parallel randomized trial

SURMOUNT-CN

Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)

Overweight or obesity without diabetes (adults)NCT05024032S001086

Design

Randomized: 210
Start year: 2021
Treatment: 52 weeks, follow-up 56 weeks
Countries: China
Sponsor: Eli Lilly and Company (industry)
Eligibility: Chinese adults; BMI 28 or more, or 24 or more with a weight related comorbidity; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: mixed model per registry

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg	lifestyle: standard	70	70
A2	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	lifestyle: standard	71	68
A3	Placebo Placebo	lifestyle: standard	69	68

Baseline characteristics

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

Characteristic	Statistic	Tirzepatide 10 mg subcutaneous once weekly A1	Tirzepatide 15 mg subcutaneous once weekly A2	Placebo A3
age	mean (years)	34.70	35.80	37.80
age	sd (years)	7.24	9.33	10.24
asian	n	70	71	69
black	n	0	0	0
female	n	35	35	33
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
weight	mean (kg)	92.2	91.3	92.0
weight	sd (kg)	16.2	16.2	15.8
white	n	0	0	0

Analyses this trial contributes to

Results

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

Percent body weight change (14 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	percent change	-14.4 percent	0.98		70	not stated; modified itt; registry:outcomes
52	A1	percent change	-15.326 percent	8.038		56	not stated; completers; R0007857:Supplement Table S2
52	A1 vs A3	md	-12.0 percent		-14.8 to -9.3		not stated; modified itt; registry:outcomes
52	A2	percent change	-19.9 percent	1.01		68	not stated; modified itt; registry:outcomes
52	A2	percent change	-19.884 percent	8.776		49	not stated; completers; R0007857:Supplement Table S2
52	A2 vs A3	md	-17.5 percent		-20.3 to -14.8		not stated; modified itt; registry:outcomes
52	A3	percent change	-2.4 percent	1.00		68	not stated; modified itt; registry:outcomes
52	A3	percent change	-3.798 percent	6.083		42	not stated; completers; R0007857:Supplement Table S2
56	A1	percent change	-12.815 percent	7.187		54	not stated; completers; R0007857:Supplement Table S2
56	A2	percent change	-17.869 percent	8.882		48	not stated; completers; R0007857:Supplement Table S2
56	A3	percent change	-2.871 percent	6.576		40	not stated; completers; R0007857:Supplement Table S2
78	A1	percent change	-8.738 percent	6.927		54	not stated; completers; R0007857:Supplement Table S2
78	A2	percent change	-10.567 percent	10.231		49	not stated; completers; R0007857:Supplement Table S2
78	A3	percent change	-2.472 percent	7.032		39	not stated; completers; R0007857:Supplement Table S2

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1	responders	91.43		70	not stated; modified itt; registry:outcomes
52	A1 vs A3	or	23.11	8.80 to 60.69		not stated; modified itt; registry:outcomes
52	A2	responders	92.65		68	not stated; modified itt; registry:outcomes
52	A2 vs A3	or	26.53	9.61 to 73.24		not stated; modified itt; registry:outcomes
52	A3	responders	29.41		68	not stated; modified itt; registry:outcomes

Weight loss of 10 percent or more (8 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1	responders	70.0		70	not stated; modified itt; registry:outcomes
52	A1 vs A3	or	13.19	5.63 to 30.89		not stated; modified itt; registry:outcomes
52	A2	responders	83.82		68	not stated; modified itt; registry:outcomes
52	A2 vs A3	or	28.58	11.23 to 72.71		not stated; modified itt; registry:outcomes
52	A3	responders	14.71		68	not stated; modified itt; registry:outcomes
78	A1	responders	42.6		54	not stated; completers; R0007857:Results
78	A2	responders	53.1		49	not stated; completers; R0007857:Results
78	A3	responders	15.4		39	not stated; completers; R0007857:Results

Weight loss of 15 percent or more (10 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1	responders	48.57		70	not stated; modified itt; registry:outcomes
52	A1	responders	54.4		57	not stated; completers; R0007857:Results
52	A1 vs A3	or	25.64	6.68 to 98.49		not stated; modified itt; registry:outcomes
52	A2	responders	72.06		68	not stated; modified itt; registry:outcomes
52	A2	responders	68.6		51	not stated; completers; R0007857:Results
52	A2 vs A3	or	69.79	17.69 to 275.37		not stated; modified itt; registry:outcomes
52	A3	responders	2.94		68	not stated; modified itt; registry:outcomes
78	A1	responders	16.7		54	not stated; completers; R0007857:Results
78	A2	responders	34.7		49	not stated; completers; R0007857:Results
78	A3	responders	5.1		39	not stated; completers; R0007857:Results

Weight loss of 20 percent or more (6 lines; O11D)

Week	Arm	Statistic	Events / N	Detail
52	A1	responders	15 / 57	not stated; completers; R0007857:Supplement Table S2
52	A2	responders	23 / 51	not stated; completers; R0007857:Supplement Table S2
52	A3	responders	0 / 44	not stated; completers; R0007857:Supplement Table S2
78	A1	responders	5 / 54	not stated; completers; R0007857:Supplement Table S2
78	A2	responders	10 / 49	not stated; completers; R0007857:Supplement Table S2
78	A3	responders	0 / 39	not stated; completers; R0007857:Supplement Table S2

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 70	not stated; safety; registry:adverse_events
A2	events	0 / 71	not stated; safety; registry:adverse_events
A3	events	0 / 69	not stated; safety; registry:adverse_events

Physical functioning (any instrument) (10 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	11.2 points	1.44		62	not stated; modified itt; registry:outcomes
52	A1	change	2.0 points	0.40		62	not stated; modified itt; registry:outcomes
52	A1 vs A3	md	7.8 points		3.7 to 11.8		not stated; modified itt; registry:outcomes
52	A1 vs A3	md	1.2 points		0.0 to 2.3		not stated; modified itt; registry:outcomes
52	A2	change	12.0 points	1.48		58	not stated; modified itt; registry:outcomes
52	A2	change	1.9 points	0.42		58	not stated; modified itt; registry:outcomes
52	A2 vs A3	md	8.5 points		4.4 to 12.7		not stated; modified itt; registry:outcomes
52	A2 vs A3	md	1.2 points		0.0 to 2.3		not stated; modified itt; registry:outcomes
52	A3	change	3.5 points	1.48		58	not stated; modified itt; registry:outcomes
52	A3	change	0.8 points	0.41		58	not stated; modified itt; registry:outcomes

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	3 / 70	not stated; safety; registry:adverse_events
A2	events	8 / 71	not stated; safety; registry:adverse_events
A3	events	6 / 69	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 70	not stated; randomized; registry:flow
A2	events	1 / 71	not stated; randomized; registry:flow
A3	events	0 / 69	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	21 / 70	not stated; safety; registry:adverse_events
A2	events	23 / 71	not stated; safety; registry:adverse_events
A3	events	4 / 69	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	8 / 70	not stated; safety; registry:adverse_events
A2	events	14 / 71	not stated; safety; registry:adverse_events
A3	events	3 / 69	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	28 / 70	not stated; safety; registry:adverse_events
A2	events	29 / 71	not stated; safety; registry:adverse_events
A3	events	6 / 69	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (3 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 70	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 71	not stated; safety; cholecystitis acute; registry:adverse_events
A3	events	0 / 69	not stated; safety; cholecystitis acute; registry:adverse_events

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 70	not stated; safety; papillary thyroid cancer; registry:adverse_events
A2	events	1 / 71	not stated; safety; papillary thyroid cancer; registry:adverse_events
A3	events	0 / 69	not stated; safety; papillary thyroid cancer; registry:adverse_events