Trial Outcomes & Findings for Semaglutide Use in Elderly Obese Patients (NCT NCT05302596)
NCT ID: NCT05302596
Last Updated: 2025-04-17
Results Overview
total fat mass/total fat-free mass ratio reported as arbitrary units (ratio), calculated by dividing total fat mass by total fat-free mass (lean mass) at baseline and at 16 weeks in both groups. Primary measurements of fat and fat-free mass is done using DEXA
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Semaglutide
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Semaglutide
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Semaglutide Use in Elderly Obese Patients
Baseline characteristics by cohort
| Measure |
Semaglutide
n=7 Participants
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
n=7 Participants
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
69.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Body mass index (BMI)
|
38.2 Kg/m^2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
37.0 Kg/m^2
STANDARD_DEVIATION 4.3 • n=7 Participants
|
37.8 Kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Weight
|
107.8 Kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
100.0 Kg
STANDARD_DEVIATION 17.8 • n=7 Participants
|
103.9 Kg
STANDARD_DEVIATION 19.5 • n=5 Participants
|
|
Total Fat Mass
|
52.1 Kg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
47.8 Kg
STANDARD_DEVIATION 9.3 • n=7 Participants
|
50.0 Kg
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Total Fat-Free Mass
|
51.0 Kg
STANDARD_DEVIATION 11.4 • n=5 Participants
|
47.8 Kg
STANDARD_DEVIATION 6.4 • n=7 Participants
|
49.4 Kg
STANDARD_DEVIATION 8.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weekstotal fat mass/total fat-free mass ratio reported as arbitrary units (ratio), calculated by dividing total fat mass by total fat-free mass (lean mass) at baseline and at 16 weeks in both groups. Primary measurements of fat and fat-free mass is done using DEXA
Outcome measures
| Measure |
Semaglutide
n=7 Participants
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
n=7 Participants
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio
Baseline
|
1.04 Arbitrary units (ratio)
Standard Error 0.07
|
1.0 Arbitrary units (ratio)
Standard Error 0.07
|
|
Body Composition as Total Fat Mass/ Total Fat-free Mass Ratio
16 Weeks
|
0.96 Arbitrary units (ratio)
Standard Error 0.06
|
0.99 Arbitrary units (ratio)
Standard Error 0.07
|
PRIMARY outcome
Timeframe: 16 weeksbody weight reported in Kg at at baseline and at 16 weeks in both groups
Outcome measures
| Measure |
Semaglutide
n=7 Participants
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
n=7 Participants
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Body Weight
Baseline
|
107.8 Kg
Standard Error 7.7
|
100.0 Kg
Standard Error 6.7
|
|
Body Weight
16 weeks
|
99.7 Kg
Standard Error 7.2
|
97.1 Kg
Standard Error 7.5
|
SECONDARY outcome
Timeframe: 16 weekstotal fat mass reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups
Outcome measures
| Measure |
Semaglutide
n=7 Participants
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
n=7 Participants
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Total Fat Mass
Baseline
|
52.1 Kg
Standard Error 3.6
|
47.8 Kg
Standard Error 3.9
|
|
Total Fat Mass
16 weeks
|
46.8 Kg
Standard Error 3.6
|
46.3 Kg
Standard Error 4.1
|
SECONDARY outcome
Timeframe: 16 weekstotal fat-free mass (lean mass) reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups
Outcome measures
| Measure |
Semaglutide
n=7 Participants
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
n=7 Participants
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Total Fat-free Mass (Lean Mass)
baseline
|
51.0 Kg
Standard Error 4.2
|
47.8 Kg
Standard Error 2.2
|
|
Total Fat-free Mass (Lean Mass)
16 weeks
|
49.5 Kg
Standard Error 4.0
|
47.0 Kg
Standard Error 2.4
|
Adverse Events
Semaglutide
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard of Care Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Semaglutide
n=7 participants at risk
Semaglutide, added to standard of care, starting dose of 0.25mg titrated up to 1mg dose. for a total of 16 weeks.
Semaglutide Pen Injector: semaglutide (up to 1mg) once weekly injection added to the standard of care weight loss program. Semaglutide dose will be started at 0.25 mg dose during the baseline visit and doubled every 2 weeks up to 1mg dose or up to maximum tolerable dose for total of 16 weeks of intervention
|
Standard of Care Only
n=7 participants at risk
Standard of Care (SOC) weight loss intervention alone (personalized lifestyle and exercise)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal side effects: constipation
|
57.1%
4/7 • Number of events 4 • 16 weeks
|
14.3%
1/7 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
GI side effects: Nausea
|
28.6%
2/7 • Number of events 2 • 16 weeks
|
14.3%
1/7 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
GI side effects: Vomiting
|
14.3%
1/7 • Number of events 1 • 16 weeks
|
0.00%
0/7 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place