parallel randomized trial

NCT05579977

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM

Type 2 diabetes (adults)Overweight or obesity without diabetes (adults)NCT05579977S000448

Design

Randomized: 902
Start year: 2022
Treatment: 32 weeks
Countries: Bulgaria, Czech Republic, Hungary, Poland, Canada, Japan, United States
Sponsor: Pfizer (industry)
Eligibility: age 18 to 75; T2D cohort on metformin, HbA1c 7.0 to 10.0, BMI 23 or more; obesity cohort BMI 30 or more without 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 (T2D cohort)	metformin; lifestyle: not reported	75	75
A10	Lotiglipron 140 mg tablet once daily Lotiglipron 140 mg (obesity cohort)	lifestyle: not reported	64	64
A11	lotiglipron Lotiglipron 200 mg five step (obesity cohort)	lifestyle: not reported	65	65
A12	lotiglipron Lotiglipron 200 mg four step (obesity cohort)	lifestyle: not reported	66	66
A13	Lotiglipron 260 mg tablet once daily Lotiglipron 260 mg (obesity cohort)	lifestyle: not reported	64	64
A2	Lotiglipron 20 mg tablet once daily Lotiglipron 20 mg (T2D cohort)	metformin; lifestyle: not reported	73	73
A3	Lotiglipron 40 mg tablet once daily Lotiglipron 40 mg (T2D cohort)	metformin; lifestyle: not reported	72	72
A4	lotiglipron Lotiglipron 80 mg (T2D cohort)	metformin; lifestyle: not reported	73	73
A5	Lotiglipron 160 mg tablet once daily Lotiglipron 160 mg (T2D cohort)	metformin; lifestyle: not reported	73	72
A6	lotiglipron Lotiglipron 260 mg (T2D cohort)	metformin; lifestyle: not reported	74	74
A7	Semaglutide 14 mg oral once daily (original tablet) Oral semaglutide 14 mg (T2D cohort, open label)	metformin; lifestyle: not reported	73	73
A8	Placebo Placebo (obesity cohort)	lifestyle: not reported	64	64
A9	Lotiglipron 80 mg tablet once daily Lotiglipron 80 mg (obesity cohort)	lifestyle: not reported	66	66

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Lotiglipron 20 mg tablet once daily A2	Lotiglipron 40 mg tablet once daily A3	Lotiglipron 80 mg (T2D cohort) A4	Lotiglipron 160 mg tablet once daily A5	Lotiglipron 260 mg (T2D cohort) A6	Semaglutide 14 mg oral once daily (original tablet) A7	Placebo A8	Lotiglipron 80 mg tablet once daily A9	Lotiglipron 140 mg tablet once daily A10	Lotiglipron 200 mg five step (obesity cohort) A11	Lotiglipron 200 mg four step (obesity cohort) A12	Lotiglipron 260 mg tablet once daily A13
age	mean (years)	60.0	58.8	58.6	57.7	59.6	60.3	59.8	50.9	49.3	48.1	47.6	50.0	48.5
age	sd (years)	10.17	10.17	8.47	9.21	9.71	9.76	8.89	13.30	12.97	12.44	13.49	10.74	11.68
asian	n	12	14	17	15	13	14	11	4	3	3	3	4	6
asian	percent	16.0	19.2	23.6	20.5	18.1	18.9	15.1	6.3	4.5	4.7	4.6	6.1	9.4
black	n	4	2	4	4	5	5	5	4	6	15	6	5	4
black	percent	5.3	2.7	5.6	5.5	6.9	6.8	6.8	6.3	9.1	23.4	9.2	7.6	6.3
bmi	mean (kg/m2)	34.3	32.4	33.9	33.8	33.5	34.6	33.3	37.9	37.1	38.4	37.9	37.0	38.3
bmi	sd (kg/m2)	6.15	6.12	7.19	7.30	7.68	7.07	6.62	6.69	5.70	7.07	5.68	4.47	7.28
diabetes duration	mean (years)	8.2	9.2	7.3	8.6	8.5	9.1	9.9
diabetes duration	sd (years)	6.41	6.17	5.40	6.12	6.07	6.75	6.50
female	n	42	30	29	31	33	31	36	36	38	45	36	42	40
female	percent	56.0	41.1	40.3	42.5	45.8	41.9	49.3	56.3	57.6	70.3	55.4	63.6	62.5
hba1c	mean (percent)	8.04	8.14	7.86	7.89	8.02	7.80	8.01	5.38	5.37	5.54	5.42	5.42	5.46
hba1c	sd (percent)	0.971	0.898	0.925	0.948	0.926	0.788	0.929	0.436	0.371	0.382	0.406	0.384	0.408
hispanic	n	14	13	8	7	14	10	8	5	8	10	14	12	10
hispanic	percent	18.7	17.8	11.1	9.6	19.4	13.5	11.0	7.8	12.1	15.6	21.5	18.2	15.6
other race american indian alaska native	n	1	0	0	0	0	0	0	1	1	1	0	0	1
other race american indian alaska native	percent	1.3							1.6	1.5	1.6			1.6
other race multiple	n	0	0	0	0	0	0	0	0	0	0	0	1	1
other race multiple	percent												1.5	1.6
other race native hawaiian pacific islander	n	0	0	0	0	0	0	0	0	0	1	0	0	0
other race native hawaiian pacific islander	percent										1.6
weight	mean (kg)	95.7	92.2	96.2	97.6	93.5	96.0	94.6	109.7	105.7	106.7	108.2	104.1	109.3
weight	sd (kg)	23.11	18.70	25.12	23.37	23.55	22.60	21.96	22.11	22.28	25.33	21.67	15.92	24.92
white	n	58	57	51	54	54	54	57	55	56	44	56	55	52
white	percent	77.3	78.1	70.8	74.0	75.0	73.0	78.1	85.9	84.8	68.8	86.2	83.3	81.3

Analyses this trial contributes to

Results

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

HbA1c change (13 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	change	-0.07 percent	-0.25 to 0.11	24	hypothetical; modified itt; R0004106:Supplement Table S2
16	A2	change	-1.03 percent	-1.20 to -0.85	30	hypothetical; modified itt; R0004106:Supplement Table S2
16	A2 vs A1	md	-0.95 percent	-1.20 to -0.70		hypothetical; modified itt; R0004106:Supplement Table S2
16	A3	change	-1.37 percent	-1.56 to -1.19	21	hypothetical; modified itt; R0004106:Supplement Table S2
16	A3 vs A1	md	-1.30 percent	-1.55 to -1.04		hypothetical; modified itt; R0004106:Supplement Table S2
16	A4	change	-1.44 percent	-1.63 to -1.26	22	hypothetical; modified itt; R0004106:Supplement Table S2
16	A4 vs A1	md	-1.37 percent	-1.62 to -1.11		hypothetical; modified itt; R0004106:Supplement Table S2
16	A5	change	-1.34 percent	-1.52 to -1.16	25	hypothetical; modified itt; R0004106:Supplement Table S2
16	A5 vs A1	md	-1.26 percent	-1.52 to -1.01		hypothetical; modified itt; R0004106:Supplement Table S2
16	A6	change	-1.36 percent	-1.55 to -1.18	21	hypothetical; modified itt; R0004106:Supplement Table S2
16	A6 vs A1	md	-1.29 percent	-1.55 to -1.03		hypothetical; modified itt; R0004106:Supplement Table S2
16	A7	change	-0.94 percent	-1.12 to -0.76	24	hypothetical; modified itt; R0004106:Supplement Table S2
16	A7 vs A1	md	-0.86 percent	-1.12 to -0.61		hypothetical; modified itt; R0004106:Supplement Table S2

Percent body weight change (24 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	percent change	-1.05 percent	-1.87 to -0.24	24	hypothetical; modified itt; R0004106:Supplement Table S2
16	A2	percent change	-1.96 percent	-2.74 to -1.18	30	hypothetical; modified itt; R0004106:Supplement Table S2
16	A2 vs A1	md	-0.91 percent	-2.04 to 0.22		hypothetical; modified itt; R0004106:Supplement Table S2
16	A3	percent change	-3.84 percent	-4.69 to -2.99	21	hypothetical; modified itt; R0004106:Supplement Table S2
16	A3 vs A1	md	-2.79 percent	-3.97 to -1.61		hypothetical; modified itt; R0004106:Supplement Table S2
16	A4	percent change	-3.78 percent	-4.62 to -2.94	22	hypothetical; modified itt; R0004106:Supplement Table S2
16	A4 vs A1	md	-2.72 percent	-3.90 to -1.55		hypothetical; modified itt; R0004106:Supplement Table S2
16	A5	percent change	-3.79 percent	-4.60 to -2.97	25	hypothetical; modified itt; R0004106:Supplement Table S2
16	A5 vs A1	md	-2.73 percent	-3.89 to -1.58		hypothetical; modified itt; R0004106:Supplement Table S2
16	A6	percent change	-4.80 percent	-5.66 to -3.94	21	hypothetical; modified itt; R0004106:Supplement Table S2
16	A6 vs A1	md	-3.74 percent	-4.93 to -2.56		hypothetical; modified itt; R0004106:Supplement Table S2
16	A7	percent change	-3.66 percent	-4.47 to -2.85	25	hypothetical; modified itt; R0004106:Supplement Table S2
16	A7 vs A1	md	-2.61 percent	-3.76 to -1.46		hypothetical; modified itt; R0004106:Supplement Table S2
20	A10	percent change	-6.21 percent	-7.29 to -5.13	37	hypothetical; modified itt; R0004106:Supplement Table S2
20	A10 vs A8	md	-4.37 percent	-5.84 to -2.89		hypothetical; modified itt; R0004106:Supplement Table S2
20	A11	percent change	-7.47 percent	-8.50 to -6.43	38	hypothetical; modified itt; R0004106:Supplement Table S2
20	A11 vs A8	md	-5.63 percent	-7.07 to -4.18		hypothetical; modified itt; R0004106:Supplement Table S2
20	A12	percent change	-6.88 percent	-7.93 to -5.83	31	hypothetical; modified itt; R0004106:Supplement Table S2
20	A12 vs A8	md	-5.04 percent	-6.50 to -3.58		hypothetical; modified itt; R0004106:Supplement Table S2
20	A13	percent change	-7.26 percent	-8.35 to -6.16	28	hypothetical; modified itt; R0004106:Supplement Table S2
20	A13 vs A8	md	-5.42 percent	-6.91 to -3.93		hypothetical; modified itt; R0004106:Supplement Table S2
20	A8	percent change	-1.84 percent	-2.85 to -0.83	45	hypothetical; modified itt; R0004106:Supplement Table S2
20	A9	percent change	-4.28 percent	-5.31 to -3.25	44	hypothetical; modified itt; R0004106:Supplement Table S2
20	A9 vs A8	md	-2.44 percent	-3.88 to -1.00		hypothetical; modified itt; R0004106:Supplement Table S2

Acute kidney injury (13 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	while on treatment; safety; registry:adverse_events
A10	events	0 / 64	while on treatment; safety; registry:adverse_events
A11	events	0 / 65	while on treatment; safety; registry:adverse_events
A12	events	0 / 66	while on treatment; safety; registry:adverse_events
A13	events	0 / 64	while on treatment; safety; registry:adverse_events
A2	events	0 / 73	while on treatment; safety; registry:adverse_events
A3	events	3 / 72	while on treatment; safety; registry:adverse_events
A4	events	0 / 73	while on treatment; safety; registry:adverse_events
A5	events	0 / 72	while on treatment; safety; registry:adverse_events
A6	events	0 / 74	while on treatment; safety; registry:adverse_events
A7	events	0 / 73	while on treatment; safety; registry:adverse_events
A8	events	0 / 64	while on treatment; safety; registry:adverse_events
A9	events	0 / 66	while on treatment; safety; registry:adverse_events

All cause mortality (13 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	1 / 75	not stated; safety; R0004106:Supplement Table S3
A10	events	0 / 64	not stated; safety; R0004106:Supplement Table S3
A11	events	0 / 65	not stated; safety; R0004106:Supplement Table S3
A12	events	0 / 66	not stated; safety; R0004106:Supplement Table S3
A13	events	0 / 64	not stated; safety; R0004106:Supplement Table S3
A2	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A3	events	0 / 72	not stated; safety; R0004106:Supplement Table S3
A4	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A5	events	0 / 72	not stated; safety; R0004106:Supplement Table S3
A6	events	0 / 74	not stated; safety; R0004106:Supplement Table S3
A7	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A8	events	0 / 64	not stated; safety; R0004106:Supplement Table S3
A9	events	0 / 66	not stated; safety; R0004106:Supplement Table S3

Serious adverse events (13 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 75	not stated; safety; R0004106:Supplement Table S3
A10	events	2 / 64	not stated; safety; R0004106:Supplement Table S3
A11	events	1 / 65	not stated; safety; R0004106:Supplement Table S3
A12	events	2 / 66	not stated; safety; R0004106:Supplement Table S3
A13	events	2 / 64	not stated; safety; R0004106:Supplement Table S3
A2	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A3	events	3 / 72	not stated; safety; R0004106:Supplement Table S3
A4	events	3 / 73	not stated; safety; R0004106:Supplement Table S3
A5	events	1 / 72	not stated; safety; R0004106:Supplement Table S3
A6	events	2 / 74	not stated; safety; R0004106:Supplement Table S3
A7	events	1 / 73	not stated; safety; R0004106:Supplement Table S3
A8	events	1 / 64	not stated; safety; R0004106:Supplement Table S3
A9	events	2 / 66	not stated; safety; R0004106:Supplement Table S3

Discontinuation due to adverse events (39 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	not stated; safety; R0004106:Supplement Table S3
A1	events	1 / 75	not stated; safety; R0004106:Supplement Table S3
A1	events	0 / 75	not stated; randomized; registry:flow
A10	events	19 / 64	not stated; safety; R0004106:Supplement Table S3
A10	events	1 / 64	not stated; safety; R0004106:Supplement Table S3
A10	events	20 / 64	not stated; randomized; registry:flow
A11	events	15 / 65	not stated; safety; R0004106:Supplement Table S3
A11	events	0 / 65	not stated; safety; R0004106:Supplement Table S3
A11	events	15 / 65	not stated; randomized; registry:flow
A12	events	24 / 66	not stated; safety; R0004106:Supplement Table S3
A12	events	0 / 66	not stated; safety; R0004106:Supplement Table S3
A12	events	24 / 66	not stated; randomized; registry:flow
A13	events	22 / 64	not stated; safety; R0004106:Supplement Table S3
A13	events	1 / 64	not stated; safety; R0004106:Supplement Table S3
A13	events	23 / 64	not stated; randomized; registry:flow
A2	events	3 / 73	not stated; safety; R0004106:Supplement Table S3
A2	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A2	events	3 / 73	not stated; randomized; registry:flow
A3	events	11 / 72	not stated; safety; R0004106:Supplement Table S3
A3	events	0 / 72	not stated; safety; R0004106:Supplement Table S3
A3	events	11 / 72	not stated; randomized; registry:flow
A4	events	10 / 73	not stated; safety; R0004106:Supplement Table S3
A4	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A4	events	10 / 73	not stated; randomized; registry:flow
A5	events	5 / 72	not stated; safety; R0004106:Supplement Table S3
A5	events	0 / 72	not stated; safety; R0004106:Supplement Table S3
A5	events	5 / 73	not stated; randomized; registry:flow
A6	events	17 / 74	not stated; safety; R0004106:Supplement Table S3
A6	events	0 / 74	not stated; safety; R0004106:Supplement Table S3
A6	events	17 / 74	not stated; randomized; registry:flow
A7	events	5 / 73	not stated; safety; R0004106:Supplement Table S3
A7	events	0 / 73	not stated; safety; R0004106:Supplement Table S3
A7	events	5 / 73	not stated; randomized; registry:flow
A8	events	5 / 64	not stated; safety; R0004106:Supplement Table S3
A8	events	0 / 64	not stated; safety; R0004106:Supplement Table S3
A8	events	5 / 64	not stated; randomized; registry:flow
A9	events	12 / 66	not stated; safety; R0004106:Supplement Table S3
A9	events	0 / 66	not stated; safety; R0004106:Supplement Table S3
A9	events	12 / 66	not stated; randomized; registry:flow

Nausea (13 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 75	not stated; safety; R0004106:Table 2
A10	events	30 / 64	not stated; safety; R0004106:Table 2
A11	events	38 / 65	not stated; safety; R0004106:Table 2
A12	events	40 / 66	not stated; safety; R0004106:Table 2
A13	events	32 / 64	not stated; safety; R0004106:Table 2
A2	events	11 / 73	not stated; safety; R0004106:Table 2
A3	events	17 / 72	not stated; safety; R0004106:Table 2
A4	events	21 / 73	not stated; safety; R0004106:Table 2
A5	events	14 / 72	not stated; safety; R0004106:Table 2
A6	events	19 / 74	not stated; safety; R0004106:Table 2
A7	events	10 / 73	not stated; safety; R0004106:Table 2
A8	events	8 / 64	not stated; safety; R0004106:Table 2
A9	events	34 / 66	not stated; safety; R0004106:Table 2

Vomiting (13 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 75	not stated; safety; R0004106:Table 2
A10	events	10 / 64	not stated; safety; R0004106:Table 2
A11	events	21 / 65	not stated; safety; R0004106:Table 2
A12	events	19 / 66	not stated; safety; R0004106:Table 2
A13	events	22 / 64	not stated; safety; R0004106:Table 2
A2	events	1 / 73	not stated; safety; R0004106:Table 2
A3	events	6 / 72	not stated; safety; R0004106:Table 2
A4	events	11 / 73	not stated; safety; R0004106:Table 2
A5	events	6 / 72	not stated; safety; R0004106:Table 2
A6	events	11 / 74	not stated; safety; R0004106:Table 2
A7	events	6 / 73	not stated; safety; R0004106:Table 2
A8	events	1 / 64	not stated; safety; R0004106:Table 2
A9	events	7 / 66	not stated; safety; R0004106:Table 2

Diarrhea (13 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	1 / 75	not stated; safety; R0004106:Table 2
A10	events	10 / 64	not stated; safety; R0004106:Table 2
A11	events	16 / 65	not stated; safety; R0004106:Table 2
A12	events	17 / 66	not stated; safety; R0004106:Table 2
A13	events	17 / 64	not stated; safety; R0004106:Table 2
A2	events	8 / 73	not stated; safety; R0004106:Table 2
A3	events	9 / 72	not stated; safety; R0004106:Table 2
A4	events	8 / 73	not stated; safety; R0004106:Table 2
A5	events	4 / 72	not stated; safety; R0004106:Table 2
A6	events	8 / 74	not stated; safety; R0004106:Table 2
A7	events	6 / 73	not stated; safety; R0004106:Table 2
A8	events	12 / 64	not stated; safety; R0004106:Table 2
A9	events	10 / 66	not stated; safety; R0004106:Table 2

Constipation (13 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	1 / 75	not stated; safety; R0004106:Table 2
A10	events	15 / 64	not stated; safety; R0004106:Table 2
A11	events	15 / 65	not stated; safety; R0004106:Table 2
A12	events	23 / 66	not stated; safety; R0004106:Table 2
A13	events	17 / 64	not stated; safety; R0004106:Table 2
A2	events	2 / 73	not stated; safety; R0004106:Table 2
A3	events	7 / 72	not stated; safety; R0004106:Table 2
A4	events	3 / 73	not stated; safety; R0004106:Table 2
A5	events	4 / 72	not stated; safety; R0004106:Table 2
A6	events	6 / 74	not stated; safety; R0004106:Table 2
A7	events	4 / 73	not stated; safety; R0004106:Table 2
A8	events	5 / 64	not stated; safety; R0004106:Table 2
A9	events	14 / 66	not stated; safety; R0004106:Table 2

Gallbladder and biliary disease (26 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	while on treatment; safety; cholecystitis; registry:adverse_events
A1	events	0 / 75	while on treatment; safety; cholelithiasis; registry:adverse_events
A10	events	0 / 64	while on treatment; safety; cholelithiasis; registry:adverse_events
A10	events	0 / 64	while on treatment; safety; cholecystitis; registry:adverse_events
A11	events	0 / 65	while on treatment; safety; cholecystitis; registry:adverse_events
A11	events	2 / 65	while on treatment; safety; cholelithiasis; registry:adverse_events
A12	events	0 / 66	while on treatment; safety; cholelithiasis; registry:adverse_events
A12	events	0 / 66	while on treatment; safety; cholecystitis; registry:adverse_events
A13	events	0 / 64	while on treatment; safety; cholelithiasis; registry:adverse_events
A13	events	0 / 64	while on treatment; safety; cholecystitis; registry:adverse_events
A2	events	0 / 73	while on treatment; safety; cholecystitis; registry:adverse_events
A2	events	0 / 73	while on treatment; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 72	while on treatment; safety; cholelithiasis; registry:adverse_events
A3	events	1 / 72	while on treatment; safety; cholecystitis; registry:adverse_events
A4	events	0 / 73	while on treatment; safety; cholelithiasis; registry:adverse_events
A4	events	0 / 73	while on treatment; safety; cholecystitis; registry:adverse_events
A5	events	0 / 72	while on treatment; safety; cholecystitis; registry:adverse_events
A5	events	0 / 72	while on treatment; safety; cholelithiasis; registry:adverse_events
A6	events	0 / 74	while on treatment; safety; cholecystitis; registry:adverse_events
A6	events	0 / 74	while on treatment; safety; cholelithiasis; registry:adverse_events
A7	events	0 / 73	while on treatment; safety; cholelithiasis; registry:adverse_events
A7	events	0 / 73	while on treatment; safety; cholecystitis; registry:adverse_events
A8	events	0 / 64	while on treatment; safety; cholecystitis; registry:adverse_events
A8	events	0 / 64	while on treatment; safety; cholelithiasis; registry:adverse_events
A9	events	0 / 66	while on treatment; safety; cholelithiasis; registry:adverse_events
A9	events	0 / 66	while on treatment; safety; cholecystitis; registry:adverse_events

Acute pancreatitis (13 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	not stated; safety; R0004106:Results
A10	events	0 / 64	not stated; safety; R0004106:Results
A11	events	0 / 65	not stated; safety; R0004106:Results
A12	events	0 / 66	not stated; safety; R0004106:Results
A13	events	0 / 64	not stated; safety; R0004106:Results
A2	events	0 / 73	not stated; safety; R0004106:Results
A3	events	0 / 72	not stated; safety; R0004106:Results
A4	events	0 / 73	not stated; safety; R0004106:Results
A5	events	0 / 72	not stated; safety; R0004106:Results
A6	events	0 / 74	not stated; safety; R0004106:Results
A7	events	0 / 73	not stated; safety; R0004106:Results
A8	events	0 / 64	not stated; safety; R0004106:Results
A9	events	0 / 66	not stated; safety; R0004106:Results

Suicidal ideation or behavior (19 lines; O35A)

Arm	Statistic	Events / N	Detail
A10	events	0 / 64	not stated; safety; preparatory acts towards imminent suicidal behavior; registry:outcomes
A10	events	0 / 64	not stated; safety; suicidal ideation; registry:outcomes
A10	events	0 / 64	not stated; safety; suicide attempt; registry:outcomes
A11	events	0 / 65	not stated; safety; preparatory acts towards imminent suicidal behavior; registry:outcomes
A11	events	0 / 65	not stated; safety; suicidal ideation; registry:outcomes
A11	events	0 / 65	not stated; safety; suicide attempt; registry:outcomes
A12	events	0 / 66	not stated; safety; preparatory acts towards imminent suicidal behavior; registry:outcomes
A12	events	0 / 66	not stated; safety; suicidal ideation; registry:outcomes
A12	events	0 / 66	not stated; safety; suicide attempt; registry:outcomes
A13	events	0 / 64	not stated; safety; preparatory acts towards imminent suicidal behavior; registry:outcomes
A13	events	1 /	not stated; other; suicidal ideation; R0004106:Results
A13	events	1 / 64	not stated; safety; suicidal ideation; registry:outcomes
A13	events	0 / 64	not stated; safety; suicide attempt; registry:outcomes
A8	events	1 / 64	not stated; safety; preparatory acts towards imminent suicidal behavior; registry:outcomes
A8	events	0 / 64	not stated; safety; suicidal ideation; registry:outcomes
A8	events	0 / 64	not stated; safety; suicide attempt; registry:outcomes
A9	events	0 / 66	not stated; safety; preparatory acts towards imminent suicidal behavior; registry:outcomes
A9	events	0 / 66	not stated; safety; suicidal ideation; registry:outcomes
A9	events	0 / 66	not stated; safety; suicide attempt; registry:outcomes

Death by suicide (6 lines; O35B)

Arm	Statistic	Events / N	Detail
A10	events	0 / 64	not stated; safety; registry:outcomes
A11	events	0 / 65	not stated; safety; registry:outcomes
A12	events	0 / 66	not stated; safety; registry:outcomes
A13	events	0 / 64	not stated; safety; registry:outcomes
A8	events	0 / 64	not stated; safety; registry:outcomes
A9	events	0 / 66	not stated; safety; registry:outcomes

Intestinal obstruction or ileus (13 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 75	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A10	events	0 / 64	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A11	events	0 / 65	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A12	events	0 / 66	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A13	events	0 / 64	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A2	events	0 / 73	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A3	events	0 / 72	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A4	events	1 / 73	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A5	events	0 / 72	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A6	events	0 / 74	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A7	events	0 / 73	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A8	events	0 / 64	while on treatment; safety; small intestinal obstruction; registry:adverse_events
A9	events	0 / 66	while on treatment; safety; small intestinal obstruction; registry:adverse_events