parallel randomized trial

NCT06256562

A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients

Overweight or obesity without diabetes (adults)NCT06256562S002790

Design

Randomized: 340
Start year: 2023
Treatment: 30 weeks, follow-up 33 weeks
Countries: China (20 sites)
Sponsor: Gan & Lee Pharmaceuticals (industry)
Eligibility: age 18 to 75; BMI 24 to <28 kg/m2 with comorbidity or 28 or more (Chinese criteria); no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: treatment policy
Analysis population: modified itt
Missing data: multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Bofanglutide 12 mg injection every 2 weeks Bofanglutide 12 mg Q2W	lifestyle: standard	52	52
A2	Bofanglutide 18 mg injection every 2 weeks Bofanglutide 18 mg Q2W	lifestyle: standard	53	53
A3	Bofanglutide 24 mg injection every 2 weeks Bofanglutide 24 mg Q2W	lifestyle: standard	52	52
A4	Bofanglutide 48 mg injection every 2 weeks Bofanglutide 48 mg Q2W	lifestyle: standard	64	64
A5	Bofanglutide 24 mg injection once weekly Bofanglutide 24 mg QW	lifestyle: standard	53	53
A6	Placebo Placebo	lifestyle: standard	66	66

Baseline characteristics

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

Characteristic	Statistic	Bofanglutide 12 mg injection every 2 weeks A1	Bofanglutide 18 mg injection every 2 weeks A2	Bofanglutide 24 mg injection every 2 weeks A3	Bofanglutide 48 mg injection every 2 weeks A4	Bofanglutide 24 mg injection once weekly A5	Placebo A6
age	mean (years)	32.3	33.0	33.7	32.8	32.8	33.7
age	sd (years)	7.0	7.6	6.3	7.8	7.4	7.2
asian	n	52	53	52	64	53	66
asian	percent	100	100	100	100	100	100
bmi: 24 to less than 28	n	1	5	3	8	5	5
bmi: 24 to less than 28	percent	1.9	9.4	5.8	12.5	9.4	7.6
bmi: 28 or more	n	51	48	49	56	48	61
bmi: 28 or more	percent	98.1	90.6	94.2	87.5	90.6	92.4
bmi	mean (kg/m2)	33.7	32.4	33.3	33.0	33.1	33.8
bmi	sd (kg/m2)	4.9	4.1	4.1	4.9	4.5	5.0
female	n	20	26	20	35	23	31
female	percent	38.5	49.1	38.5	54.7	43.4	47.0
hba1c	mean (percent)	5.60	5.48	5.57	5.54	5.67	5.62
hba1c	sd (percent)	0.39	0.41	0.42	0.34	0.49	0.37
sbp	mean (mmHg)	122.5	121.5	122.9	123.4	119.9	119.7
sbp	sd (mmHg)	9.60	11.41	10.53	10.37	11.44	10.31
waist	mean (cm)	107.7	105.1	108.1	105.5	106.3	108.2
waist	sd (cm)	13.2	11.2	11.0	14.0	12.2	13.1
weight	mean (kg)	97.22	93.01	97.17	94.87	94.52	96.90
weight	sd (kg)	21.22	14.59	17.22	23.17	18.60	21.46

Analyses this trial contributes to

Results

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

Systolic blood pressure change (11 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1 vs A6	md	-3.31 mmHg		-7.47 to 0.84		treatment policy; modified itt; R0002409:Supplement Table S4
30	A1	change	-3.42 mmHg	1.56		52	treatment policy; modified itt; R0002409:Supplement Table S4
30	A2	change	-8.13 mmHg	1.51		53	treatment policy; modified itt; R0002409:Supplement Table S4
30	A2 vs A6	md	-8.03 mmHg		-12.17 to -3.89		treatment policy; modified itt; R0002409:Supplement Table S4
30	A3	change	-4.82 mmHg	1.58		52	treatment policy; modified itt; R0002409:Supplement Table S4
30	A3 vs A6	md	-4.71 mmHg		-8.84 to -0.58		treatment policy; modified itt; R0002409:Supplement Table S4
30	A4 vs A6	md	-10.05 mmHg		-14.12 to -5.98		treatment policy; modified itt; R0002409:Supplement Table S4
30	A4	change	-10.16 mmHg	1.54		64	treatment policy; modified itt; R0002409:Supplement Table S4
30	A5 vs A6	md	-6.85 mmHg		-11.16 to -2.53		treatment policy; modified itt; R0002409:Supplement Table S4
30	A5	change	-6.95 mmHg	1.64		53	treatment policy; modified itt; R0002409:Supplement Table S4
30	A6	change	-0.10 mmHg	1.54		66	treatment policy; modified itt; R0002409:Supplement Table S4

Percent body weight change (74 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	percent change	-11.15 percent	1.04		41	not stated; per protocol; R0002409:Supplement Table S2
30	A1	percent change	-9.98 percent	0.94			not stated; modified itt; R0002409:Supplement Table S2
30	A1 vs A6	md	-8.57 percent		-11.03 to -6.10		not stated; modified itt; R0002409:Supplement Table S2
30	A1 vs A6	md	-10.17 percent		-12.86 to -7.47		not stated; per protocol; R0002409:Supplement Table S2
30	A1 vs A6	md	-9.05 percent		-11.50 to -6.59		not stated; modified itt; R0002409:Supplement Table S2
30	A1 vs A6	md	-8.60 percent		-11.18 to -6.01		treatment policy; modified itt; R0002409:Table 2
30	A1	percent change	-0.94 percent		-22.30 to 20.41		treatment policy; modified itt; bmi:24_to_less_than_27; R0002409:Supplement Table S3
30	A1	percent change	-10.25 percent		-12.34 to -8.15		treatment policy; modified itt; bmi:30_or_more; R0002409:Supplement Table S3
30	A1	percent change	-9.75 percent	0.99		52	treatment policy; modified itt; R0002409:Table 2
30	A1	percent change	-7.79 percent		-10.08 to -5.49		treatment policy; modified itt; sex:male; R0002409:Supplement Table S3
30	A1	percent change	-12.65 percent		-16.00 to -9.29		treatment policy; modified itt; sex:female; R0002409:Supplement Table S3
30	A1	percent change	-7.83 percent		-12.61 to -3.05		treatment policy; modified itt; bmi:27_to_less_than_30; R0002409:Supplement Table S3
30	A1	percent change	-9.72 percent	0.94			not stated; modified itt; R0002409:Supplement Table S2
30	A2	percent change	-11.59 percent		-13.75 to -9.43		treatment policy; modified itt; bmi:30_or_more; R0002409:Supplement Table S3
30	A2	percent change	-15.45 percent		-19.45 to -11.45		treatment policy; modified itt; bmi:27_to_less_than_30; R0002409:Supplement Table S3
30	A2	percent change	-14.02 percent		-24.48 to -3.57		treatment policy; modified itt; bmi:24_to_less_than_27; R0002409:Supplement Table S3
30	A2	percent change	-12.50 percent	0.93			not stated; modified itt; R0002409:Supplement Table S2
30	A2	percent change	-13.22 percent	0.95		49	not stated; per protocol; R0002409:Supplement Table S2
30	A2	percent change	-12.74 percent	0.91			not stated; modified itt; R0002409:Supplement Table S2
30	A2 vs A6	md	-11.35 percent		-13.80 to -8.89		not stated; modified itt; R0002409:Supplement Table S2
30	A2 vs A6	md	-12.23 percent		-14.80 to -9.67		not stated; per protocol; R0002409:Supplement Table S2
30	A2 vs A6	md	-11.81 percent		-14.22 to -9.39		not stated; modified itt; R0002409:Supplement Table S2
30	A2	percent change	-11.85 percent		-14.33 to -9.37		treatment policy; modified itt; sex:male; R0002409:Supplement Table S3
30	A2	percent change	-13.52 percent		-16.35 to -10.68		treatment policy; modified itt; sex:female; R0002409:Supplement Table S3
30	A2	percent change	-12.55 percent	0.96		53	treatment policy; modified itt; R0002409:Table 2
30	A2 vs A6	md	-11.39 percent		-13.92 to -8.87		treatment policy; modified itt; R0002409:Table 2
30	A3 vs A6	md	-12.19 percent		-14.65 to -9.73		not stated; modified itt; R0002409:Supplement Table S2
30	A3	percent change	-14.85 percent		-18.08 to -11.62		treatment policy; modified itt; sex:female; R0002409:Supplement Table S3
30	A3 vs A6	md	-12.50 percent		-15.07 to -9.94		treatment policy; modified itt; R0002409:Table 2
30	A3	percent change	-13.82 percent	0.93			not stated; modified itt; R0002409:Supplement Table S2
30	A3	percent change	-14.25 percent	1.01		43	not stated; per protocol; R0002409:Supplement Table S2
30	A3	percent change	-13.40 percent		-15.52 to -11.27		treatment policy; modified itt; bmi:30_or_more; R0002409:Supplement Table S3
30	A3	percent change	-13.34 percent	0.94			not stated; modified itt; R0002409:Supplement Table S2
30	A3	percent change	-22.70 percent		-34.79 to -10.61		treatment policy; modified itt; bmi:24_to_less_than_27; R0002409:Supplement Table S3
30	A3	percent change	-13.86 percent		-18.37 to -9.35		treatment policy; modified itt; bmi:27_to_less_than_30; R0002409:Supplement Table S3
30	A3 vs A6	md	-12.89 percent		-15.32 to -10.45		not stated; modified itt; R0002409:Supplement Table S2
30	A3 vs A6	md	-13.27 percent		-15.93 to -10.61		not stated; per protocol; R0002409:Supplement Table S2
30	A3	percent change	-12.86 percent		-15.15 to -10.57		treatment policy; modified itt; sex:male; R0002409:Supplement Table S3
30	A3	percent change	-13.66 percent	0.97		52	treatment policy; modified itt; R0002409:Table 2
30	A4	percent change	-16.04 percent		-18.19 to -13.89		treatment policy; modified itt; bmi:30_or_more; R0002409:Supplement Table S3
30	A4	percent change	-15.09 percent	0.84			not stated; modified itt; R0002409:Supplement Table S2
30	A4	percent change	-17.29 percent	0.99		45	not stated; per protocol; R0002409:Supplement Table S2
30	A4	percent change	-17.57 percent	0.87			not stated; modified itt; R0002409:Supplement Table S2
30	A4 vs A6	md	-13.94 percent		-16.27 to -11.61		not stated; modified itt; R0002409:Supplement Table S2
30	A4 vs A6	md	-16.30 percent		-18.93 to -13.68		not stated; per protocol; R0002409:Supplement Table S2
30	A4 vs A6	md	-16.64 percent		-19.00 to -14.28		not stated; modified itt; R0002409:Supplement Table S2
30	A4	percent change	-16.09 percent	0.94		64	treatment policy; modified itt; R0002409:Table 2
30	A4 vs A6	md	-14.94 percent		-17.45 to -12.42		treatment policy; modified itt; R0002409:Table 2
30	A4	percent change	-17.74 percent		-23.57 to -11.92		treatment policy; modified itt; bmi:24_to_less_than_27; R0002409:Supplement Table S3
30	A4	percent change	-16.01 percent		-20.41 to -11.61		treatment policy; modified itt; bmi:27_to_less_than_30; R0002409:Supplement Table S3
30	A4	percent change	-16.94 percent		-19.59 to -14.29		treatment policy; modified itt; sex:female; R0002409:Supplement Table S3
30	A4	percent change	-15.03 percent		-17.61 to -12.44		treatment policy; modified itt; sex:male; R0002409:Supplement Table S3
30	A5	percent change	-16.86 percent		-25.67 to -8.04		treatment policy; modified itt; bmi:24_to_less_than_27; R0002409:Supplement Table S3
30	A5	percent change	-18.82 percent		-21.91 to -15.73		treatment policy; modified itt; sex:female; R0002409:Supplement Table S3
30	A5 vs A6	md	-15.54 percent		-18.10 to -12.98		treatment policy; modified itt; R0002409:Table 2
30	A5	percent change	-17.30 percent	0.93			not stated; modified itt; R0002409:Supplement Table S2
30	A5	percent change	-17.78 percent	1.01		43	not stated; per protocol; R0002409:Supplement Table S2
30	A5	percent change	-16.28 percent	0.93			not stated; modified itt; R0002409:Supplement Table S2
30	A5	percent change	-16.69 percent	0.98		53	treatment policy; modified itt; R0002409:Table 2
30	A5	percent change	-15.10 percent		-17.48 to -12.72		treatment policy; modified itt; sex:male; R0002409:Supplement Table S3
30	A5	percent change	-16.36 percent		-18.58 to -14.14		treatment policy; modified itt; bmi:30_or_more; R0002409:Supplement Table S3
30	A5	percent change	-17.69 percent		-21.79 to -13.59		treatment policy; modified itt; bmi:27_to_less_than_30; R0002409:Supplement Table S3
30	A5 vs A6	md	-16.37 percent		-18.81 to -13.93		not stated; modified itt; R0002409:Supplement Table S2
30	A5 vs A6	md	-16.80 percent		-19.45 to -14.14		not stated; per protocol; R0002409:Supplement Table S2
30	A5 vs A6	md	-15.12 percent		-17.57 to -12.67		not stated; modified itt; R0002409:Supplement Table S2
30	A6	percent change	-1.15 percent	0.87		66	treatment policy; modified itt; R0002409:Table 2
30	A6	percent change	1.85 percent		-2.14 to 5.85		treatment policy; modified itt; bmi:27_to_less_than_30; R0002409:Supplement Table S3
30	A6	percent change	-0.93 percent	0.83			not stated; modified itt; R0002409:Supplement Table S2
30	A6	percent change	-0.99 percent	0.91		53	not stated; per protocol; R0002409:Supplement Table S2
30	A6	percent change	-1.16 percent	0.83			not stated; modified itt; R0002409:Supplement Table S2
30	A6	percent change	-2.07 percent		-4.00 to -0.14		treatment policy; modified itt; bmi:30_or_more; R0002409:Supplement Table S3
30	A6	percent change	-1.18 percent		-3.86 to 1.50		treatment policy; modified itt; sex:female; R0002409:Supplement Table S3
30	A6	percent change	3.29 percent		-3.86 to 10.45		treatment policy; modified itt; bmi:24_to_less_than_27; R0002409:Supplement Table S3
30	A6	percent change	-1.11 percent		-3.29 to 1.07		treatment policy; modified itt; sex:male; R0002409:Supplement Table S3

Weight loss of 5 percent or more (11 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
30	A1	responders	74.0		52	treatment policy; modified itt; R0002409:Table 2
30	A1 vs A6	rd	58.4	43.5 to 73.3		treatment policy; modified itt; R0002409:Table 2
30	A2	responders	87.5		53	treatment policy; modified itt; R0002409:Table 2
30	A2 vs A6	rd	71.7	58.8 to 84.6		treatment policy; modified itt; R0002409:Table 2
30	A3	responders	89.1		52	treatment policy; modified itt; R0002409:Table 2
30	A3 vs A6	rd	73.7	62.1 to 85.4		treatment policy; modified itt; R0002409:Table 2
30	A4	responders	96.8		64	treatment policy; modified itt; R0002409:Table 2
30	A4 vs A6	rd	81.6	72.5 to 90.7		treatment policy; modified itt; R0002409:Table 2
30	A5 vs A6	rd	77.2	65.6 to 88.8		treatment policy; modified itt; R0002409:Table 2
30	A5	responders	93.0		53	treatment policy; modified itt; R0002409:Table 2
30	A6	responders	18.5		66	treatment policy; modified itt; R0002409:Table 2

Weight loss of 10 percent or more (11 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
30	A1	responders	51.9		52	treatment policy; modified itt; R0002409:Table 2
30	A1 vs A6	rd	46.0	32.7 to 59.2		treatment policy; modified itt; R0002409:Table 2
30	A2	responders	62.2		53	treatment policy; modified itt; R0002409:Table 2
30	A2 vs A6	rd	55.8	42.5 to 69.0		treatment policy; modified itt; R0002409:Table 2
30	A3	responders	74.7		52	treatment policy; modified itt; R0002409:Table 2
30	A3 vs A6	rd	68.9	54.7 to 83.2		treatment policy; modified itt; R0002409:Table 2
30	A4	responders	82.7		64	treatment policy; modified itt; R0002409:Table 2
30	A4 vs A6	rd	81.3	70.4 to 92.3		treatment policy; modified itt; R0002409:Table 2
30	A5	responders	88.7		53	treatment policy; modified itt; R0002409:Table 2
30	A5 vs A6	rd	82.1	71.4 to 92.9		treatment policy; modified itt; R0002409:Table 2
30	A6	responders	6.7		66	treatment policy; modified itt; R0002409:Table 2

Weight loss of 15 percent or more (11 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
30	A1	responders	25.7		52	treatment policy; modified itt; R0002409:Table 2
30	A1 vs A6	rd	20.1	7.5 to 32.7		treatment policy; modified itt; R0002409:Table 2
30	A2	responders	36.4		53	treatment policy; modified itt; R0002409:Table 2
30	A2 vs A6	rd	32.5	20.3 to 44.7		treatment policy; modified itt; R0002409:Table 2
30	A3	responders	42.4		52	treatment policy; modified itt; R0002409:Table 2
30	A3 vs A6	rd	37.6	22.5 to 52.8		treatment policy; modified itt; R0002409:Table 2
30	A4 vs A6	rd	59.2	46.2 to 72.2		treatment policy; modified itt; R0002409:Table 2
30	A4	responders	61.5		64	treatment policy; modified itt; R0002409:Table 2
30	A5	responders	64.5		53	treatment policy; modified itt; R0002409:Table 2
30	A5 vs A6	rd	60.7	47.2 to 74.1		treatment policy; modified itt; R0002409:Table 2
30	A6	responders	3.9		66	treatment policy; modified itt; R0002409:Table 2

Weight loss of 20 percent or more (11 lines; O11D)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
30	A1	responders	9.0		52	treatment policy; modified itt; R0002409:Table 2
30	A1 vs A6	rd	4.7	-5.6 to 15.0		treatment policy; modified itt; R0002409:Table 2
30	A2	responders	16.7		53	treatment policy; modified itt; R0002409:Table 2
30	A2 vs A6	rd	13.6	3.9 to 23.3		treatment policy; modified itt; R0002409:Table 2
30	A3	responders	19.4		52	treatment policy; modified itt; R0002409:Table 2
30	A3 vs A6	rd	16.7	4.7 to 28.8		treatment policy; modified itt; R0002409:Table 2
30	A4	responders	39.2		64	treatment policy; modified itt; R0002409:Table 2
30	A4 vs A6	rd	37.3	23.9 to 50.6		treatment policy; modified itt; R0002409:Table 2
30	A5	responders	37.3		53	treatment policy; modified itt; R0002409:Table 2
30	A5 vs A6	rd	34.3	20.1 to 48.4		treatment policy; modified itt; R0002409:Table 2
30	A6	responders	3.5		66	treatment policy; modified itt; R0002409:Table 2

All cause mortality (6 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 52	not stated; safety; R0002409:Table 3
A2	events	0 / 53	not stated; safety; R0002409:Table 3
A3	events	0 / 52	not stated; safety; R0002409:Table 3
A4	events	0 / 64	not stated; safety; R0002409:Table 3
A5	events	0 / 53	not stated; safety; R0002409:Table 3
A6	events	0 / 66	not stated; safety; R0002409:Table 3

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A4	events				0 / 64	not stated; safety; R0002409:Table 3

SF-36 physical component summary change (11 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	2.99 points	0.57		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A1 vs A6	md	1.32 points		-0.18 to 2.82		treatment policy; modified itt; R0002409:Supplement Table S5
30	A2	change	3.77 points	0.544		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A2 vs A6	md	2.10 points		0.65 to 3.55		treatment policy; modified itt; R0002409:Supplement Table S5
30	A3	change	3.23 points	0.55		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A3 vs A6	md	1.56 points		0.10 to 3.02		treatment policy; modified itt; R0002409:Supplement Table S5
30	A4	change	2.73 points	0.54		64	treatment policy; modified itt; R0002409:Supplement Table S5
30	A4 vs A6	md	1.06 points		-0.40 to 2.52		treatment policy; modified itt; R0002409:Supplement Table S5
30	A5	change	1.93 points	0.57		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A5 vs A6	md	0.26 points		-1.24 to 1.77		treatment policy; modified itt; R0002409:Supplement Table S5
30	A6	change	1.67 points	0.50		66	treatment policy; modified itt; R0002409:Supplement Table S5

Physical functioning (any instrument) (22 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	8.8 points	1.68		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A1	change	2.36 points	0.56		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A1 vs A6	md	2.3 points		-2.0 to 6.6		treatment policy; modified itt; R0002409:Supplement Table S5
30	A1 vs A6	md	1.35 points		-0.13 to 2.83		treatment policy; modified itt; R0002409:Supplement Table S5
30	A2	change	11.4 points	1.54		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A2	change	3.08 points	0.53		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A2 vs A6	md	4.9 points		0.8 to 8.9		treatment policy; modified itt; R0002409:Supplement Table S5
30	A2 vs A6	md	2.07 points		0.66 to 3.47		treatment policy; modified itt; R0002409:Supplement Table S5
30	A3	change	11.4 points	1.55		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A3	change	3.17 points	0.53		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A3 vs A6	md	4.9 points		0.8 to 9.0		treatment policy; modified itt; R0002409:Supplement Table S5
30	A3 vs A6	md	2.16 points		0.74 to 3.58		treatment policy; modified itt; R0002409:Supplement Table S5
30	A4	change	8.9 points	1.78		64	treatment policy; modified itt; R0002409:Supplement Table S5
30	A4	change	2.92 points	0.55		64	treatment policy; modified itt; R0002409:Supplement Table S5
30	A4 vs A6	md	2.4 points		-2.1 to 6.8		treatment policy; modified itt; R0002409:Supplement Table S5
30	A4 vs A6	md	1.91 points		0.44 to 3.38		treatment policy; modified itt; R0002409:Supplement Table S5
30	A5	change	7.5 points	1.62		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A5	change	1.86 points	0.54		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A5 vs A6	md	1.0 points		-3.2 to 5.1		treatment policy; modified itt; R0002409:Supplement Table S5
30	A5 vs A6	md	0.86 points		-0.61 to 2.32		treatment policy; modified itt; R0002409:Supplement Table S5
30	A6	change	6.6 points	1.39		66	treatment policy; modified itt; R0002409:Supplement Table S5
30	A6	change	1.01 points	0.49		66	treatment policy; modified itt; R0002409:Supplement Table S5

Health related quality of life total score (any instrument) (11 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
30	A1	change	10.61 points	1.65		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A1 vs A6	md	2.58 points		-1.63 to 6.78		treatment policy; modified itt; R0002409:Supplement Table S5
30	A2	change	12.57 points	1.52		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A2 vs A6	md	4.53 points		0.52 to 8.54		treatment policy; modified itt; R0002409:Supplement Table S5
30	A3	change	12.68 points	1.55		52	treatment policy; modified itt; R0002409:Supplement Table S5
30	A3 vs A6	md	4.65 points		0.59 to 8.70		treatment policy; modified itt; R0002409:Supplement Table S5
30	A4	change	11.05 points	1.73		64	treatment policy; modified itt; R0002409:Supplement Table S5
30	A4 vs A6	md	3.01 points		-1.37 to 7.40		treatment policy; modified itt; R0002409:Supplement Table S5
30	A5	change	8.45 points	1.62		53	treatment policy; modified itt; R0002409:Supplement Table S5
30	A5 vs A6	md	0.42 points		-3.73 to 4.56		treatment policy; modified itt; R0002409:Supplement Table S5
30	A6	change	8.03 points	1.38		66	treatment policy; modified itt; R0002409:Supplement Table S5

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 52	not stated; safety; R0002409:Table 3
A2	events	3 / 53	not stated; safety; R0002409:Table 3
A3	events	1 / 52	not stated; safety; R0002409:Table 3
A4	events	0 / 64	not stated; safety; R0002409:Table 3
A5	events	2 / 53	not stated; safety; R0002409:Table 3
A6	events	1 / 66	not stated; safety; R0002409:Table 3

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 52	not stated; safety; R0002409:Table 3
A2	events	1 / 53	not stated; safety; R0002409:Table 3
A3	events	4 / 52	not stated; safety; R0002409:Table 3
A4	events	10 / 64	not stated; safety; R0002409:Table 3
A5	events	5 / 53	not stated; safety; R0002409:Table 3
A6	events	3 / 66	not stated; safety; R0002409:Table 3

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	18 / 52	not stated; safety; R0002409:Table 3
A2	events	25 / 53	not stated; safety; R0002409:Table 3
A3	events	25 / 52	not stated; safety; R0002409:Table 3
A4	events	41 / 64	not stated; safety; R0002409:Table 3
A5	events	20 / 53	not stated; safety; R0002409:Table 3
A6	events	6 / 66	not stated; safety; R0002409:Table 3

Vomiting (6 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	13 / 52	not stated; safety; R0002409:Table 3
A2	events	15 / 53	not stated; safety; R0002409:Table 3
A3	events	24 / 52	not stated; safety; R0002409:Table 3
A4	events	40 / 64	not stated; safety; R0002409:Table 3
A5	events	28 / 53	not stated; safety; R0002409:Table 3
A6	events	8 / 66	not stated; safety; R0002409:Table 3

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	14 / 52	not stated; safety; R0002409:Table 3
A2	events	19 / 53	not stated; safety; R0002409:Table 3
A3	events	22 / 52	not stated; safety; R0002409:Table 3
A4	events	24 / 64	not stated; safety; R0002409:Table 3
A5	events	26 / 53	not stated; safety; R0002409:Table 3
A6	events	12 / 66	not stated; safety; R0002409:Table 3

Acute pancreatitis (6 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 52	not stated; safety; pancreatitis; R0002409:Results
A2	events	0 / 53	not stated; safety; pancreatitis; R0002409:Results
A3	events	0 / 52	not stated; safety; pancreatitis; R0002409:Results
A4	events	0 / 64	not stated; safety; pancreatitis; R0002409:Results
A5	events	0 / 53	not stated; safety; pancreatitis; R0002409:Results
A6	events	0 / 66	not stated; safety; pancreatitis; R0002409:Results

Suicidal ideation or behavior (6 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 52	not stated; safety; R0002409:Results
A2	events	0 / 53	not stated; safety; R0002409:Results
A3	events	0 / 52	not stated; safety; R0002409:Results
A4	events	0 / 64	not stated; safety; R0002409:Results
A5	events	0 / 53	not stated; safety; R0002409:Results
A6	events	0 / 66	not stated; safety; R0002409:Results

Death by suicide (6 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 52	not stated; safety; R0002409:Table 3
A2	events	0 / 53	not stated; safety; R0002409:Table 3
A3	events	0 / 52	not stated; safety; R0002409:Table 3
A4	events	0 / 64	not stated; safety; R0002409:Table 3
A5	events	0 / 53	not stated; safety; R0002409:Table 3
A6	events	0 / 66	not stated; safety; R0002409:Table 3