parallel randomized trial

NCT03131687

A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT03131687S000010

Design

Randomized: 318
Start year: 2017
Treatment: 26 weeks, follow-up 30 weeks
Countries: Poland, Puerto Rico, Slovakia, United States (47 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 to 75; T2D at least 6 months; HbA1c 7.0 to 10.5%; BMI 23 to 50; diet and exercise or metformin

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: Bayesian dose response model with ITP imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	metformin or diet and exercise; lifestyle: standard	51	51	42
A2	Tirzepatide 1 mg subcutaneous once weekly Tirzepatide 1 mg	metformin or diet and exercise; lifestyle: standard	53	52	44
A3	Tirzepatide 5 mg subcutaneous once weekly Tirzepatide 5 mg	metformin or diet and exercise; lifestyle: standard	55	55	47
A4	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg	metformin or diet and exercise; lifestyle: standard	52	51	44
A5	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	metformin or diet and exercise; lifestyle: standard	53	53	35
A6	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	metformin or diet and exercise; lifestyle: standard	54	54	46

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Tirzepatide 1 mg subcutaneous once weekly A2	Tirzepatide 5 mg subcutaneous once weekly A3	Tirzepatide 10 mg subcutaneous once weekly A4	Tirzepatide 15 mg subcutaneous once weekly A5	Dulaglutide 1.5 mg subcutaneous once weekly A6
age	mean (years)	56.6	57.4	57.9	56.5	56.0	58.7
age	sd (years)	8.9	8.9	8.2	9.9	7.6	7.8
asian	n	1	0	0	1	1	2
asian	percent	2	0	0	2	2	4
black	n	2	5	6	7	6	4
black	percent	4	10	11	14	11	8
bmi	mean (kg/m2)	32.4	32.9	32.9	32.6	32.2	32.4
bmi	sd (kg/m2)	6.0	6.1	5.7	5.8	6.2	5.4
diabetes duration	mean (years)	8.6	7.8	8.9	7.9	8.5	9.3
diabetes duration	sd (years)	7.0	5.4	5.7	5.8	6.1	7.1
egfr	mean (mL/min/1.73 m2)	95.3	95.6	92.2	93.7	91.8	90.7
egfr	sd (mL/min/1.73 m2)	15.3	16.8	17.2	18.6	17.9	17.6
female	n	22	23	21	21	31	30
female	percent	43	44	38	41	59	56
hba1c	mean (percent)	8.0	8.2	8.2	8.2	8.1	8.1
hba1c	sd (percent)	0.9	0.9	1.0	1.1	1.1	1.0
hispanic	n	27	25	22	26	23	19
hispanic	percent	59	52	49	57	46	41
metformin use	n	47	46	49	44	51	48
metformin use	percent	92.2	88.5	89.1	86.3	96.2	88.9
other race american indian alaska native	n	5	4	1	2	2	1
other race multiple	n	2	1	2	2	0	2
other race native hawaiian pacific islander	n	0	0	0	1	1	0
sbp	mean (mmHg)	124.8	126.8	127.8	125.8	126.0	125.7
sbp	se (mmHg)	1.82	1.80	1.75	1.82	1.79	1.77
waist	mean (cm)	107.7	109.9	110.1	109.6	107.6	108.5
waist	se (cm)	2.06	2.04	2.00	2.04	2.17	2.02
weight	mean (kg)	91.5	93.2	92.8	92.7	89.1	89.8
weight	sd (kg)	23.1	24.4	19.0	19.5	22.7	16.9
white	n	41	42	46	37	43	44
white	percent	80	81	84	74	81	83

Analyses this trial contributes to

Results

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

HbA1c change (30 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.10 percent	0.13			hypothetical; modified itt; R0016215:Supplement Table 1
26	A1	change	0.1 percent	0.16		41	hypothetical; modified itt; R0016215:Supplement Table 1
26	A1	change	-0.06 percent	0.14		44	hypothetical; modified itt; R0016215:Supplement Table 1
26	A2	change	-1.06 percent	0.11		45	hypothetical; modified itt; R0016215:Supplement Table 1
26	A2	change	-0.87 percent	0.09			hypothetical; modified itt; R0016215:Supplement Table 1
26	A2	change	-0.7 percent	0.16		44	hypothetical; modified itt; R0016215:Supplement Table 1
26	A2 vs A1	md	-1.00 percent		-1.22 to -0.79		hypothetical; modified itt; R0016215:Results
26	A2 vs A1	md	-0.8 percent		-1.2 to -0.4		hypothetical; modified itt; registry:outcomes
26	A2 vs A6	md	0.15 percent		-0.08 to 0.38		hypothetical; modified itt; R0016215:Results
26	A3	change	-1.73 percent	0.08		52	hypothetical; modified itt; R0016215:Supplement Table 1
26	A3	change	-1.84 percent	0.08			hypothetical; modified itt; R0016215:Supplement Table 1
26	A3	change	-1.6 percent	0.15		47	hypothetical; modified itt; R0016215:Supplement Table 1
26	A3 vs A1	md	-1.67 percent		-1.88 to -1.46		hypothetical; modified itt; R0016215:Results
26	A3 vs A1	md	-1.7 percent		-2.2 to -1.3		hypothetical; modified itt; registry:outcomes
26	A3 vs A6	md	-0.52 percent		-0.72 to -0.31		hypothetical; modified itt; R0016215:Results
26	A4	change	-1.89 percent	0.08		47	hypothetical; modified itt; R0016215:Supplement Table 1
26	A4	change	-2.18 percent	0.08			hypothetical; modified itt; R0016215:Supplement Table 1
26	A4	change	-2.0 percent	0.16		43	hypothetical; modified itt; R0016215:Supplement Table 1
26	A4 vs A1	md	-1.83 percent		-2.04 to -1.61		hypothetical; modified itt; R0016215:Results
26	A4 vs A1	md	-2.1 percent		-2.5 to -1.6		hypothetical; modified itt; registry:outcomes
26	A4 vs A6	md	-0.67 percent		-0.89 to -0.46		hypothetical; modified itt; R0016215:Results
26	A5	change	-1.94 percent	0.09		44	hypothetical; modified itt; R0016215:Supplement Table 1
26	A5	change	-2.32 percent	0.10			hypothetical; modified itt; R0016215:Supplement Table 1
26	A5	change	-2.4 percent	0.17		35	hypothetical; modified itt; R0016215:Supplement Table 1
26	A5 vs A1	md	-1.89 percent		-2.11 to -1.67		hypothetical; modified itt; R0016215:Results
26	A5 vs A1	md	-2.5 percent		-2.9 to -2.0		hypothetical; modified itt; registry:outcomes
26	A5 vs A6	md	-0.73 percent		-0.95 to -0.52		hypothetical; modified itt; R0016215:Results
26	A6	change	-1.21 percent	0.14		49	hypothetical; modified itt; R0016215:Supplement Table 1
26	A6	change	-1.25 percent	0.14			hypothetical; modified itt; R0016215:Supplement Table 1
26	A6	change	-1.1 percent	0.15		47	hypothetical; modified itt; R0016215:Supplement Table 1

Body weight change in kilograms (diabetes) (25 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.4 kg	0.81		41	hypothetical; modified itt; R0016215:Supplement Table 1
26	A1	change	-0.40 kg	0.27			hypothetical; modified itt; R0016215:Supplement Table 1
26	A1	change	-0.46 kg	0.26			hypothetical; modified itt; R0016215:Supplement Table 1
26	A2	change	-0.9 kg	0.80		44	hypothetical; modified itt; R0016215:Supplement Table 1
26	A2	change	-1.96 kg	0.20			hypothetical; modified itt; R0016215:Supplement Table 1
26	A2	change	-1.66 kg	0.18			hypothetical; modified itt; R0016215:Supplement Table 1
26	A2 vs A1	md	-0.5 kg		-2.7 to 1.7		hypothetical; modified itt; registry:outcomes
26	A3	change	-4.8 kg	0.77		48	hypothetical; modified itt; R0016215:Supplement Table 1
26	A3	change	-4.62 kg	0.19			hypothetical; modified itt; R0016215:Supplement Table 1
26	A3	change	-4.71 kg	0.20			hypothetical; modified itt; R0016215:Supplement Table 1
26	A3 vs A1	md	-4.4 kg		-6.6 to -2.3		hypothetical; modified itt; registry:outcomes
26	A3 vs A6	md	-2.1 kg				hypothetical; modified itt; R0016215:Results
26	A4	change	-8.7 kg	0.80		44	hypothetical; modified itt; R0016215:Supplement Table 1
26	A4	change	-6.88 kg	0.17			hypothetical; modified itt; R0016215:Supplement Table 1
26	A4	change	-7.76 kg	0.18			hypothetical; modified itt; R0016215:Supplement Table 1
26	A4 vs A1	md	-8.3 kg		-10.5 to -6.0		hypothetical; modified itt; registry:outcomes
26	A4 vs A6	md	-4.4 kg				hypothetical; modified itt; R0016215:Results
26	A5	change	-11.3 kg	0.88		35	hypothetical; modified itt; R0016215:Supplement Table 1
26	A5	change	-8.67 kg	0.23			hypothetical; modified itt; R0016215:Supplement Table 1
26	A5	change	-10.42 kg	0.26			hypothetical; modified itt; R0016215:Supplement Table 1
26	A5 vs A1	md	-10.9 kg		-13.3 to -8.6		hypothetical; modified itt; registry:outcomes
26	A5 vs A6	md	-6.2 kg				hypothetical; modified itt; R0016215:Results
26	A6	change	-2.7 kg	0.78		47	hypothetical; modified itt; R0016215:Supplement Table 1
26	A6	change	-2.48 kg	0.30			hypothetical; modified itt; R0016215:Supplement Table 1
26	A6	change	-2.65 kg	0.28			hypothetical; modified itt; R0016215:Supplement Table 1

HbA1c below 7 percent (15 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	11.8		6 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A6	or	0.46	0.20 to 1.05		hypothetical; modified itt; R0016215:Supplement Table 4
26	A2	responders	32.7		17 / 52	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A1	or	4.13	1.46 to 11.70		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A1	or	20.98	7.28 to 60.50		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3	responders	69.1		38 / 55	hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A6	or	2.34	1.02 to 5.36		hypothetical; modified itt; R0016215:Supplement Table 4
26	A4	responders	90.0		45 / 50	hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A1	or	89.44	24.41 to 327.76		hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A6	or	9.96	3.29 to 30.13		hypothetical; modified itt; R0016215:Supplement Table 4
26	A5	responders	77.4		41 / 53	hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A1	or	33.63	11.02 to 102.62		hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A6	or	3.75	1.53 to 9.16		hypothetical; modified itt; R0016215:Supplement Table 4
26	A6	responders	51.9		28 / 54	hypothetical; modified itt; R0016215:Supplement Table 4
26	A6 vs A1	or	8.98	3.23 to 24.96		hypothetical; modified itt; R0016215:Supplement Table 4

Level 2 or 3 hypoglycemia (participants) (12 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	2 / 51	not stated; safety; R0016215:Table 3
A1	events	0 / 51	not stated; safety; R0016215:Table 3
A2	events	0 / 52	not stated; safety; R0016215:Table 3
A2	events	1 / 52	not stated; safety; R0016215:Table 3
A3	events	0 / 55	not stated; safety; R0016215:Table 3
A3	events	4 / 55	not stated; safety; R0016215:Table 3
A4	events	0 / 51	not stated; safety; R0016215:Table 3
A4	events	5 / 51	not stated; safety; R0016215:Table 3
A5	events	4 / 53	not stated; safety; R0016215:Table 3
A5	events	0 / 53	not stated; safety; R0016215:Table 3
A6	events	0 / 54	not stated; safety; R0016215:Table 3
A6	events	2 / 54	not stated; safety; R0016215:Table 3

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Detail
26	A1	change	1.7 mmHg	1.98	not stated; safety; R0016215:Supplement Table 2
26	A2	change	0.0 mmHg	1.96	not stated; safety; R0016215:Supplement Table 2
26	A3	change	-2.6 mmHg	1.86	not stated; safety; R0016215:Supplement Table 2
26	A4	change	-1.3 mmHg	1.92	not stated; safety; R0016215:Supplement Table 2
26	A5	change	-1.0 mmHg	2.00	not stated; safety; R0016215:Supplement Table 2
26	A6	change	-1.5 mmHg	1.89	not stated; safety; R0016215:Supplement Table 2

Weight loss of 5 percent or more (15 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	0.0		0 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2	responders	13.5		7 / 52	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A1	or	17.03	0.97 to 300.06		hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A6	or	0.57	0.21 to 1.56		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3	responders	47.3		26 / 55	hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A1	or	90.91			hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A6	or	3.06	1.34 to 7.01		hypothetical; modified itt; R0016215:Supplement Table 4
26	A4	responders	70.6		36 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A1	or	236.84			hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A6	or	7.98	3.32 to 19.17		hypothetical; modified itt; R0016215:Supplement Table 4
26	A5	responders	62.3		33 / 53	hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A1	or	161.12			hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A6	or	5.43	2.33 to 12.64		hypothetical; modified itt; R0016215:Supplement Table 4
26	A6	responders	22.2		12 / 54	hypothetical; modified itt; R0016215:Supplement Table 4
26	A6 vs A1	or	29.68	1.74 to 505.34		hypothetical; modified itt; R0016215:Supplement Table 4

Weight loss of 10 percent or more (15 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	0.0		0 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2	responders	5.8		3 / 52	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A1	or	7.10	0.37 to 136.04		hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A6	or	0.61	0.15 to 2.46		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3	responders	16.4		9 / 55	hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A1	or	20.82	1.22 to 355.42		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A6	or	1.79	0.58 to 5.51		hypothetical; modified itt; R0016215:Supplement Table 4
26	A4	responders	39.2		20 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A1	or	67.57			hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A6	or	5.80	2.03 to 16.58		hypothetical; modified itt; R0016215:Supplement Table 4
26	A5	responders	37.7		20 / 53	hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A1	or	66.20			hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A6	or	5.68	1.99 to 16.23		hypothetical; modified itt; R0016215:Supplement Table 4
26	A6	responders	9.3		5 / 54	hypothetical; modified itt; R0016215:Supplement Table 4
26	A6 vs A1	or	11.66	0.65 to 209.16		hypothetical; modified itt; R0016215:Supplement Table 4

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	0.0		0 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A1	or	0.97	0.02 to 44.49		hypothetical; modified itt; R0016215:Supplement Table 4
26	A2	responders	0.0		0 / 52	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2 vs A6	or	0.33	0.01 to 7.68		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3	responders	5.5		3 / 55	hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A1	or	6.89	0.38 to 126.31		hypothetical; modified itt; R0016215:Supplement Table 4
26	A3 vs A6	or	2.36	0.35 to 16.04		hypothetical; modified itt; R0016215:Supplement Table 4
26	A4	responders	21.6		11 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A1	or	30.45	1.87 to 495.39		hypothetical; modified itt; R0016215:Supplement Table 4
26	A4 vs A6	or	10.44	1.85 to 58.77		hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A6	or	12.20	2.19 to 67.79		hypothetical; modified itt; R0016215:Supplement Table 4
26	A5	responders	24.5		13 / 53	hypothetical; modified itt; R0016215:Supplement Table 4
26	A5 vs A1	or	35.58	2.20 to 575.09		hypothetical; modified itt; R0016215:Supplement Table 4
26	A6	responders	1.9		1 / 54	hypothetical; modified itt; R0016215:Supplement Table 4
26	A6 vs A1	or	2.92	0.13 to 67.39		hypothetical; modified itt; R0016215:Supplement Table 4

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders				0 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2	responders				0 / 52	hypothetical; modified itt; R0016215:Supplement Table 4

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders				0 / 51	hypothetical; modified itt; R0016215:Supplement Table 4
26	A2	responders				0 / 52	hypothetical; modified itt; R0016215:Supplement Table 4

Acute kidney injury (6 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; registry:adverse_events
A2	events	0 / 52	not stated; safety; registry:adverse_events
A3	events	0 / 55	not stated; safety; registry:adverse_events
A4	events	1 / 51	not stated; safety; registry:adverse_events
A5	events	0 / 53	not stated; safety; registry:adverse_events
A6	events	0 / 54	not stated; safety; registry:adverse_events

All cause mortality (8 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; registry:adverse_events
A1	events	1 / 51	not stated; safety; R0016215:Table 3
A2	events	0 / 52	not stated; safety; R0016215:Table 3
A2	events	1 / 52	not stated; safety; registry:adverse_events
A3	events	0 / 55	not stated; safety; R0016215:Table 3
A4	events	0 / 51	not stated; safety; R0016215:Table 3
A5	events	0 / 53	not stated; safety; R0016215:Table 3
A6	events	0 / 54	not stated; safety; R0016215:Table 3

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A4	events				0 / 51	not stated; safety; R0016215:Results

Heart failure events (1 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A4	events				0 / 51	not stated; safety; R0016215:Results

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 51	not stated; safety; R0016215:Table 3
A2	events	2 / 52	not stated; safety; R0016215:Table 3
A3	events	1 / 55	not stated; safety; R0016215:Table 3
A4	events	3 / 51	not stated; safety; R0016215:Table 3
A5	events	2 / 53	not stated; safety; R0016215:Table 3
A6	events	3 / 54	not stated; safety; R0016215:Table 3

Discontinuation due to adverse events (13 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 51	not stated; safety; R0016215:Table 3
A1	events	2 / 51	not stated; safety; R0016215:Table 3
A1	events	0 / 51	not stated; randomized; registry:flow
A2	events	2 / 52	not stated; safety; R0016215:Table 3
A2	events	1 / 52	not stated; safety; R0016215:Table 3
A3	events	0 / 55	not stated; safety; R0016215:Table 3
A3	events	5 / 55	not stated; safety; R0016215:Table 3
A4	events	3 / 51	not stated; safety; R0016215:Table 3
A4	events	1 / 51	not stated; safety; R0016215:Table 3
A5	events	2 / 53	not stated; safety; R0016215:Table 3
A5	events	13 / 53	not stated; safety; R0016215:Table 3
A6	events	2 / 54	not stated; safety; R0016215:Table 3
A6	events	6 / 54	not stated; safety; R0016215:Table 3

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 51	not stated; safety; R0016215:Table 3
A2	events	2 / 52	not stated; safety; R0016215:Table 3
A3	events	11 / 55	not stated; safety; R0016215:Table 3
A4	events	11 / 51	not stated; safety; R0016215:Table 3
A5	events	21 / 53	not stated; safety; R0016215:Table 3
A6	events	16 / 54	not stated; safety; R0016215:Table 3

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 51	not stated; safety; R0016215:Table 3
A2	events	2 / 52	not stated; safety; R0016215:Table 3
A3	events	4 / 55	not stated; safety; R0016215:Table 3
A4	events	8 / 51	not stated; safety; R0016215:Table 3
A5	events	14 / 53	not stated; safety; R0016215:Table 3
A6	events	5 / 54	not stated; safety; R0016215:Table 3

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 51	not stated; safety; R0016215:Table 3
A2	events	7 / 52	not stated; safety; R0016215:Table 3
A3	events	13 / 55	not stated; safety; R0016215:Table 3
A4	events	12 / 51	not stated; safety; R0016215:Table 3
A5	events	17 / 53	not stated; safety; R0016215:Table 3
A6	events	9 / 54	not stated; safety; R0016215:Table 3

Constipation (6 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0016215:Table 3
A2	events	1 / 52	not stated; safety; R0016215:Table 3
A3	events	2 / 55	not stated; safety; R0016215:Table 3
A4	events	6 / 51	not stated; safety; R0016215:Table 3
A5	events	2 / 53	not stated; safety; R0016215:Table 3
A6	events	3 / 54	not stated; safety; R0016215:Table 3

Gallbladder and biliary disease (6 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; cholecystitis; R0016215:Table 3
A2	events	0 / 52	not stated; safety; cholecystitis; R0016215:Table 3
A3	events	0 / 55	not stated; safety; cholecystitis; R0016215:Table 3
A4	events	1 / 51	not stated; safety; cholecystitis; R0016215:Table 3
A5	events	0 / 53	not stated; safety; cholecystitis; R0016215:Table 3
A6	events	1 / 54	not stated; safety; cholecystitis; R0016215:Table 3

Acute pancreatitis (7 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0016215:Table 3
A2	events	0 / 52	not stated; safety; R0016215:Table 3
A3	events	2 / 55	not stated; safety; R0016215:Table 3
A3	events	1 / 55	not stated; safety; registry:adverse_events
A4	events	0 / 51	not stated; safety; R0016215:Table 3
A5	events	0 / 53	not stated; safety; R0016215:Table 3
A6	events	0 / 54	not stated; safety; R0016215:Table 3

Medullary thyroid carcinoma (6 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0016215:Results
A2	events	0 / 52	not stated; safety; R0016215:Results
A3	events	0 / 55	not stated; safety; R0016215:Results
A4	events	0 / 51	not stated; safety; R0016215:Results
A5	events	0 / 53	not stated; safety; R0016215:Results
A6	events	0 / 54	not stated; safety; R0016215:Results

Thyroid cancer (any) (6 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0016215:Results
A2	events	0 / 52	not stated; safety; R0016215:Results
A3	events	0 / 55	not stated; safety; R0016215:Results
A4	events	0 / 51	not stated; safety; R0016215:Results
A5	events	0 / 53	not stated; safety; R0016215:Results
A6	events	0 / 54	not stated; safety; R0016215:Results

Diabetic retinopathy complications (6 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0016215:Results
A2	events	0 / 52	not stated; safety; R0016215:Results
A3	events	0 / 55	not stated; safety; R0016215:Results
A4	events	0 / 51	not stated; safety; R0016215:Results
A5	events	0 / 53	not stated; safety; R0016215:Results
A6	events	0 / 54	not stated; safety; R0016215:Results

Death by suicide (6 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0016215:Table 3
A2	events	0 / 52	not stated; safety; R0016215:Table 3
A3	events	0 / 55	not stated; safety; R0016215:Table 3
A4	events	0 / 51	not stated; safety; R0016215:Table 3
A5	events	0 / 53	not stated; safety; R0016215:Table 3
A6	events	0 / 54	not stated; safety; R0016215:Table 3