parallel randomized trial

SURMOUNT-J

Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)

Overweight or obesity without diabetes (adults)NCT04844918S001216

Design

Randomized: 225
Start year: 2021
Treatment: 72 weeks, follow-up 76 weeks
Countries: Japan (17 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 20 or more; BMI 27 to below 35 with 2 or more ORHDs or BMI 35 or more with 1 or more; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: standard	75	75
A2	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg	lifestyle: standard	73	73
A3	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	lifestyle: standard	77	77

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Tirzepatide 10 mg subcutaneous once weekly A2	Tirzepatide 15 mg subcutaneous once weekly A3
age	mean (years)	52.3	49.0	51.1
age	sd (years)	10.9	10.9	10.3
asian	n	75	73	77
black	n	0	0	0
bmi: 35 or more	n	26	24	27
bmi: 35 or more	percent	34.7	32.9	35.1
bmi: less than 35	n	49	49	50
bmi: less than 35	percent	65.3	67.1	64.9
bmi	mean (kg/m2)	33.7	33.2	33.6
bmi	sd (kg/m2)	4.9	4.1	4.3
female	n	30	30	32
female	percent	40.0	41.1	41.6
hba1c	mean (percent)	5.7	5.7	5.7
hba1c	sd (percent)	0.3	0.3	0.4
hispanic	n	0	0	0
other race american indian alaska native	n	0	0	0
other race multiple	n	0	0	0
other race native hawaiian pacific islander	n	0	0	0
sbp	mean (mmHg)	125.0	125.4	125.7
sbp	sd (mmHg)	13.0	12.9	12.0
waist	mean (cm)	108.7	107.7	107.6
waist	sd (cm)	10.9	9.8	10.4
weight	mean (kg)	92.0	92.4	91.7
weight	sd (kg)	15.3	15.0	14.8
white	n	0	0	0

Results

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

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	1.9 mmHg	1.35		66	not stated; modified itt; registry:outcomes
72	A2	change	-11.2 mmHg	1.42		59	not stated; modified itt; registry:outcomes
72	A2 vs A1	md	-13.2 mmHg		-17.0 to -9.3		not stated; modified itt; registry:outcomes
72	A3 vs A1	md	-13.9 mmHg		-17.7 to -10.1		not stated; modified itt; registry:outcomes
72	A3	change	-12.0 mmHg	1.35		65	not stated; modified itt; registry:outcomes

Percent body weight change (56 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	percent change	-1.4 percent			40	hypothetical; modified itt; sex:male; R0014642:Supplement Figure S1
72	A1	percent change	-1.4 percent			58	hypothetical; modified itt; age:less_than_65; R0014642:Supplement Figure S1
72	A1	percent change	-2.0 percent			26	hypothetical; modified itt; sex:female; R0014642:Supplement Figure S1
72	A1	percent change	-3.1 percent			8	hypothetical; modified itt; age:65_or_older; R0014642:Supplement Figure S1
72	A1	percent change	-1.8 percent	1.4		24	hypothetical; modified itt; bmi:27_to_less_than_30; R0014642:Supplement Table S5
72	A1	percent change	-2.2 percent	1.7		17	hypothetical; modified itt; bmi:35_to_less_than_40; R0014642:Supplement Table S5
72	A1	percent change	-0.7 percent	1.8		9	hypothetical; modified itt; bmi:40_or_more; R0014642:Supplement Table S5
72	A1	percent change	-1.7 percent	0.90		66	not stated; modified itt; registry:outcomes
72	A1	percent change	-1.8 percent	4.9		66	hypothetical; modified itt; R0013407:Figure 4
72	A1	percent change	-1.5 percent	1.8		25	hypothetical; modified itt; bmi:30_to_less_than_35; R0014642:Supplement Table S5
72	A2	percent change	-21.6 percent	1.5		20	hypothetical; modified itt; bmi:27_to_less_than_30; R0014642:Supplement Table S5
72	A2 vs A1	md	-19.8 percent				hypothetical; modified itt; bmi:27_to_less_than_30; R0014642:Supplement Table S5
72	A2	percent change	-17.8 percent	0.94		59	not stated; modified itt; registry:outcomes
72	A2	percent change	-18.6 percent	1.7		27	hypothetical; modified itt; bmi:30_to_less_than_35; R0014642:Supplement Table S5
72	A2 vs A1	md	-17.1 percent		-22.1 to -12.2		hypothetical; modified itt; bmi:30_to_less_than_35; R0014642:Supplement Table S5
72	A2 vs A1	md	-16.1 percent		-18.7 to -13.5		not stated; modified itt; registry:outcomes
72	A2	percent change	-13.3 percent			22	hypothetical; modified itt; bmi:35_or_more; R0014642:Supplement Figure S1
72	A2 vs A1	md	-11.7 percent		-15.6 to -7.8		hypothetical; modified itt; bmi:35_or_more; R0014642:Results
72	A2	percent change	-16.5 percent			32	hypothetical; modified itt; sex:male; R0014642:Supplement Figure S1
72	A2 vs A1	md	-11.0 percent		-15.7 to -6.2		hypothetical; modified itt; bmi:35_to_less_than_40; R0014642:Supplement Table S5
72	A2	percent change	-21.1 percent			2	hypothetical; modified itt; age:65_or_older; R0014642:Supplement Figure S1
72	A2 vs A1	md	-18.0 percent		-25.9 to -10.2		hypothetical; modified itt; age:65_or_older; R0014642:Results
72	A2	percent change	-17.4 percent	3.0		4	hypothetical; modified itt; bmi:40_or_more; R0014642:Supplement Table S5
72	A2 vs A1	md	-16.7 percent		-24.0 to -9.3		hypothetical; modified itt; bmi:40_or_more; R0014642:Supplement Table S5
72	A2	percent change	-20.3 percent			37	hypothetical; modified itt; bmi:less_than_35; R0014642:Supplement Figure S1
72	A2 vs A1	md	-18.7 percent		-22.0 to -15.5		hypothetical; modified itt; bmi:less_than_35; R0014642:Results
72	A2	percent change	-19.5 percent			27	hypothetical; modified itt; sex:female; R0014642:Supplement Figure S1
72	A2 vs A1	md	-17.5 percent		-21.6 to -13.4		hypothetical; modified itt; sex:female; R0014642:Results
72	A2	percent change	-17.5 percent			57	hypothetical; modified itt; age:less_than_65; R0014642:Supplement Figure S1
72	A2 vs A1	md	-16.2 percent		-18.9 to -13.5		hypothetical; modified itt; age:less_than_65; R0014642:Results
72	A2	percent change	-13.1 percent	1.6		20	hypothetical; modified itt; bmi:35_to_less_than_40; R0014642:Supplement Table S5
72	A2 vs A1	md	-15.1 percent		-18.2 to -11.9		hypothetical; modified itt; sex:male; R0014642:Results
72	A2	percent change	-18.4 percent	7.6		59	hypothetical; modified itt; R0013407:Figure 4
72	A3	percent change	-23.7 percent	2.2		6	hypothetical; modified itt; bmi:40_or_more; R0014642:Supplement Table S5
72	A3	percent change	-22.6 percent	8.9		65	hypothetical; modified itt; R0013407:Figure 4
72	A3	percent change	-22.7 percent	0.90		65	not stated; modified itt; registry:outcomes
72	A3 vs A1	md	-21.1 percent		-23.6 to -18.5		not stated; modified itt; registry:outcomes
72	A3	percent change	-16.0 percent			6	hypothetical; modified itt; age:65_or_older; R0014642:Supplement Figure S1
72	A3 vs A1	md	-13.0 percent		-19.0 to -6.9		hypothetical; modified itt; age:65_or_older; R0014642:Results
72	A3	percent change	-23.5 percent			59	hypothetical; modified itt; age:less_than_65; R0014642:Supplement Figure S1
72	A3 vs A1	md	-22.1 percent		-24.8 to -19.5		hypothetical; modified itt; age:less_than_65; R0014642:Results
72	A3	percent change	-19.9 percent	1.5		19	hypothetical; modified itt; bmi:27_to_less_than_30; R0014642:Supplement Table S5
72	A3 vs A1	md	-18.1 percent		-22.2 to -14.0		hypothetical; modified itt; bmi:27_to_less_than_30; R0014642:Supplement Table S5
72	A3	percent change	-24.9 percent	1.6		30	hypothetical; modified itt; bmi:30_to_less_than_35; R0014642:Supplement Table S5
72	A3 vs A1	md	-23.3 percent		-28.2 to -18.5		hypothetical; modified itt; bmi:30_to_less_than_35; R0014642:Supplement Table S5
72	A3	percent change	-21.9 percent			28	hypothetical; modified itt; bmi:35_or_more; R0014642:Supplement Figure S1
72	A3 vs A1	md	-20.4 percent		-24.0 to -16.7		hypothetical; modified itt; bmi:35_or_more; R0014642:Results
72	A3	percent change	-22.5 percent	1.6		21	hypothetical; modified itt; bmi:35_to_less_than_40; R0014642:Supplement Table S5
72	A3 vs A1	md	-20.3 percent		-25.0 to -15.6		hypothetical; modified itt; bmi:35_to_less_than_40; R0014642:Supplement Table S5
72	A3 vs A1	md	-23.0 percent		-29.1 to -16.9		hypothetical; modified itt; bmi:40_or_more; R0014642:Supplement Table S5
72	A3	percent change	-23.4 percent			37	hypothetical; modified itt; bmi:less_than_35; R0014642:Supplement Figure S1
72	A3 vs A1	md	-21.7 percent		-25.0 to -18.5		hypothetical; modified itt; bmi:less_than_35; R0014642:Results
72	A3	percent change	-26.8 percent			27	hypothetical; modified itt; sex:female; R0014642:Supplement Figure S1
72	A3 vs A1	md	-24.9 percent		-29.0 to -20.8		hypothetical; modified itt; sex:female; R0014642:Results
72	A3	percent change	-19.6 percent			38	hypothetical; modified itt; sex:male; R0014642:Supplement Figure S1
72	A3 vs A1	md	-18.1 percent		-21.2 to -15.1		hypothetical; modified itt; sex:male; R0014642:Results

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	20		75	not stated; modified itt; registry:outcomes
72	A2	responders	94.37		71	not stated; modified itt; registry:outcomes
72	A2 vs A1	or	119.65	29.06 to 492.67		not stated; modified itt; registry:outcomes
72	A3	responders	96.05		76	not stated; modified itt; registry:outcomes
72	A3 vs A1	or	153.57	36.03 to 654.53		not stated; modified itt; registry:outcomes

Weight loss of 10 percent or more (5 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	4		75	not stated; modified itt; registry:outcomes
72	A2	responders	85.92		71	not stated; modified itt; registry:outcomes
72	A2 vs A1	or	185.92	46.39 to 745.16		not stated; modified itt; registry:outcomes
72	A3	responders	92.11		76	not stated; modified itt; registry:outcomes
72	A3 vs A1	or	318.02	74.49 to 1357.79		not stated; modified itt; registry:outcomes

Weight loss of 15 percent or more (5 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	1.33		75	not stated; modified itt; registry:outcomes
72	A2 vs A1	or	100.21	18.64 to 538.74		not stated; modified itt; registry:outcomes
72	A2	responders	63.38		71	not stated; modified itt; registry:outcomes
72	A3 vs A1	or	286.73	50.68 to 1622.06		not stated; modified itt; registry:outcomes
72	A3	responders	82.89		76	not stated; modified itt; registry:outcomes

Acute kidney injury (3 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	not stated; safety; registry:adverse_events
A2	events	0 / 73	not stated; safety; registry:adverse_events
A3	events	1 / 77	not stated; safety; registry:adverse_events

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	not stated; safety; registry:adverse_events
A2	events	0 / 73	not stated; safety; registry:adverse_events
A3	events	0 / 77	not stated; safety; registry:adverse_events

SF-36 physical component summary change (5 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	final	52.8 points	5.6		69	hypothetical; modified itt; R0013407:Figure 2
72	A2	final	53.6 points	5.9		63	hypothetical; modified itt; R0013407:Figure 2
72	A2 vs A1	md	0.6 points		-0.9 to 2.1		hypothetical; modified itt; R0013407:Figure 2
72	A3	final	54.8 points	5.0		68	hypothetical; modified itt; R0013407:Figure 2
72	A3 vs A1	md	1.7 points		0.2 to 3.2		hypothetical; modified itt; R0013407:Figure 2

Physical functioning (any instrument) (19 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	2.2 points	2.0		69	hypothetical; modified itt; R0013407:Results
72	A1	change	3.6 points	16.6		66	hypothetical; modified itt; R0013407:Figure 4
72	A1	change	-0.1 points	0.4		69	hypothetical; modified itt; R0013407:Results
72	A1	final	68.3 points	23.9		69	hypothetical; modified itt; R0013407:Figure 1
72	A1	final	53.3 points	4.8		69	hypothetical; modified itt; R0013407:Figure 2
72	A2	change	15.2 points	2.1		63	hypothetical; modified itt; R0013407:Results
72	A2	change	15.1 points	18.2		59	hypothetical; modified itt; R0013407:Figure 4
72	A2	change	1.1 points	0.4		63	hypothetical; modified itt; R0013407:Results
72	A2	final	81.3 points	17.9		63	hypothetical; modified itt; R0013407:Figure 1
72	A2	final	54.9 points	4.4		63	hypothetical; modified itt; R0013407:Figure 2
72	A2 vs A1	md	13.0 points		7.4 to 18.7		hypothetical; modified itt; R0013407:Results
72	A2 vs A1	md	1.3 points		0.2 to 2.3		hypothetical; modified itt; R0013407:Results
72	A3	change	13.0 points	2.0		69	hypothetical; modified itt; R0013407:Results
72	A3	change	13.8 points	19.1		65	hypothetical; modified itt; R0013407:Figure 4
72	A3	change	2.0 points	0.4		68	hypothetical; modified itt; R0013407:Results
72	A3	final	78.6 points	19.3		69	hypothetical; modified itt; R0013407:Figure 1
72	A3	final	55.5 points	3.0		68	hypothetical; modified itt; R0013407:Figure 2
72	A3 vs A1	md	10.8 points		5.4 to 16.3		hypothetical; modified itt; R0013407:Results
72	A3 vs A1	md	2.1 points		1.1 to 3.2		hypothetical; modified itt; R0013407:Results

Health related quality of life total score (any instrument) (13 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	4.7 points	14.3		66	hypothetical; modified itt; R0013407:Figure 4
72	A1	final	71.0 points	19.2		69	hypothetical; modified itt; R0013407:Figure 1
72	A1	change	-0.01 points	0.011		69	not stated; modified itt; registry:outcomes
72	A2 vs A1	md	8.5 points		3.5 to 13.4		hypothetical; modified itt; R0013407:Figure 1
72	A2	change	11.8 points	15.9		59	hypothetical; modified itt; R0013407:Figure 4
72	A2	final	79.6 points	15.8		63	hypothetical; modified itt; R0013407:Figure 1
72	A2	change	0.01 points	0.011		63	not stated; modified itt; registry:outcomes
72	A2 vs A1	md	0.03 points		0.00 to 0.06		not stated; modified itt; registry:outcomes
72	A3	change	11.9 points	15.8		65	hypothetical; modified itt; R0013407:Figure 4
72	A3	change	0.01 points	0.011		68	not stated; modified itt; registry:outcomes
72	A3 vs A1	md	0.02 points		-0.01 to 0.05		not stated; modified itt; registry:outcomes
72	A3	final	78.5 points	18.2		69	hypothetical; modified itt; R0013407:Figure 1
72	A3 vs A1	md	8.2 points		3.4 to 13.1		hypothetical; modified itt; R0013407:Figure 1

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 75	not stated; safety; registry:adverse_events
A2	events	8 / 73	not stated; safety; registry:adverse_events
A3	events	5 / 77	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	5 / 75	not stated; randomized; registry:flow
A2	events	7 / 73	not stated; randomized; registry:flow
A3	events	8 / 77	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 75	not stated; safety; registry:adverse_events
A2	events	10 / 73	not stated; safety; registry:adverse_events
A3	events	18 / 77	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	3 / 75	not stated; safety; registry:adverse_events
A2	events	5 / 73	not stated; safety; registry:adverse_events
A3	events	9 / 77	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 75	not stated; safety; registry:adverse_events
A2	events	9 / 73	not stated; safety; registry:adverse_events
A3	events	7 / 77	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	5 / 75	not stated; safety; registry:adverse_events
A2	events	12 / 73	not stated; safety; registry:adverse_events
A3	events	21 / 77	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (6 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	1 / 75	not stated; safety; gallbladder polyp; registry:adverse_events
A2	events	0 / 73	not stated; safety; gallbladder polyp; registry:adverse_events
A2	events	0 / 73	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 77	not stated; safety; gallbladder polyp; registry:adverse_events
A3	events	1 / 77	not stated; safety; cholelithiasis; registry:adverse_events

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	not stated; safety; registry:adverse_events
A2	events	0 / 73	not stated; safety; registry:adverse_events
A3	events	0 / 77	not stated; safety; registry:adverse_events