parallel randomized trial

STABLE Wt Loss

Short- and Long-term Effects of Once Weekly Semaglutide 2.4 mg on Appetite, Eating Behavior, and Psychosocial Status

Overweight or obesity without diabetes (adults)Weight maintenance after a GLP-1 receptor agonist containing run in NCT05548647S001294

Design

Randomized: 120
Start year: 2022
Treatment: 60 weeks, follow-up 60 weeks
Countries: United States (1 sites)
Sponsor: University of Pennsylvania (industry)
Eligibility: age 18 to 70; BMI 30 or more, or 27 or more with comorbidity; no diabetes; HbA1c 6.5 percent or less

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: jump to reference multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	lifestyle: standard	72	72
A2	Placebo Placebo	lifestyle: standard	48	48
A3	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide continued weeks 60 to 72	lifestyle: not reported	10	10
A4	Placebo Semaglutide switched to placebo weeks 60 to 72	lifestyle: not reported	43	43

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 2.4 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	46.7	44.2
age	sd (years)	11.5	12.7
asian	n	2	3
asian	percent	2.8	6.3
black	n	18	8
black	percent	25.0	16.7
bmi	mean (kg/m2)	37.8	37.0
bmi	sd (kg/m2)	6.2	5.3
female	n	55	39
female	percent	76.4	81.3
hispanic	n	7	5
hispanic	percent	9.7	10.4
other ethnicity middle eastern arab	n	3	1
other ethnicity middle eastern arab	percent	4.2	2.1
other race other	n	1	2
other race other	percent	1.4	4.2
weight	mean (kg)	106.9	106.2
weight	sd (kg)	21.4	19.4
white	n	51	35
white	percent	70.8	72.9

Analyses this trial contributes to

Results

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

Percent body weight change (27 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	percent change	-9.7 percent	0.6	-10.9 to -8.5		not stated; randomized; R0013679:Table 3
20	A1	percent change	-9.8 percent	0.6	-11.0 to -8.6	70	not stated; completers; R0013679:Supplement Table S4
20	A1	percent change	-9.8 percent	0.6	-11.0 to -8.6		not stated; randomized; R0013679:Supplement Table S3
20	A2	percent change	-4.7 percent	0.9	-6.4 to -2.9		not stated; randomized; R0013679:Table 3
20	A2	percent change	-4.7 percent	0.8	-6.3 to -3.1	37	not stated; completers; R0013679:Supplement Table S4
20	A2	percent change	-4.7 percent	0.9	-6.5 to -3.0		not stated; randomized; R0013679:Supplement Table S3
20	A2 vs A1	md	5.0 percent	1.1	2.9 to 7.1		not stated; randomized; R0013679:Table 3
20	A2 vs A1	md	5.1 percent	1.0	3.1 to 7.1		not stated; completers; R0013679:Supplement Table S4
20	A2 vs A1	md	5.1 percent	1.1	2.9 to 7.2		not stated; randomized; R0013679:Supplement Table S3
40	A1	percent change	-14.6 percent	0.9	-16.4 to -12.7		not stated; randomized; R0013679:Table 3
40	A1	percent change	-15.8 percent	0.8	-17.4 to -14.2	62	not stated; completers; R0013679:Supplement Table S4
40	A1	percent change	-15.1 percent	0.9	-16.9 to -13.4		not stated; randomized; R0013679:Supplement Table S3
40	A2	percent change	-5.5 percent	1.3	-8.2 to -2.8		not stated; randomized; R0013679:Table 3
40	A2	percent change	-7.5 percent	1.2	-9.9 to -5.1	27	not stated; completers; R0013679:Supplement Table S4
40	A2	percent change	-5.6 percent	1.3	-8.2 to -3.1		not stated; randomized; R0013679:Supplement Table S3
40	A2 vs A1	md	9.0 percent	1.6	5.8 to 12.2		not stated; randomized; R0013679:Table 3
40	A2 vs A1	md	8.3 percent	1.4	5.5 to 11.2		not stated; completers; R0013679:Supplement Table S4
40	A2 vs A1	md	9.5 percent	1.6	6.4 to 12.6		not stated; randomized; R0013679:Supplement Table S3
60	A1	percent change	-15.1 percent	1.3	-17.6 to -12.6		not stated; randomized; R0013679:Table 3
60	A1	percent change	-18.5 percent	1.1	-20.7 to -16.3	58	not stated; completers; R0013679:Supplement Table S4
60	A1	percent change	-17.2 percent	1.1	-19.4 to -15.0		not stated; randomized; R0013679:Supplement Table S3
60	A2	percent change	-3.4 percent	1.8	-6.8 to 0.1		not stated; randomized; R0013679:Table 3
60	A2	percent change	-5.8 percent	1.6	-9.0 to -2.5	26	not stated; completers; R0013679:Supplement Table S4
60	A2	percent change	-3.4 percent	1.7	-6.7 to -0.1		not stated; randomized; R0013679:Supplement Table S3
60	A2 vs A1	md	11.7 percent	2.1	7.6 to 15.9		not stated; randomized; R0013679:Table 3
60	A2 vs A1	md	12.7 percent	2.0	8.8 to 16.6		not stated; completers; R0013679:Supplement Table S4
60	A2 vs A1	md	13.8 percent	2.0	9.8 to 17.7		not stated; randomized; R0013679:Supplement Table S3

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 72	not stated; randomized; R0013679:Table 4
A2	events	0 / 48	not stated; randomized; R0013679:Table 4
A3	events	0 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Events / N	Detail
A2	events	0 / 48	not stated; randomized; R0013679:Table 4
A3	events	0 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	3 / 72	not stated; randomized; R0013679:Table 4
A2	events	0 / 48	not stated; randomized; R0013679:Table 4
A3	events	0 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	53 / 72	not stated; randomized; R0013679:Table 4
A2	events	12 / 48	not stated; randomized; R0013679:Table 4
A3	events	0 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	25 / 72	not stated; randomized; R0013679:Table 4
A2	events	3 / 48	not stated; randomized; R0013679:Table 4
A3	events	1 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	2 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	27 / 72	not stated; randomized; R0013679:Table 4
A2	events	11 / 48	not stated; randomized; R0013679:Table 4
A3	events	2 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	38 / 72	not stated; randomized; R0013679:Table 4
A2	events	8 / 48	not stated; randomized; R0013679:Table 4
A3	events	1 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	1 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 72	not stated; randomized; cholelithiasis; R0013679:Table 4
A2	events	0 / 48	not stated; randomized; cholelithiasis; R0013679:Table 4
A3	events	0 / 10	while on treatment; safety; period:second_randomization; cholelithiasis; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; cholelithiasis; registry:adverse_events

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 72	not stated; randomized; R0013679:Table 4
A2	events	0 / 48	not stated; randomized; R0013679:Table 4
A3	events	0 / 10	while on treatment; safety; period:second_randomization; registry:adverse_events
A4	events	0 / 43	while on treatment; safety; period:second_randomization; registry:adverse_events