parallel randomized trial

SURMOUNT-5

A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities

Overweight or obesity without diabetes (adults)NCT05822830S000093

Design

Randomized: 751
Start year: 2023
Treatment: 72 weeks, follow-up 76 weeks
Countries: United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults; BMI 30 or more, or 27 with complication; no diabetes

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Tirzepatide subcutaneous once weekly, maximum tolerated dose: 10 or 15 mg Tirzepatide 15 mg or MTD	lifestyle: standard	375	374
A2	Semaglutide maximum tolerated dose injection once weekly Semaglutide 2.4 mg or MTD	lifestyle: standard	376	376

Baseline characteristics

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

Characteristic	Statistic	Tirzepatide subcutaneous once weekly, maximum tolerated dose: 10 or 15 mg A1	Semaglutide maximum tolerated dose injection once weekly A2
age	mean (years)	45.0	44.4
age	sd (years)	12.9	12.7
asian	n	11	7
asian	percent	2.9	1.9
black	n	77	67
black	percent	20.6	17.8
bmi	mean (kg/m2)	39.4	39.4
bmi	sd (kg/m2)	7.42	7.72
egfr	mean (mL/min/1.73 m2)	104.6	106.0
egfr	sd (mL/min/1.73 m2)	17.43	16.88
female	n	242	243
female	percent	64.7	64.6
hba1c	mean (percent)	5.63	5.64
hba1c	sd (percent)	0.35	0.38
hispanic	n	93	103
hispanic	percent	24.9	27.4
other race american indian alaska native	n	6	0
other race american indian alaska native	percent	1.6
other race multiple	n	4	7
other race multiple	percent	1.1	1.9
other race native hawaiian pacific islander	n	0	0
sbp	mean (mmHg)	125.6	125.8
sbp	sd (mmHg)	13.56	12.48
waist	mean (cm)	117.7	118.8
waist	sd (cm)	16.14	17.56
weight	mean (kg)	112.7	113.4
weight	sd (kg)	24.81	26.33
white	n	276	295
white	percent	73.8	78.5

Analyses this trial contributes to

Results

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

Percent body weight change (12 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	percent change	-21.8 percent	0.60		367	hypothetical; other; registry:outcomes
72	A1 vs A2	md	-6.4 percent		-8.0 to -4.7		hypothetical; other; registry:outcomes
72	A1	percent change	-20.2 percent	0.59		318	not stated; other; registry:outcomes
72	A1 vs A2	md	-6.5 percent		-8.1 to -4.9		not stated; other; registry:outcomes
72	A1	percent change	-24.2 percent			30	hypothetical; modified itt; age:65_or_older; R0013402:Figure 1
72	A1 vs A2	md	-6.0 percent		-11.3 to -0.8		hypothetical; modified itt; age:65_or_older; R0013402:Figure 1
72	A1	percent change	-21.4 percent			337	hypothetical; modified itt; age:less_than_65; R0013402:Figure 1
72	A1 vs A2	md	-6.2 percent		-7.9 to -4.5		hypothetical; modified itt; age:less_than_65; R0013402:Figure 1
72	A2	percent change	-15.4 percent	0.60		373	hypothetical; other; registry:outcomes
72	A2	percent change	-18.2 percent			26	hypothetical; modified itt; age:65_or_older; R0013402:Figure 1
72	A2	percent change	-13.7 percent	0.59		318	not stated; other; registry:outcomes
72	A2	percent change	-15.2 percent			347	hypothetical; modified itt; age:less_than_65; R0013402:Figure 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	responders	87.7			318	not stated; other; registry:outcomes
72	A2	responders	66.7			318	not stated; other; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	responders	71.7			318	not stated; other; registry:outcomes
72	A2	responders	45.0			318	not stated; other; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	responders	55.0			318	not stated; other; registry:outcomes
72	A2	responders	31.1			318	not stated; other; registry:outcomes

Weight loss of 25 percent or more (2 lines; O11E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	responders	36.5			318	not stated; other; registry:outcomes
72	A2	responders	18.6			318	not stated; other; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 374	not stated; safety; registry:adverse_events
	A2	events				0 / 376	not stated; safety; registry:adverse_events

SF-36 physical component summary change (3 lines; O24A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	change	6.09 points		303	while on treatment; modified itt; R0009646:Figure 1
72	A1 vs A2	md	0.70 points	-0.03 to 1.44		while on treatment; modified itt; R0009646:Results
72	A2	change	5.38 points		287	while on treatment; modified itt; R0009646:Figure 1

Physical functioning (any instrument) (3 lines; O24B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	change	5.50 points		303	while on treatment; modified itt; R0009646:Figure 1
72	A1 vs A2	md	0.49 points	-0.20 to 1.19		while on treatment; modified itt; R0009646:Figure 1
72	A2	change	5.01 points		287	while on treatment; modified itt; R0009646:Figure 1

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				18 / 374	not stated; safety; registry:adverse_events
	A2	events				13 / 376	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				6 / 375	not stated; randomized; registry:flow
	A2	events				6 / 376	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				163 / 374	not stated; safety; registry:adverse_events
	A2	events				167 / 376	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				56 / 374	not stated; safety; registry:adverse_events
	A2	events				80 / 376	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				88 / 374	not stated; safety; registry:adverse_events
	A2	events				88 / 376	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				101 / 374	not stated; safety; registry:adverse_events
	A2	events				107 / 376	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (10 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 374	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	2 / 374	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	0 / 374	not stated; safety; bile duct stone; registry:adverse_events
A1	events	1 / 374	not stated; safety; gallbladder disorder; registry:adverse_events
A1	events	1 / 374	not stated; safety; cholecystitis; registry:adverse_events
A2	events	2 / 376	not stated; safety; bile duct stone; registry:adverse_events
A2	events	0 / 376	not stated; safety; gallbladder disorder; registry:adverse_events
A2	events	0 / 376	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 376	not stated; safety; cholecystitis; registry:adverse_events
A2	events	3 / 376	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 374	not stated; safety; obstructive pancreatitis; registry:adverse_events
	A2	events				1 / 376	not stated; safety; obstructive pancreatitis; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 374	not stated; safety; registry:adverse_events
	A2	events				0 / 376	not stated; safety; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 374	not stated; safety; volvulus; registry:adverse_events
	A2	events				0 / 376	not stated; safety; volvulus; registry:adverse_events