parallel randomized trial

SURMOUNT-2

Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)

Type 2 diabetes (adults)NCT04657003S001712

Design

Randomized: 938
Start year: 2021
Treatment: 72 weeks, follow-up 76 weeks
Countries: Argentina, Brazil, India, Japan, Russia, Taiwan, United States (77 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 or older; BMI 27 or more; type 2 diabetes with HbA1c 7 to 10 percent on diet or oral drugs

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: full analysis
Missing data: multiple imputation from retrieved dropouts

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg QW	diet and exercise or oral glucose lowering drugs; sulfonylurea dose halved at randomization; lifestyle: standard	312	312	283
A2	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg QW	diet and exercise or oral glucose lowering drugs; sulfonylurea dose halved at randomization; lifestyle: standard	311	311	268
A3	Placebo Placebo QW	diet and exercise or oral glucose lowering drugs; sulfonylurea dose halved at randomization; lifestyle: standard	315	315	268
A4	Pooled Tirzepatide 10 and 15 mg pooled	lifestyle: standard		623

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: 65 or older	n	54	54	57
age: 65 or older	percent	17.3	17.4	18.1
age	mean (years)	54.3	53.6	54.7
age	sd (years)	10.7	10.6	10.5
asian	n	44	42	39
asian	percent	14.1	13.5	12.4
black	n	33	22	22
black	percent	10.6	7.1	7.0
bmi: 30 to less than 35	n	92	114	105
bmi: 30 to less than 35	percent	29.5	36.7	33.3
bmi: 35 to less than 40	n	94	85	71
bmi: 35 to less than 40	percent	30.1	27.3	22.5
bmi: 40 or more	n	66	61	87
bmi: 40 or more	percent	21.2	19.6	27.6
bmi: less than 30	n	60	51	52
bmi: less than 30	percent	19.2	16.4	16.5
bmi	mean (kg/m2)	36.0	35.7	36.6
bmi	sd (kg/m2)	6.4	6.1	7.3
diabetes duration	mean (years)	8.8	8.0	8.8
diabetes duration	sd (years)	6.9	6.4	6.2
egfr	mean (mL/min/1.73 m2)	95.9	96.2	93.5
egfr	sd (mL/min/1.73 m2)	17.8	17.5	19.1
established cvd	n	24	29	44
established cvd	percent	7.7	9.3	14.0
female	n	158	159	159
female	percent	50.6	51.1	50.5
hba1c	mean (percent)	8.00	8.07	7.98
hba1c	sd (percent)	0.84	0.99	0.84
hispanic	n	184	189	188
hispanic	percent	59.0	60.8	59.7
metformin use	n	282	276	274
metformin use	percent	90.4	88.7	87.0
other race multiple	n	6	12	5
other race multiple	percent	1.9	3.9	1.6
other race native hawaiian pacific islander	n	1	1	1
other race native hawaiian pacific islander	percent	0.3	0.3	0.3
other sulfonylurea use	n	78	78	94
other sulfonylurea use	percent	25.0	25.1	29.8
sbp	mean (mmHg)	130.6	130.0	131.0
sbp	sd (mmHg)	12.2	12.3	11.9
sglt2i use	n	63	62	66
sglt2i use	percent	20.2	19.9	21.0
uacr	mean (mg/g)	17.4	17.3	16.4
uacr	se (mg/g)	1.5	1.5	1.4
waist	mean (cm)	114.2	114.6	116.0
waist	sd (cm)	14.1	13.1	15.7
weight	mean (kg)	100.9	99.6	101.7
weight	sd (kg)	20.9	20.1	22.3
white	n	228	234	248
white	percent	73.1	75.2	78.7

Results

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

HbA1c change (15 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1 vs A3	md	-1.55 percent		-1.74 to -1.37		treatment policy; full analysis; R0008662:Table 2
72	A1	change	-2.14 percent	0.06		301	hypothetical; modified itt; R0008662:Supplement Table S2
72	A1 vs A3	md	-1.97 percent		-2.15 to -1.80		hypothetical; modified itt; R0008662:Supplement Table S2
72	A1	change	-2.1 percent	0.2		14	hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A1 vs A3	md	-1.6 percent		-2.2 to -1.2		hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A1	change	-2.07 percent	0.06		312	treatment policy; full analysis; R0008662:Table 2
72	A2	change	-2.22 percent	0.06		300	hypothetical; modified itt; R0008662:Supplement Table S2
72	A2 vs A3	md	-2.06 percent		-2.24 to -1.88		hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	change	-2.08 percent	0.07		311	treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	md	-1.57 percent		-1.76 to -1.37		treatment policy; full analysis; R0008662:Table 2
72	A2	change	-2.2 percent	0.2		14	hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A2 vs A3	md	-1.8 percent		-2.3 to -1.3		hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A3	change	-0.4 percent	0.2		13	hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A3	change	-0.51 percent	0.07		315	treatment policy; full analysis; R0008662:Table 2
72	A3	change	-0.16 percent	0.07		290	hypothetical; modified itt; R0008662:Supplement Table S2

Body weight change in kilograms (diabetes) (15 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	-12.9 kg	0.6		312	treatment policy; full analysis; R0008662:Table 2
72	A1	change	-13.5 kg	0.5		309	hypothetical; modified itt; R0008662:Supplement Table S2
72	A1 vs A3	md	-10.3 kg		-11.7 to -8.8		hypothetical; modified itt; R0008662:Supplement Table S2
72	A1 vs A3	md	-9.7 kg		-11.2 to -8.2		treatment policy; full analysis; R0008662:Table 2
72	A1	change	-10.9 kg	1.5		14	hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A1 vs A3	md	-8.0 kg		-12.3 to -3.8		hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A2	change	-14.8 kg	0.5		311	treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	md	-11.6 kg		-13.1 to -10.2		treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	md	-12.4 kg		-13.8 to -11.0		hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	change	-15.6 kg	0.5		309	hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	change	-8.7 kg	1.5		14	hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A2 vs A3	md	-5.8 kg		-10.1 to -1.6		hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A3	change	-3.2 kg	0.5		315	treatment policy; full analysis; R0008662:Table 2
72	A3	change	-2.8 kg	1.5		13	hypothetical; modified itt; region:japan; R0015995:Supplement Table S1
72	A3	change	-3.2 kg	0.5		311	hypothetical; modified itt; R0008662:Supplement Table S2

HbA1c below 7 percent (10 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1 vs A3	or	12.6	7.9 to 20.1		treatment policy; full analysis; R0008662:Table 2
72	A1	responders			271 / 301	hypothetical; modified itt; R0008662:Supplement Table S2
72	A1 vs A3	or	28.0	17.2 to 45.6		hypothetical; modified itt; R0008662:Supplement Table S2
72	A1	responders	86.9		312	treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	or	10.7	6.5 to 17.4		treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	or	34.2	20.3 to 57.7		hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	responders			272 / 300	hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	responders	84.2		311	treatment policy; full analysis; R0008662:Table 2
72	A3	responders			85 / 290	hypothetical; modified itt; R0008662:Supplement Table S2
72	A3	responders	36.2		315	treatment policy; full analysis; R0008662:Table 2

Level 2 or 3 hypoglycemia (participants) (9 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	11 / 312	not stated; randomized; R0008662:Results
A1	events	6 / 312	not stated; randomized; R0008662:Results
A1	events	0 / 312	not stated; randomized; R0008662:Results
A2	events	15 / 311	not stated; randomized; R0008662:Results
A2	events	0 / 311	not stated; randomized; R0008662:Results
A2	events	13 / 311	not stated; randomized; R0008662:Results
A3	events	0 / 315	not stated; randomized; R0008662:Results
A3	events	4 / 315	not stated; randomized; R0008662:Results
A3	events	4 / 315	not stated; randomized; R0008662:Results

Level 2 or 3 hypoglycemia (episode rate) (3 lines; O04B)

Arm	Statistic	Estimate	Events / N	Detail
A1	rate	0.04	312	not stated; randomized; R0008662:Results
A2	rate	0.06	311	not stated; randomized; R0008662:Results
A3	rate	0.09	315	not stated; randomized; R0008662:Results

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	-5.9 mmHg				hypothetical; modified itt; R0008662:Supplement Figure S7A
72	A2	change	-7.7 mmHg				hypothetical; modified itt; R0008662:Supplement Figure S7A
72	A3	change	-1.0 mmHg	0.74		311	hypothetical; modified itt; registry:outcomes
72	A3	change	-1.2 mmHg				treatment policy; full analysis; R0008662:Results
72	A3	change	-1.2 mmHg				hypothetical; modified itt; R0008662:Supplement Figure S7A
72	A4	change	-6.3 mmHg				treatment policy; full analysis; R0008662:Results
72	A4 vs A3	md	-6.2 mmHg		-8.0 to -4.4		hypothetical; modified itt; registry:outcomes
72	A4	change	-7.2 mmHg	0.52		618	hypothetical; modified itt; registry:outcomes

Percent body weight change (10 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	percent change	-12.8 percent	0.6		312	treatment policy; full analysis; R0008662:Table 2
72	A1	percent change	-13.4 percent	0.5		309	hypothetical; modified itt; R0008662:Results
72	A1 vs A3	md	-9.6 percent		-11.1 to -8.1		treatment policy; full analysis; R0008662:Table 2
72	A1 vs A3	md	-10.1 percent		-11.5 to -8.8		hypothetical; modified itt; R0008662:Results
72	A2 vs A3	md	-12.4 percent		-13.7 to -11.0		hypothetical; modified itt; R0008662:Results
72	A2	percent change	-15.7 percent	0.5		309	hypothetical; modified itt; R0008662:Results
72	A2	percent change	-14.7 percent	0.5		311	treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	md	-11.6 percent		-13.0 to -10.1		treatment policy; full analysis; R0008662:Table 2
72	A3	percent change	-3.2 percent	0.5		315	treatment policy; full analysis; R0008662:Table 2
72	A3	percent change	-3.3 percent	0.5		311	hypothetical; modified itt; R0008662:Results

Weight loss of 5 percent or more (10 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	79.2		312	treatment policy; full analysis; R0008662:Table 2
72	A1	responders			252 / 309	hypothetical; modified itt; R0008662:Results
72	A1 vs A3	or	10.75	7.30 to 15.84		hypothetical; modified itt; registry:outcomes
72	A1 vs A3	or	8.3	5.6 to 12.3		treatment policy; full analysis; R0008662:Table 2
72	A2	responders			267 / 309	hypothetical; modified itt; R0008662:Results
72	A2 vs A3	or	15.28	10.08 to 23.14		hypothetical; modified itt; registry:outcomes
72	A2	responders	82.8		311	treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	or	10.5	6.8 to 16.1		treatment policy; full analysis; R0008662:Table 2
72	A3	responders	32.5		315	treatment policy; full analysis; R0008662:Table 2
72	A3	responders			95 / 311	hypothetical; modified itt; R0008662:Results

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	63.4		309	hypothetical; modified itt; R0008662:Figure 2D
72	A1	responders	60.5		312	treatment policy; full analysis; R0008662:Table 2
72	A1 vs A3	or	16.1	9.9 to 26.1		treatment policy; full analysis; R0008662:Table 2
72	A1 vs A3	or	20.94	13.06 to 33.58		hypothetical; modified itt; registry:outcomes
72	A2	responders	64.8		311	treatment policy; full analysis; R0008662:Table 2
72	A2	responders	69.6		309	hypothetical; modified itt; R0008662:Figure 2D
72	A2 vs A3	or	27.50	17.04 to 44.39		hypothetical; modified itt; registry:outcomes
72	A2 vs A3	or	19.4	11.9 to 31.7		treatment policy; full analysis; R0008662:Table 2
72	A3	responders	9.5		315	treatment policy; full analysis; R0008662:Table 2
72	A3	responders	8.7		311	hypothetical; modified itt; R0008662:Figure 2D

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1	responders	41.4		309	hypothetical; modified itt; R0008662:Figure 2D
72	A1 vs A3	or	28.38	13.81 to 58.31		hypothetical; modified itt; registry:outcomes
72	A1	responders	39.7		312	treatment policy; full analysis; R0008662:Table 2
72	A1 vs A3	or	25.2	12.2 to 52.1		treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	or	36.1	17.5 to 74.5		treatment policy; full analysis; R0008662:Table 2
72	A2	responders	48.0		311	treatment policy; full analysis; R0008662:Table 2
72	A2	responders	51.8		309	hypothetical; modified itt; R0008662:Figure 2D
72	A2 vs A3	or	43.60	21.20 to 89.67		hypothetical; modified itt; registry:outcomes
72	A3	responders	2.6		311	hypothetical; modified itt; R0008662:Figure 2D
72	A3	responders	2.7		315	treatment policy; full analysis; R0008662:Table 2

Weight loss of 20 percent or more (10 lines; O11D)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1 vs A3	or	25.6	8.7 to 75.4		treatment policy; full analysis; R0008662:Table 2
72	A1	responders	23.0		309	hypothetical; modified itt; R0008662:Figure 2D
72	A1 vs A3	or	28.54	9.73 to 83.73		hypothetical; modified itt; registry:outcomes
72	A1	responders	21.5		312	treatment policy; full analysis; R0008662:Table 2
72	A2	responders	30.8		311	treatment policy; full analysis; R0008662:Table 2
72	A2	responders	34.0		309	hypothetical; modified itt; R0008662:Figure 2D
72	A2 vs A3	or	49.68	17.03 to 144.94		hypothetical; modified itt; registry:outcomes
72	A2 vs A3	or	42.2	14.4 to 123.5		treatment policy; full analysis; R0008662:Table 2
72	A3	responders	1.0		315	treatment policy; full analysis; R0008662:Table 2
72	A3	responders	1.0		311	hypothetical; modified itt; R0008662:Figure 2D

Weight loss of 25 percent or more (8 lines; O11E)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
72	A1 vs A3	or	21.0	4.2 to 104.5		treatment policy; full analysis; R0008662:Table 2
72	A1	responders	10.0			hypothetical; modified itt; R0008662:Figure 2D
72	A1	responders	9.0		312	treatment policy; full analysis; R0008662:Table 2
72	A2 vs A3	or	39.1	8.0 to 190.6		treatment policy; full analysis; R0008662:Table 2
72	A2	responders	17.2			hypothetical; modified itt; R0008662:Figure 2D
72	A2	responders	15.5		311	treatment policy; full analysis; R0008662:Table 2
72	A3	responders	0.3		315	treatment policy; full analysis; R0008662:Table 2
72	A3	responders	0.3			hypothetical; modified itt; R0008662:Figure 2D

Acute kidney injury (3 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	3 / 312	not stated; safety; registry:adverse_events
A2	events	0 / 311	not stated; safety; registry:adverse_events
A3	events	1 / 315	not stated; safety; registry:adverse_events

All cause mortality (6 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	2 / 312	not stated; randomized; R0008662:Table 3
A1	events	0 / 14	not stated; safety; region:japan; R0015995:Table 2
A2	events	0 / 14	not stated; safety; region:japan; R0015995:Table 2
A2	events	0 / 311	not stated; randomized; R0008662:Table 3
A3	events	0 / 13	not stated; safety; region:japan; R0015995:Table 2
A3	events	0 / 315	not stated; randomized; R0008662:Table 3

Three point MACE (3 lines; O21)

Arm	Statistic	Events / N	Detail
A1	events	4 / 312	not stated; randomized; R0008662:Table 3
A2	events	3 / 311	not stated; randomized; R0008662:Table 3
A3	events	4 / 315	not stated; randomized; R0008662:Table 3

Hospitalization for heart failure (6 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 312	not stated; safety; cardiac failure congestive; registry:adverse_events
A1	events	0 / 312	not stated; safety; cardiac failure; registry:adverse_events
A2	events	1 / 311	not stated; safety; cardiac failure; registry:adverse_events
A2	events	0 / 311	not stated; safety; cardiac failure congestive; registry:adverse_events
A3	events	1 / 315	not stated; safety; cardiac failure congestive; registry:adverse_events
A3	events	0 / 315	not stated; safety; cardiac failure; registry:adverse_events

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

Week	Arm	Statistic	Estimate	Events / N	Detail
72	A1	change	3.1 points	281	hypothetical; modified itt; R0016962:Figure 1
72	A2	change	3.8 points	270	hypothetical; modified itt; R0016962:Figure 1
72	A3	change	1.3 points	270	hypothetical; modified itt; R0016962:Figure 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	change	14.3 points	1.0		282	hypothetical; modified itt; R0008662:Supplement Table S2
72	A1	change	3.4 points	0.4		281	hypothetical; modified itt; R0008662:Supplement Table S2
72	A1 vs A3	md	6.9 points		4.1 to 9.7		hypothetical; modified itt; R0008662:Supplement Table S2
72	A1 vs A3	md	1.8 points		0.7 to 2.9		hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	change	15.2 points	1.0		269	hypothetical; modified itt; R0008662:Supplement Table S2
72	A2	change	3.8 points	0.4		270	hypothetical; modified itt; R0008662:Supplement Table S2
72	A2 vs A3	md	7.8 points		5.0 to 10.7		hypothetical; modified itt; R0008662:Supplement Table S2
72	A2 vs A3	md	2.3 points		1.1 to 3.4		hypothetical; modified itt; R0008662:Supplement Table S2
72	A3	change	7.4 points	1.0		270	hypothetical; modified itt; R0008662:Supplement Table S2
72	A3	change	1.6 points	0.4		270	hypothetical; modified itt; R0008662:Supplement Table S2

Health related quality of life total score (any instrument) (6 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
72	A1	change	0.03 points	0.01	281	hypothetical; modified itt; R0016962:Results
72	A1	change	12.8 points		282	hypothetical; modified itt; R0016962:Figure 1
72	A2	change	0.04 points	0.01	265	hypothetical; modified itt; R0016962:Results
72	A2	change	14.4 points		269	hypothetical; modified itt; R0016962:Figure 1
72	A3	change	0.02 points	0.01	270	hypothetical; modified itt; R0016962:Results
72	A3	change	7.9 points		270	hypothetical; modified itt; R0016962:Figure 1

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	18 / 312	not stated; randomized; R0008662:Table 3
A2	events	27 / 311	not stated; randomized; R0008662:Table 3
A3	events	23 / 315	not stated; randomized; R0008662:Table 3

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 312	not stated; randomized; R0008662:Figure 1
A1	events	12 / 312	not stated; randomized; R0008662:Table 3
A2	events	23 / 311	not stated; randomized; R0008662:Table 3
A2	events	5 / 311	not stated; randomized; R0008662:Figure 1
A3	events	12 / 315	not stated; randomized; R0008662:Table 3
A3	events	5 / 315	not stated; randomized; R0008662:Figure 1

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	63 / 312	not stated; randomized; R0008662:Table 3
A2	events	68 / 311	not stated; randomized; R0008662:Table 3
A3	events	20 / 315	not stated; randomized; R0008662:Table 3

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	34 / 312	not stated; randomized; R0008662:Table 3
A2	events	41 / 311	not stated; randomized; R0008662:Table 3
A3	events	10 / 315	not stated; randomized; R0008662:Table 3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	62 / 312	not stated; randomized; R0008662:Table 3
A2	events	67 / 311	not stated; randomized; R0008662:Table 3
A3	events	28 / 315	not stated; randomized; R0008662:Table 3

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	25 / 312	not stated; randomized; R0008662:Table 3
A2	events	28 / 311	not stated; randomized; R0008662:Table 3
A3	events	13 / 315	not stated; randomized; R0008662:Table 3

Discontinuation due to gastrointestinal adverse events (9 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 312	not stated; randomized; nausea; R0008662:Table 3
A1	events	0 / 312	not stated; randomized; diarrhea; R0008662:Table 3
A1	events	2 / 312	not stated; randomized; vomiting; R0008662:Table 3
A2	events	5 / 311	not stated; randomized; diarrhea; R0008662:Table 3
A2	events	4 / 311	not stated; randomized; nausea; R0008662:Table 3
A2	events	0 / 311	not stated; randomized; vomiting; R0008662:Table 3
A3	events	0 / 315	not stated; randomized; nausea; R0008662:Table 3
A3	events	0 / 315	not stated; randomized; diarrhea; R0008662:Table 3
A3	events	0 / 315	not stated; randomized; vomiting; R0008662:Table 3

Gallbladder and biliary disease (9 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 312	not stated; safety; biliary colic; registry:adverse_events
A1	events	2 / 312	not stated; randomized; cholelithiasis; R0008662:Table 3
A1	events	1 / 312	not stated; randomized; acute cholecystitis; R0008662:Table 3
A2	events	0 / 311	not stated; safety; biliary colic; registry:adverse_events
A2	events	3 / 311	not stated; randomized; acute cholecystitis; R0008662:Table 3
A2	events	6 / 311	not stated; randomized; cholelithiasis; R0008662:Table 3
A3	events	4 / 315	not stated; randomized; cholelithiasis; R0008662:Table 3
A3	events	0 / 315	not stated; safety; biliary colic; registry:adverse_events
A3	events	2 / 315	not stated; randomized; acute cholecystitis; R0008662:Table 3

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 312	not stated; randomized; R0008662:Table 3
A2	events	2 / 311	not stated; randomized; R0008662:Table 3
A3	events	1 / 315	not stated; randomized; R0008662:Table 3

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 312	not stated; randomized; R0008662:Results
A2	events	0 / 311	not stated; randomized; R0008662:Results
A3	events	0 / 315	not stated; randomized; R0008662:Results

Diabetic retinopathy complications (3 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	1 / 312	not stated; randomized; R0008662:Table 3
A2	events	0 / 311	not stated; randomized; R0008662:Table 3
A3	events	1 / 315	not stated; randomized; R0008662:Table 3

Suicidal ideation or behavior (3 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 312	not stated; randomized; mdd/suicidal ideation; R0008662:Table 3
A2	events	0 / 311	not stated; randomized; mdd/suicidal ideation; R0008662:Table 3
A3	events	1 / 315	not stated; randomized; mdd/suicidal ideation; R0008662:Table 3

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 312	not stated; randomized; R0008662:Table 3
A2	events	0 / 311	not stated; randomized; R0008662:Table 3
A3	events	0 / 315	not stated; randomized; R0008662:Table 3

Pancreatic cancer (3 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 312	not stated; randomized; R0008662:Results
A2	events	0 / 311	not stated; randomized; R0008662:Results
A3	events	0 / 315	not stated; randomized; R0008662:Results

Any cancer (3 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	1 / 312	not stated; randomized; R0008662:Table 3
A2	events	3 / 311	not stated; randomized; R0008662:Table 3
A3	events	7 / 315	not stated; randomized; R0008662:Table 3