Trial Outcomes & Findings for Semaglutide Use in Elderly Obese Patients (NCT 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

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

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

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=99 Participants	69.7 years STANDARD_DEVIATION 5.1 • n=107 Participants	69.8 years STANDARD_DEVIATION 4.9 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	7 participants n=99 Participants	7 participants n=107 Participants	14 participants n=206 Participants
Body mass index (BMI)	38.2 Kg/m^2 STANDARD_DEVIATION 4.7 • n=99 Participants	37.0 Kg/m^2 STANDARD_DEVIATION 4.3 • n=107 Participants	37.8 Kg/m^2 STANDARD_DEVIATION 4.4 • n=206 Participants
Weight	107.8 Kg STANDARD_DEVIATION 19.8 • n=99 Participants	100.0 Kg STANDARD_DEVIATION 17.8 • n=107 Participants	103.9 Kg STANDARD_DEVIATION 19.5 • n=206 Participants
Total Fat Mass	52.1 Kg STANDARD_DEVIATION 8.9 • n=99 Participants	47.8 Kg STANDARD_DEVIATION 9.3 • n=107 Participants	50.0 Kg STANDARD_DEVIATION 9.0 • n=206 Participants
Total Fat-Free Mass	51.0 Kg STANDARD_DEVIATION 11.4 • n=99 Participants	47.8 Kg STANDARD_DEVIATION 6.4 • n=107 Participants	49.4 Kg STANDARD_DEVIATION 8.7 • n=206 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

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 weeks

body weight reported in Kg at at baseline and at 16 weeks in both groups

Outcome measures

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 weeks

total fat mass reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups

Outcome measures

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 16 weeks	46.8 Kg Standard Error 3.6	46.3 Kg Standard Error 4.1
Total Fat Mass Baseline	52.1 Kg Standard Error 3.6	47.8 Kg Standard Error 3.9

SECONDARY outcome

Timeframe: 16 weeks

total fat-free mass (lean mass) reported in Kg and measured using DEXA at baseline and at 16 weeks in both groups

Outcome measures

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

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

Husam Ghanim

State University of NY at Buffalo

Phone: 7168818924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place