parallel randomized trial

VENTURE

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of VK2735 for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition

Overweight or obesity without diabetes (adults)NCT06068946S000714

Design

Randomized: 176
Start year: 2023
Treatment: 13 weeks, follow-up 19 weeks
Countries: United States (20 sites)
Sponsor: Viking Therapeutics, Inc. (industry)
Eligibility: age over 18; BMI 30 or more, or 27 or more with comorbidity; BMI 50 or less; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: standard	35	34
A2	VK2735 2.5 mg injection once weekly VK2735 2.5 mg	lifestyle: standard	35	35
A3	VK2735 5.0 mg injection once weekly VK2735 5.0 mg	lifestyle: standard	35	35
A4	VK2735 10 mg injection once weekly VK2735 10 mg	lifestyle: standard	36	35
A5	VK2735 15 mg injection once weekly VK2735 15 mg	lifestyle: standard	35	35

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	VK2735 2.5 mg injection once weekly A2	VK2735 5.0 mg injection once weekly A3	VK2735 10 mg injection once weekly A4	VK2735 15 mg injection once weekly A5
age: 65 or older	n	4	8	8	4	8
age: 65 or older	percent	11.4	22.9	22.9	11.1	22.9
age	mean (years)	47.6	49.7	51.8	47.1	51.3
age	sd (years)	16.36	13.90	14.10	13.40	15.41
asian	n	1	0	2	0	1
asian	percent	2.9		5.7		2.9
black	n	8	7	2	10	6
black	percent	22.9	20.0	5.7	27.8	17.1
bmi	mean (kg/m2)	38.88	38.03	35.86	36.62	36.63
bmi	sd (kg/m2)	6.33	5.56	4.03	4.18	5.25
female	n	29	27	23	24	27
female	percent	82.9	77.1	65.7	66.7	77.1
hba1c	mean (percent)	5.49	5.51	5.43	5.50	5.50
hba1c	sd (percent)	0.361	0.360	0.399	0.357	0.312
hispanic	n	7	5	7	6	5
hispanic	percent	20.0	14.3	20.0	16.7	14.3
sbp	mean (mmHg)	125.10	126.20	128.60	122.64	123.36
sbp	sd (mmHg)	13.963	14.754	15.253	13.764	14.531
weight	mean (kg)	104.48	103.09	98.32	102.98	101.05
weight	sd (kg)	22.18	19.01	13.18	18.27	18.91
white	n	26	28	31	26	28
white	percent	74.3	80.0	88.6	72.2	80.0

Analyses this trial contributes to

Results

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

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Detail
13	A1	change	-4.20 mmHg	1.993	not stated; randomized; R0011224:Table 5
13	A2	change	-6.87 mmHg	1.906	not stated; randomized; R0011224:Table 5
13	A3	change	-6.71 mmHg	1.931	not stated; randomized; R0011224:Table 5
13	A4	change	-7.04 mmHg	1.936	not stated; randomized; R0011224:Table 5
13	A5	change	-10.97 mmHg	2.000	not stated; randomized; R0011224:Table 5

Percent body weight change (9 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
13	A1	percent change	-1.7 percent	-3.03 to -0.30	34	hypothetical; modified itt; R0011224:Table 2
13	A2 vs A1	md	-7.43 percent	-9.34 to -5.52		hypothetical; modified itt; R0011224:Table 2
13	A2	percent change	-9.1 percent	-10.43 to -7.76	35	hypothetical; modified itt; R0011224:Table 2
13	A3 vs A1	md	-9.23 percent	-11.15 to -7.31		hypothetical; modified itt; R0011224:Table 2
13	A3	percent change	-10.9 percent	-12.25 to -9.55	35	hypothetical; modified itt; R0011224:Table 2
13	A4	percent change	-12.9 percent	-14.30 to -11.56	35	hypothetical; modified itt; R0011224:Table 2
13	A4 vs A1	md	-11.26 percent	-13.20 to -9.33		hypothetical; modified itt; R0011224:Table 2
13	A5	percent change	-14.7 percent	-16.11 to -13.38	35	hypothetical; modified itt; R0011224:Table 2
13	A5 vs A1	md	-13.08 percent	-15.01 to -11.15		hypothetical; modified itt; R0011224:Table 2

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
13	A1	responders			4 / 34	not stated; modified itt; R0011224:Table 2
13	A2 vs A1	or	26.7	6.9 to 103.2		not stated; modified itt; R0011224:Table 2
13	A2	responders			28 / 35	not stated; modified itt; R0011224:Table 2
13	A3	responders			34 / 35	not stated; modified itt; R0011224:Table 2
13	A3 vs A1	or	148.9			not stated; modified itt; R0011224:Table 2
13	A4 vs A1	or	84.6	15.6 to 457.2		not stated; modified itt; R0011224:Table 2
13	A4	responders			33 / 35	not stated; modified itt; R0011224:Table 2
13	A5	responders			35 / 35	not stated; modified itt; R0011224:Table 2
13	A5 vs A1	or	454.1			not stated; modified itt; R0011224:Table 2

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
13	A1	responders			1 / 34	not stated; modified itt; R0011224:Table 2
13	A2	responders			14 / 35	not stated; modified itt; R0011224:Table 2
13	A2 vs A1	or	23.6	2.8 to 197.5		not stated; modified itt; R0011224:Table 2
13	A3 vs A1	or	60.2	7.1 to 509.3		not stated; modified itt; R0011224:Table 2
13	A3	responders			23 / 35	not stated; modified itt; R0011224:Table 2
13	A4	responders			25 / 35	not stated; modified itt; R0011224:Table 2
13	A4 vs A1	or	91.5	10.4 to 806.8		not stated; modified itt; R0011224:Table 2
13	A5 vs A1	or	315.5			not stated; modified itt; R0011224:Table 2
13	A5	responders			31 / 35	not stated; modified itt; R0011224:Table 2

Weight loss of 15 percent or more (9 lines; O11C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
13	A1	responders			0 / 34	not stated; modified itt; R0011224:Table 2
13	A2	responders			4 / 35	not stated; modified itt; R0011224:Table 2
13	A2 vs A1	or	11.2	0.5 to 228.2		not stated; modified itt; R0011224:Table 2
13	A3	responders			4 / 35	not stated; modified itt; R0011224:Table 2
13	A3 vs A1	or	9.1	0.4 to 188.6		not stated; modified itt; R0011224:Table 2
13	A4 vs A1	or	35.9	1.9 to 677.1		not stated; modified itt; R0011224:Table 2
13	A4	responders			11 / 35	not stated; modified itt; R0011224:Table 2
13	A5 vs A1	or	52.3	2.8 to 982.7		not stated; modified itt; R0011224:Table 2
13	A5	responders			15 / 35	not stated; modified itt; R0011224:Table 2

All cause mortality (5 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; R0011224:Table 3
A2	events	0 / 35	not stated; safety; R0011224:Table 3
A3	events	0 / 35	not stated; safety; R0011224:Table 3
A4	events	0 / 35	not stated; safety; R0011224:Table 3
A5	events	1 / 35	not stated; safety; R0011224:Table 3

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 35	not stated; safety; R0011224:Table 3
A2	events	2 / 35	not stated; safety; R0011224:Table 3
A3	events	2 / 35	not stated; safety; R0011224:Table 3
A4	events	2 / 35	not stated; safety; R0011224:Table 3
A5	events	1 / 35	not stated; safety; R0011224:Table 3

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; R0011224:Table 3
A1	events	0 / 35	not stated; safety; R0011224:Table 3
A2	events	1 / 35	not stated; safety; R0011224:Table 3
A2	events	0 / 35	not stated; safety; R0011224:Table 3
A3	events	4 / 35	not stated; safety; R0011224:Table 3
A3	events	1 / 35	not stated; safety; R0011224:Table 3
A4	events	4 / 35	not stated; safety; R0011224:Table 3
A4	events	1 / 35	not stated; safety; R0011224:Table 3
A5	events	7 / 35	not stated; safety; R0011224:Table 3
A5	events	1 / 35	not stated; safety; R0011224:Table 3

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	7 / 35	not stated; safety; R0011224:Table 3
A2	events	9 / 35	not stated; safety; R0011224:Table 3
A3	events	16 / 35	not stated; safety; R0011224:Table 3
A4	events	13 / 35	not stated; safety; R0011224:Table 3
A5	events	22 / 35	not stated; safety; R0011224:Table 3

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; R0011224:Table 3
A2	events	3 / 35	not stated; safety; R0011224:Table 3
A3	events	6 / 35	not stated; safety; R0011224:Table 3
A4	events	6 / 35	not stated; safety; R0011224:Table 3
A5	events	10 / 35	not stated; safety; R0011224:Table 3

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	3 / 35	not stated; safety; R0011224:Table 3
A2	events	11 / 35	not stated; safety; R0011224:Table 3
A3	events	6 / 35	not stated; safety; R0011224:Table 3
A4	events	7 / 35	not stated; safety; R0011224:Table 3
A5	events	4 / 35	not stated; safety; R0011224:Table 3

Constipation (5 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	4 / 35	not stated; safety; R0011224:Table 3
A2	events	7 / 35	not stated; safety; R0011224:Table 3
A3	events	10 / 35	not stated; safety; R0011224:Table 3
A4	events	9 / 35	not stated; safety; R0011224:Table 3
A5	events	10 / 35	not stated; safety; R0011224:Table 3

Gallbladder and biliary disease (5 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; R0011224:Table 3
A2	events	1 / 35	not stated; safety; R0011224:Table 3
A3	events	0 / 35	not stated; safety; R0011224:Table 3
A4	events	0 / 35	not stated; safety; R0011224:Table 3
A5	events	1 / 35	not stated; safety; R0011224:Table 3

Acute pancreatitis (5 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 35	not stated; safety; R0011224:Table 3
A2	events	0 / 35	not stated; safety; R0011224:Table 3
A3	events	0 / 35	not stated; safety; R0011224:Table 3
A4	events	0 / 35	not stated; safety; R0011224:Table 3
A5	events	0 / 35	not stated; safety; R0011224:Table 3