Cholesterol Over High-density Lipoprotein (HDL) Ratio
Last visit
|
1.98 Ratio
Standard Deviation 0.28
|
1.97 Ratio
Standard Deviation 0.74
|
Adverse Events
Group A Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place