parallel randomized trial

STEP 3

Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy in Subjects With Overweight or Obesity

Overweight or obesity without diabetes (adults)NCT03611582S000988

Design

Randomized: 611
Start year: 2018
Treatment: 68 weeks, follow-up 75 weeks
Countries
Sponsor: Novo Nordisk (industry)
Eligibility: BMI 30 or more, or 27 with comorbidity; no type 2 diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 2.4 mg subcutaneous once weekly Semaglutide 2.4 mg	intensive behavioral therapy; lifestyle: intensive	407	407
A2	Placebo Placebo	intensive behavioral therapy with low calorie diet; lifestyle: intensive	204	204

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	46
age	sd (years)	13	13
asian	n	5	6
black	n	80	36
bmi	mean (kg/m2)	38.1	37.8
female	n	315	180
hispanic	n	75	46
other race american indian	n	1	0
other race pacific islander	n	3	0
other race unknown	n	11	4
white	n	307	158

Analyses this trial contributes to

Results

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

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	change	-6 mmHg	14		372	not stated; full analysis; registry:outcomes
68	A2	change	-2 mmHg	15		188	not stated; full analysis; registry:outcomes

Percent body weight change (6 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1 vs A2	md	-12.67 percent		-14.34 to -11.00		while on treatment; full analysis; registry:outcomes
68	A1	percent change	-16.5 percent	10.1		407	treatment policy; full analysis; registry:outcomes
68	A1 vs A2	md	-10.27 percent		-11.97 to -8.57		treatment policy; full analysis; registry:outcomes
68	A1	percent change	-17.6 percent	9.6		407	while on treatment; full analysis; registry:outcomes
68	A2	percent change	-6.1 percent	7.6		204	while on treatment; full analysis; registry:outcomes
68	A2	percent change	-5.8 percent	7.7		204	treatment policy; full analysis; registry:outcomes

Weight loss of 5 percent or more (6 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
68	A1	responders			323 / 407	treatment policy; full analysis; registry:outcomes
68	A1 vs A2	or	6.11	4.04 to 9.26		treatment policy; full analysis; registry:outcomes
68	A1	responders			300 / 407	while on treatment; full analysis; registry:outcomes
68	A1 vs A2	or	11.67	7.64 to 17.81		while on treatment; full analysis; registry:outcomes
68	A2	responders			90 / 204	treatment policy; full analysis; registry:outcomes
68	A2	responders			82 / 204	while on treatment; full analysis; registry:outcomes

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	responders				281 / 373	not stated; full analysis; registry:outcomes
68	A2	responders				51 / 189	not stated; full analysis; registry:outcomes

Weight loss of 15 percent or more (2 lines; O11C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	responders				208 / 373	not stated; full analysis; registry:outcomes
68	A2	responders				25 / 189	not stated; full analysis; registry:outcomes

Weight loss of 20 percent or more (2 lines; O11D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	responders				133 / 373	not stated; full analysis; registry:outcomes
68	A2	responders				7 / 189	not stated; full analysis; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 407	while on treatment; safety; R0020858:Table 2
	A2	events				0 / 204	while on treatment; safety; R0020858:Table 2

Progression to type 2 diabetes (2 lines; O14)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	treatment policy; full analysis; glycemic_status:prediabetes; R0021798:Results
	A2	events	1.0			1 /	treatment policy; full analysis; glycemic_status:prediabetes; R0021798:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 407	not stated; safety; registry:adverse_events
	A2	events				0 / 204	not stated; safety; registry:adverse_events

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	change	3.2 points	6.0		407	not stated; full analysis; registry:outcomes
68	A2	change	2.6 points	6.5		204	not stated; full analysis; registry:outcomes

Physical functioning (any instrument) (2 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
68	A1	change	2.5 points	5.7		407	not stated; full analysis; registry:outcomes
68	A2	change	1.7 points	5.7		204	not stated; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				37 / 407	not stated; safety; registry:adverse_events
	A2	events				6 / 204	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				26 / 407	not stated; randomized; registry:flow
	A2	events				6 / 204	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				237 / 407	not stated; safety; registry:adverse_events
	A2	events				45 / 204	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				111 / 407	not stated; safety; registry:adverse_events
	A2	events				22 / 204	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				147 / 407	not stated; safety; registry:adverse_events
	A2	events				45 / 204	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				150 / 407	not stated; safety; registry:adverse_events
	A2	events				50 / 204	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (11 lines; O28)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			1 / 407	not stated; safety; biliary dyskinesia; registry:adverse_events
A1	events			7 / 407	not stated; safety; cholelithiasis; registry:adverse_events
A1	events			3 / 407	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events			2 / 407	not stated; safety; cholecystitis; registry:adverse_events
A1 vs A2	rr	3.34	1.00 to 11.11		not stated; safety; R0013578:Table 1
A1	events			20 / 407	not stated; safety; R0013578:Table 1
A2	events			0 / 204	not stated; safety; biliary dyskinesia; registry:adverse_events
A2	events			0 / 204	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events			0 / 204	not stated; safety; cholecystitis; registry:adverse_events
A2	events			0 / 204	not stated; safety; cholelithiasis; registry:adverse_events
A2	events			3 / 204	not stated; safety; R0013578:Table 1

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 407	not stated; safety; papillary thyroid cancer; registry:adverse_events
	A2	events				0 / 204	not stated; safety; papillary thyroid cancer; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 407	not stated; safety; small intestinal obstruction; registry:adverse_events
	A2	events				1 / 204	not stated; safety; small intestinal obstruction; registry:adverse_events