parallel randomized trial

NCT04904913

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects

Overweight or obesity without diabetes (adults)NCT04904913S001183

Design

Randomized: 248
Start year: 2021
Treatment: 24 weeks, follow-up 36 weeks
Countries: China (19 sites)
Sponsor: Innovent Biologics (industry)
Eligibility: Chinese adults 18 to 75; BMI 28 or more, or 24 or more with comorbidity or hyperphagia; no diabetes, HbA1c below 6.5

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Mazdutide 3 mg subcutaneous once weekly Mazdutide 3 mg	lifestyle: none	62	62	55
A2	Mazdutide 4.5 mg subcutaneous once weekly Mazdutide 4.5 mg	lifestyle: none	63	63	59
A3	Mazdutide 6 mg subcutaneous once weekly Mazdutide 6 mg	lifestyle: none	61	61	53
A4	Placebo Placebo	lifestyle: none	62	62	57

Baseline characteristics

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

Characteristic	Statistic	Mazdutide 3 mg subcutaneous once weekly A1	Mazdutide 4.5 mg subcutaneous once weekly A2	Mazdutide 6 mg subcutaneous once weekly A3	Placebo A4
age	mean (years)	37.2	33.6	35.8	35.5
age	sd (years)	10.7	10.0	9.2	7.1
asian	n	62	63	61	62
asian	percent	100	100	100	100
bmi	mean (kg/m2)	31.8	31.8	31.7	32.0
bmi	sd (kg/m2)	3.9	4.7	4.0	4.2
female	n	35	37	27	30
female	percent	56.5	58.7	44.3	48.4
hba1c	mean (percent)	5.41	5.40	5.34	5.45
hba1c	sd (percent)	0.27	0.32	0.35	0.35
sbp	mean (mmHg)	119.2	116.3	120.8	118.5
sbp	sd (mmHg)	12.0	11.4	9.6	12.3
waist	mean (cm)	104.1	104.7	103.9	106.0
waist	sd (cm)	8.6	11.3	11.4	12.0
weight	mean (kg)	89.8	89.3	88.5	90.2
weight	sd (kg)	14.4	15.3	15.3	16.4

Analyses this trial contributes to

Results

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

Systolic blood pressure change (14 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.3 mmHg	1.3		62	not stated; modified itt; R0016107:Table 3
24	A1 vs A4	md	-4.2 mmHg		-7.5 to -0.9		not stated; modified itt; R0016107:Table 3
24	A2	change	-2.2 mmHg	1.2		63	not stated; modified itt; R0016107:Table 3
24	A2 vs A4	md	-5.2 mmHg		-8.4 to -1.9		not stated; modified itt; R0016107:Table 3
24	A3	change	-6.9 mmHg	1.2		61	not stated; modified itt; R0016107:Table 3
24	A3 vs A4	md	-9.9 mmHg		-13.2 to -6.6		not stated; modified itt; R0016107:Table 3
24	A4	change	2.9 mmHg	1.2		62	not stated; modified itt; R0016107:Table 3
36	A1	change	1.1 mmHg	1.2		62	not stated; modified itt; R0016107:Supplement Table S3
36	A1 vs A4	md	-0.7 mmHg		-3.8 to 2.5		not stated; modified itt; R0016107:Supplement Table S3
36	A2	change	-0.5 mmHg	1.2		63	not stated; modified itt; R0016107:Supplement Table S3
36	A2 vs A4	md	-2.2 mmHg		-5.3 to 0.9		not stated; modified itt; R0016107:Supplement Table S3
36	A3	change	-4.4 mmHg	1.2		61	not stated; modified itt; R0016107:Supplement Table S3
36	A3 vs A4	md	-6.2 mmHg		-9.4 to -3.0		not stated; modified itt; R0016107:Supplement Table S3
36	A4	change	1.8 mmHg	1.2		62	not stated; modified itt; R0016107:Supplement Table S3

Percent body weight change (28 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	percent change	-6.7 percent	0.7		62	not stated; modified itt; R0016107:Table 2
24	A1	percent change	-7.2 percent	0.8		62	not stated; modified itt; R0016107:Supplement Table S1
24	A1	percent change	-7.2 percent	0.7		62	not stated; modified itt; R0016107:Supplement Table S1
24	A1 vs A4	md	-7.7 percent		-9.5 to -5.9		not stated; modified itt; R0016107:Table 2
24	A1 vs A4	md	-8.3 percent		-10.1 to -6.4		not stated; modified itt; R0016107:Supplement Table S1
24	A1 vs A4	md	-8.3 percent		-10.1 to -6.4		not stated; modified itt; R0016107:Supplement Table S1
24	A2	percent change	-10.4 percent	0.7		63	not stated; modified itt; R0016107:Table 2
24	A2	percent change	-10.5 percent	0.7		63	not stated; modified itt; R0016107:Supplement Table S1
24	A2	percent change	-10.6 percent	0.7		63	not stated; modified itt; R0016107:Supplement Table S1
24	A2 vs A4	md	-11.4 percent		-13.2 to -9.6		not stated; modified itt; R0016107:Table 2
24	A2 vs A4	md	-11.6 percent		-13.4 to -9.8		not stated; modified itt; R0016107:Supplement Table S1
24	A2 vs A4	md	-11.6 percent		-13.4 to -9.8		not stated; modified itt; R0016107:Supplement Table S1
24	A3	percent change	-11.3 percent	0.7		61	not stated; modified itt; R0016107:Table 2
24	A3	percent change	-11.6 percent	0.7		61	not stated; modified itt; R0016107:Supplement Table S1
24	A3	percent change	-11.6 percent	0.7		61	not stated; modified itt; R0016107:Supplement Table S1
24	A3 vs A4	md	-12.3 percent		-14.1 to -10.5		not stated; modified itt; R0016107:Table 2
24	A3 vs A4	md	-12.6 percent		-14.5 to -10.8		not stated; modified itt; R0016107:Supplement Table S1
24	A3 vs A4	md	-12.6 percent		-14.5 to -10.8		not stated; modified itt; R0016107:Supplement Table S1
24	A4	percent change	1.0 percent	0.7		62	not stated; modified itt; R0016107:Table 2
24	A4	percent change	1.1 percent	0.8		62	not stated; modified itt; R0016107:Supplement Table S1
24	A4	percent change	1.0 percent	0.7		62	not stated; modified itt; R0016107:Supplement Table S1
36	A1	percent change	-5.2 percent	0.7		62	not stated; modified itt; R0016107:Supplement Table S3
36	A1 vs A4	md	-6.0 percent		-8.0 to -4.0		not stated; modified itt; R0016107:Supplement Table S3
36	A2	percent change	-7.2 percent	0.7		63	not stated; modified itt; R0016107:Supplement Table S3
36	A2 vs A4	md	-8.0 percent		-10.0 to -6.0		not stated; modified itt; R0016107:Supplement Table S3
36	A3	percent change	-8.1 percent	0.7		61	not stated; modified itt; R0016107:Supplement Table S3
36	A3 vs A4	md	-9.0 percent		-11.0 to -7.0		not stated; modified itt; R0016107:Supplement Table S3
36	A4	percent change	0.8 percent	0.7		62	not stated; modified itt; R0016107:Supplement Table S3

Weight loss of 5 percent or more (7 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	responders			36 / 62	not stated; modified itt; R0016107:Table 2
24	A1 vs A4	rd	53.2	39.9 to 66.5		not stated; modified itt; R0016107:Table 2
24	A2	responders			52 / 63	not stated; modified itt; R0016107:Table 2
24	A2 vs A4	rd	77.3	66.4 to 88.1		not stated; modified itt; R0016107:Table 2
24	A3	responders			49 / 61	not stated; modified itt; R0016107:Table 2
24	A3 vs A4	rd	75.1	63.7 to 86.5		not stated; modified itt; R0016107:Table 2
24	A4	responders			3 / 62	not stated; modified itt; R0016107:Table 2

Weight loss of 10 percent or more (7 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	responders			12 / 62	not stated; modified itt; R0016107:Table 2
24	A1 vs A4	rd	19.4	9.5 to 29.2		not stated; modified itt; R0016107:Table 2
24	A2	responders			31 / 63	not stated; modified itt; R0016107:Table 2
24	A2 vs A4	rd	48.9	36.5 to 61.3		not stated; modified itt; R0016107:Table 2
24	A3	responders			31 / 61	not stated; modified itt; R0016107:Table 2
24	A3 vs A4	rd	50.1	37.5 to 62.8		not stated; modified itt; R0016107:Table 2
24	A4	responders			0 / 62	not stated; modified itt; R0016107:Table 2

Weight loss of 15 percent or more (7 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	responders			6 / 62	not stated; modified itt; R0016107:Table 2
24	A1 vs A4	rd	9.7	2.3 to 17.0		not stated; modified itt; R0016107:Table 2
24	A2	responders			10 / 63	not stated; modified itt; R0016107:Table 2
24	A2 vs A4	rd	15.7	6.7 to 24.6		not stated; modified itt; R0016107:Table 2
24	A3	responders			16 / 61	not stated; modified itt; R0016107:Table 2
24	A3 vs A4	rd	25.4	14.4 to 36.4		not stated; modified itt; R0016107:Table 2
24	A4	responders			0 / 62	not stated; modified itt; R0016107:Table 2

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 62	not stated; safety; R0016107:Table 4
A2	events	4 / 63	not stated; safety; R0016107:Table 4
A3	events	4 / 61	not stated; safety; R0016107:Table 4
A4	events	0 / 62	not stated; safety; R0016107:Table 4

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0016107:Table 4
A2	events	1 / 63	not stated; safety; R0016107:Table 4
A3	events	0 / 61	not stated; safety; R0016107:Table 4
A4	events	0 / 62	not stated; safety; R0016107:Table 4

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	13 / 62	not stated; safety; R0016107:Table 4
A2	events	15 / 63	not stated; safety; R0016107:Table 4
A3	events	25 / 61	not stated; safety; R0016107:Table 4
A4	events	3 / 62	not stated; safety; R0016107:Table 4

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	8 / 62	not stated; safety; R0016107:Table 4
A2	events	13 / 63	not stated; safety; R0016107:Table 4
A3	events	17 / 61	not stated; safety; R0016107:Table 4
A4	events	2 / 62	not stated; safety; R0016107:Table 4

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	12 / 62	not stated; safety; R0016107:Table 4
A2	events	19 / 63	not stated; safety; R0016107:Table 4
A3	events	19 / 61	not stated; safety; R0016107:Table 4
A4	events	9 / 62	not stated; safety; R0016107:Table 4

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0016107:Results
A2	events	0 / 63	not stated; safety; R0016107:Results
A3	events	0 / 61	not stated; safety; R0016107:Results
A4	events	0 / 62	not stated; safety; R0016107:Results

Medullary thyroid carcinoma (4 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0016107:Results
A2	events	0 / 63	not stated; safety; R0016107:Results
A3	events	0 / 61	not stated; safety; R0016107:Results
A4	events	0 / 62	not stated; safety; R0016107:Results

Thyroid cancer (any) (4 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0016107:Results
A2	events	0 / 63	not stated; safety; R0016107:Results
A3	events	0 / 61	not stated; safety; R0016107:Results
A4	events	0 / 62	not stated; safety; R0016107:Results

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0016107:Results
A2	events	0 / 63	not stated; safety; R0016107:Results
A3	events	0 / 61	not stated; safety; R0016107:Results
A4	events	0 / 62	not stated; safety; R0016107:Results

Any cancer (4 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 62	not stated; safety; R0016107:Results
A2	events	0 / 63	not stated; safety; R0016107:Results
A3	events	0 / 61	not stated; safety; R0016107:Results
A4	events	0 / 62	not stated; safety; R0016107:Results