parallel randomized trial

NCT06569355

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VCT220 Tablets in Overweight/Obese Subjects

Overweight or obesity without diabetes (adults)NCT06569355S002553

Design

Randomized: 250
Start year: 2023
Treatment: 16 weeks, follow-up 18 weeks
Countries: China (13 sites)
Sponsor: Chengdu Vincentage Pharma Co., Ltd. (industry)
Eligibility: age 18 to 75; BMI 28 or more, or 24 to 28 with comorbidity; no diabetes

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, missing at random

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	VCT220 80 mg tablet once daily VCT220 80 mg	lifestyle: standard	65	65	63
A2	VCT220 120 mg tablet once daily VCT220 120 mg	lifestyle: standard	62	62	58
A3	VCT220 VCT220 160 mg slow titration	lifestyle: standard	31	31	28
A4	VCT220 VCT220 160 mg fast titration	lifestyle: standard	31	31	29
A5	Placebo Placebo pooled	lifestyle: standard	61	61	59

Baseline characteristics

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

Characteristic	Statistic	VCT220 80 mg tablet once daily A1	VCT220 120 mg tablet once daily A2	VCT220 160 mg slow titration A3	VCT220 160 mg fast titration A4	Placebo A5
age	mean (years)	32.8	32.3	32.5	30.6	32.9
age	sd (years)	7.06	7.27	7.02	6.78	8.63
bmi: 24 to less than 28	n	4	5	1	3	3
bmi: 24 to less than 28	percent	6.2	8.1	3.2	9.7	4.9
bmi: 28 or more	n	61	57	30	28	58
bmi: 28 or more	percent	93.8	91.9	96.8	90.3	95.1
bmi	mean (kg/m2)	31.68	31.77	31.91	32.71	32.39
bmi	sd (kg/m2)	3.23	3.35	2.92	3.64	3.22
female	n	29	24	11	12	28
female	percent	44.6	38.7	35.5	38.7	45.9
other race han	n	63	59	30	31	60
other race han	percent	96.9	95.2	96.8	100.0	98.4
other race other	n	2	3	1	0	1
other race other	percent	3.1	4.8	3.2	0.0	1.6
sbp	mean (mmHg)	122.5	124.0	123.1	125.7	124.7
sbp	sd (mmHg)	13.58	10.40	12.26	9.21	11.05
weight	mean (kg)	90.53	91.29	90.49	95.29	92.40
weight	sd (kg)	13.09	14.62	11.49	14.73	14.37

Analyses this trial contributes to

Results

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

Systolic blood pressure change (10 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-5.2 mmHg	1.19	63	treatment policy; full analysis; R0001121:Supplement Table S4
16	A2	change	-7.2 mmHg	1.22	57	treatment policy; full analysis; R0001121:Supplement Table S4
16	A3	change	-8.9 mmHg	1.76	28	treatment policy; full analysis; R0001121:Supplement Table S4
16	A4	change	-10.4 mmHg	1.73	29	treatment policy; full analysis; R0001121:Supplement Table S4
16	A5	change	-3.1 mmHg	1.21	59	treatment policy; full analysis; R0001121:Supplement Table S4
18	A1	change	-5.5 mmHg	1.06		treatment policy; full analysis; R0001121:Supplement Table S4
18	A2	change	-7.2 mmHg	1.11		treatment policy; full analysis; R0001121:Supplement Table S4
18	A3	change	-8.9 mmHg	1.59		treatment policy; full analysis; R0001121:Supplement Table S4
18	A4	change	-7.7 mmHg	1.56		treatment policy; full analysis; R0001121:Supplement Table S4
18	A5	change	-4.3 mmHg	1.09		treatment policy; full analysis; R0001121:Supplement Table S4

Percent body weight change (50 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1 vs A5	md	-4.160 percent		-5.528 to -2.792		treatment policy; full analysis; R0001121:Supplement Table S3
16	A1	percent change	-5.75 percent		-6.71 to -4.80	65	treatment policy; full analysis; R0001121:Table 2
16	A1	percent change	-5.760 percent	0.495		65	treatment policy; full analysis; R0001121:Supplement Table S3
16	A1	percent change	-5.709 percent	0.357		63	treatment policy; full analysis; R0001121:Supplement Table S2
16	A1 vs A5	md	-4.14 percent		-5.51 to -2.77		treatment policy; full analysis; R0001121:Table 2
16	A1 vs A5	md	-4.086 percent		-5.091 to -3.082		treatment policy; full analysis; R0001121:Supplement Table S2
16	A1	percent change	-4.287 percent	1.139		4	treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A1 vs A5	md	-2.458 percent		-6.340 to 1.423		treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A1	percent change	-5.837 percent	0.517		61	treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A1 vs A5	md	-4.225 percent		-5.674 to -2.777		treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A2 vs A5	md	-5.812 percent		-7.198 to -4.425		treatment policy; full analysis; R0001121:Supplement Table S3
16	A2 vs A5	md	-5.915 percent		-6.930 to -4.899		treatment policy; full analysis; R0001121:Supplement Table S2
16	A2	percent change	-7.957 percent	1.045		5	treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A2 vs A5	md	-6.128 percent		-9.713 to -2.542		treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A2	percent change	-7.400 percent	0.542		57	treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A2 vs A5	md	-5.789 percent		-7.270 to -4.307		treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A2	percent change	-7.42 percent		-8.41 to -6.44	62	treatment policy; full analysis; R0001121:Table 2
16	A2	percent change	-7.412 percent	0.510		62	treatment policy; full analysis; R0001121:Supplement Table S3
16	A2	percent change	-7.537 percent	0.365		57	treatment policy; full analysis; R0001121:Supplement Table S2
16	A2 vs A5	md	-5.81 percent		-7.20 to -4.43		treatment policy; full analysis; R0001121:Table 2
16	A3 vs A5	md	-9.623 percent		-15.334 to -3.911		treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A3	percent change	-11.452 percent	2.267		1	treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A3 vs A5	md	-7.725 percent		-9.501 to -5.948		treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A3 vs A5	md	-8.269 percent		-9.389 to -7.148		treatment policy; full analysis; R0001121:Supplement Table S2
16	A3	percent change	-9.336 percent	0.737		30	treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A3 vs A5	md	-7.786 percent		-9.482 to -6.091		treatment policy; full analysis; R0001121:Supplement Table S3
16	A3 vs A5	md	-7.79 percent		-9.49 to -6.10		treatment policy; full analysis; R0001121:Table 2
16	A3	percent change	-9.891 percent	0.438		28	treatment policy; full analysis; R0001121:Supplement Table S2
16	A3	percent change	-9.386 percent	0.714		31	treatment policy; full analysis; R0001121:Supplement Table S3
16	A3	percent change	-9.40 percent		-10.79 to -8.02	31	treatment policy; full analysis; R0001121:Table 2
16	A4	percent change	-9.746 percent	0.732		31	treatment policy; full analysis; R0001121:Supplement Table S3
16	A4 vs A5	md	-8.11 percent		-9.85 to -6.38		treatment policy; full analysis; R0001121:Table 2
16	A4 vs A5	md	-8.146 percent		-9.874 to -6.418		treatment policy; full analysis; R0001121:Supplement Table S3
16	A4 vs A5	md	-8.022 percent		-9.136 to -6.907		treatment policy; full analysis; R0001121:Supplement Table S2
16	A4	percent change	-9.561 percent	0.794		28	treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A4	percent change	-10.719 percent	1.348		3	treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A4 vs A5	md	-8.890 percent		-13.160 to -4.620		treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
16	A4 vs A5	md	-7.949 percent		-9.816 to -6.083		treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A4	percent change	-9.73 percent		-11.16 to -8.29	31	treatment policy; full analysis; R0001121:Table 2
16	A4	percent change	-9.644 percent	0.434		29	treatment policy; full analysis; R0001121:Supplement Table S2
16	A5	percent change	-1.600 percent	0.508		61	treatment policy; full analysis; R0001121:Supplement Table S3
16	A5	percent change	-1.61 percent		-2.59 to -0.63	61	treatment policy; full analysis; R0001121:Table 2
16	A5	percent change	-1.611 percent	0.527		58	treatment policy; full analysis; bmi:28_or_more; R0001121:Supplement Table S8
16	A5	percent change	-1.623 percent	0.366		59	treatment policy; full analysis; R0001121:Supplement Table S2
16	A5	percent change	-1.829 percent	1.360		3	treatment policy; full analysis; bmi:24_to_less_than_28; R0001121:Supplement Table S9
18	A1	percent change	-5.266 percent	0.496			treatment policy; full analysis; R0001121:Supplement Table S1
18	A2	percent change	-7.195 percent	0.522			treatment policy; full analysis; R0001121:Supplement Table S1
18	A3	percent change	-8.488 percent	0.745			treatment policy; full analysis; R0001121:Supplement Table S1
18	A4	percent change	-9.260 percent	0.733			treatment policy; full analysis; R0001121:Supplement Table S1
18	A5	percent change	-1.505 percent	0.513			treatment policy; full analysis; R0001121:Supplement Table S1

Weight loss of 5 percent or more (9 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1 vs A5	rd	42.3	26.17 to 55.34		treatment policy; full analysis; R0001121:Table 2
16	A1	responders			36 / 65	treatment policy; full analysis; R0001121:Table 2
16	A2 vs A5	rd	59.5	43.27 to 70.91		treatment policy; full analysis; R0001121:Table 2
16	A2	responders			45 / 62	treatment policy; full analysis; R0001121:Table 2
16	A3	responders			28 / 31	treatment policy; full analysis; R0001121:Table 2
16	A3 vs A5	rd	77.2	58.61 to 86.15		treatment policy; full analysis; R0001121:Table 2
16	A4 vs A5	rd	64.3	44.03 to 77.15		treatment policy; full analysis; R0001121:Table 2
16	A4	responders			24 / 31	treatment policy; full analysis; R0001121:Table 2
16	A5	responders			8 / 61	treatment policy; full analysis; R0001121:Table 2

Weight loss of 10 percent or more (9 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	responders			3 / 65	treatment policy; full analysis; R0001121:Table 2
16	A1 vs A5	rd	3.0	-4.73 to 11.19		treatment policy; full analysis; R0001121:Table 2
16	A2	responders			15 / 62	treatment policy; full analysis; R0001121:Table 2
16	A2 vs A5	rd	22.6	11.14 to 34.59		treatment policy; full analysis; R0001121:Table 2
16	A3	responders			12 / 31	treatment policy; full analysis; R0001121:Table 2
16	A3 vs A5	rd	37.1	20.50 to 54.59		treatment policy; full analysis; R0001121:Table 2
16	A4 vs A5	rd	43.5	26.03 to 60.64		treatment policy; full analysis; R0001121:Table 2
16	A4	responders			14 / 31	treatment policy; full analysis; R0001121:Table 2
16	A5	responders			1 / 61	treatment policy; full analysis; R0001121:Table 2

Weight loss of 15 percent or more (8 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	responders			1 / 65	treatment policy; full analysis; R0001121:Table 2
16	A1 vs A5	rd	1.5	-4.52 to 8.21		treatment policy; full analysis; R0001121:Table 2
16	A2 vs A5	rd	3.2	-3.14 to 11.02		treatment policy; full analysis; R0001121:Table 2
16	A2	responders			2 / 62	treatment policy; full analysis; R0001121:Table 2
16	A3	responders			0 / 31	treatment policy; full analysis; R0001121:Table 2
16	A4 vs A5	rd	9.7	1.01 to 24.90		treatment policy; full analysis; R0001121:Table 2
16	A4	responders			3 / 31	treatment policy; full analysis; R0001121:Table 2
16	A5	responders			0 / 61	treatment policy; full analysis; R0001121:Table 2

Weight loss of 20 percent or more (1 lines; O11D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A4	responders	1.6				treatment policy; full analysis; R0001121:Results

All cause mortality (5 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 65	not stated; safety; R0001121:Results
A2	events	0 / 62	not stated; safety; R0001121:Results
A3	events	0 / 31	not stated; safety; R0001121:Results
A4	events	0 / 31	not stated; safety; R0001121:Results
A5	events	0 / 61	not stated; safety; R0001121:Results

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Events / N	Detail
A3	events	0 / 31	not stated; safety; R0001121:Table 3
A4	events	0 / 31	not stated; safety; R0001121:Table 3
A5	events	0 / 61	not stated; safety; R0001121:Table 3

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 65	not stated; safety; R0001121:Table 3
A2	events	1 / 62	not stated; safety; R0001121:Table 3
A3	events	0 / 31	not stated; safety; R0001121:Table 3
A4	events	0 / 31	not stated; safety; R0001121:Table 3
A5	events	0 / 61	not stated; safety; R0001121:Table 3

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 65	not stated; safety; R0001121:Table 3
A2	events	1 / 62	not stated; safety; R0001121:Table 3
A3	events	0 / 31	not stated; safety; R0001121:Table 3
A4	events	1 / 31	not stated; safety; R0001121:Table 3
A5	events	1 / 61	not stated; safety; R0001121:Table 3

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	27 / 65	not stated; safety; R0001121:Table 3
A2	events	26 / 62	not stated; safety; R0001121:Table 3
A3	events	14 / 31	not stated; safety; R0001121:Table 3
A4	events	18 / 31	not stated; safety; R0001121:Table 3
A5	events	5 / 61	not stated; safety; R0001121:Table 3

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	9 / 65	not stated; safety; R0001121:Table 3
A2	events	20 / 62	not stated; safety; R0001121:Table 3
A3	events	11 / 31	not stated; safety; R0001121:Table 3
A4	events	13 / 31	not stated; safety; R0001121:Table 3
A5	events	5 / 61	not stated; safety; R0001121:Table 3

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	12 / 65	not stated; safety; R0001121:Table 3
A2	events	11 / 62	not stated; safety; R0001121:Table 3
A3	events	5 / 31	not stated; safety; R0001121:Table 3
A4	events	9 / 31	not stated; safety; R0001121:Table 3
A5	events	5 / 61	not stated; safety; R0001121:Table 3

Death by suicide (5 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 65	not stated; safety; R0001121:Results
A2	events	0 / 62	not stated; safety; R0001121:Results
A3	events	0 / 31	not stated; safety; R0001121:Results
A4	events	0 / 31	not stated; safety; R0001121:Results
A5	events	0 / 61	not stated; safety; R0001121:Results