parallel randomized trial

NCT05786521

The Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Biomarkers of Aging in Older Overweight/Obese Adults With Insulin Resistance

Overweight or obesity without diabetes (adults)NCT05786521S000230

Design

Randomized: 20
Start year: 2023
Treatment: 20 weeks, follow-up 20 weeks
Countries: United States (1 sites)
Sponsor: University of Texas Health Science Center at San Antonio (non industry)
Eligibility: age 65 or older; BMI 27 to 40; HbA1c 5.7 to 7.5 percent or fasting glucose above 100 mg/dL

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide plus lifestyle counseling	lifestyle counseling based on Diabetes Prevention Program; lifestyle: standard	10	10
A2	Standard care or no added treatment Lifestyle counseling alone	lifestyle counseling based on Diabetes Prevention Program; lifestyle: standard	10	10

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Standard care or no added treatment A2	Whole trial ALL
age	mean (years)	73.4	71.9	72.7
age	sd (years)	4.9	5.0	4.8
bmi	mean (kg/m2)	34.1	31.8	32.9
bmi	sd (kg/m2)	3.7	4.1	4.0
female	n	5	5	10
female	percent	50	50	50
hispanic	n	4	5	9
hispanic	percent	40	50	45
other diabetes	n	5	1	6
other diabetes	percent	50	10	30
other prediabetes	n	5	9	14
other prediabetes	percent	50	90	70
weight	mean (kg)	95.7	87.8	91.8
weight	sd (kg)	16.0	16.7	16.4
white	n	9	9	18
white	percent	90	90	90

Analyses this trial contributes to

Results

8 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	change	-4.9 kg		-6.8 to -3.0	10	not stated; randomized; R0003242:Results
20	A2	change	-0.8 kg		-2.7 to 1.0	10	not stated; randomized; R0003242:Results

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	percent change	-5.32 percent			10	not stated; randomized; R0003242:Results
20	A2	percent change	-0.89 percent			10	not stated; randomized; R0003242:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 10	not stated; randomized; registry:adverse_events
	A2	events				0 / 10	not stated; randomized; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 10	not stated; randomized; registry:adverse_events
	A2	events				0 / 10	not stated; randomized; registry:adverse_events