来源：Viking Therapeutics 265
2024年2月27日Viking Therapeutics在线公布了其GLP-1/GIP双受体激动剂VK2735治疗肥胖症或超重2期临床试验VENTURE的试验结果。
VK2735是肽类GLP-1/GIP双受体激动剂。GIP（葡萄糖依赖性促胰岛素多肽）和GLP-1（胰高血糖素样肽-1）都属于肠促胰岛素（Incretin），能够葡萄糖浓度依赖性促进胰岛素分泌。GLP-1还能够抑制胃和胰腺消化液的分泌以及胃的蠕动排空，减少食欲，降低体重。同时激动GIP受体能够增强激动GLP-1受体后产生的治疗作用。
VENTURE试验是一项2期随机、双盲、安慰剂对照组临床试验。共入组176名BMI≥30kg/m2的肥胖患者或BMI≥27并至少伴有一项并发症的超重患者。分VK2735（2.5mg、5mg、10mg、15mg）4个剂量组和安慰剂对照组，治疗13周。
与基线相比VK2735的15mg剂量组13周的减重幅度达到14.7%，与安慰剂组相比相对减少13.1%（p<0.0001），其中88%的患者减重幅度大于10%（p<0.0001）。
| Dose Level1,2 |
Placebo
(n=34)
|
VK2735
2.5 mg
(n=35)
|
VK2735
5 mg
(n=35)
|
VK2735
10 mg
(n=35)
|
VK2735
15 mg
(n=35)
|
| Mean baseline body weight (kg)3 | 105.3 kg | 103.1 kg | 98.3 kg | 103.4 kg | 101.1 kg |
| Mean change from baseline body weight4,5 | -1.8 kg | -9.2 kg | -10.7 kg | -13.3 kg | -14.6 kg |
| Mean percent change from baseline4,5 | -1.7 % | -9.1 % | -10.9 % | -12.9 % | -14.7 % |
| Placebo-adjusted mean percent change from baseline4,5 | - | -7.4 % | -9.2 % | -11.3 % | -13.1 % |
| p-value vs. placebo5 | - | < 0.0001 | < 0.0001 | < 0.0001 | < 0.0001 |
| Percent reporting ≥ 10% weight loss | 4 % | 39 % | 62 % | 70 % | 88 % |
| p-value vs. placebo6 | - | 0.0036 | 0.0002 | < 0.0001 | < 0.0001 |
| Notes: 1) Efficacy population, includes all randomized patients who received at least one dose of study drug and had a valid baseline and post-baseline body weight assessment. 2) Patients treated with VK2735 were titrated to final doses as indicated: 2.5 mg cohort = 2.5 x 13 weeks; 5 mg cohort = 2.5 mg x 3 wks, 5 mg x 10 wks; 10 mg cohort = 2.5 mg x 3 wks, 5 mg x 3 wks, 7.5 mg x 3 wks, 10 mg x 4 wks; 15 mg cohort = 5 mg x 3 wks, 7.5 mg x 3 wks, 10 mg x 3 wks, 15 mg x 4 wks. 3) All enrolled patients were required to have baseline BMI ≥30 kg/m2 or BMI≥27 kg/m2 with at least one weight-related comorbid condition. 4) Least squares mean. 5) Two-sided t test using mixed model for repeated measures. 6) Logistic regression model with treatment as factor and baseline weight as covariate. | |||||
试验显示 VK2735的安全性良好，在研究中出现的最常见的不良事应为轻到中度，主要为胃肠道反应。
|
Placebo
(n=34)
|
VK2735
2.5 mg
(n=35)
|
VK2735
5 mg
(n=35)
|
VK2735
10 mg
(n=35)
|
VK2735
15 mg
(n=35)
|
VK2735
Combined
(n=140)
|
|
| Discontinued treatment early | 5 (14 %) | 2 (6 %) | 4 (11 %) | 5 (14 %) | 7 (20 %) | 18 (13 %) |
| Discontinued study early | 2 (6 %) | 0 (0 %) | 1 (3 %) | 2 (6 %) | 2 (6 %) | 5 (4 %) |
| Common AEs, # of Subjects reporting, (%) |
|
|
|
|
|
|
| Nausea |
|
|
|
|
|
|
| Mild | 7 (20%) | 6 (17%) | 11 (31%) | 9 (26%) | 15 (43%) | 41 (29%) |
| Moderate | 0 (0%) | 3 (9%) | 5 (14%) | 4 (11%) | 7 (20%) | 19 (14%) |
| Severe | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vomiting | 0 (0 %) | 3 (9 %) | 6 (17 %) | 6 (17 %) | 10 (29 %) | 25 (18 %) |
| Diarrhea | 3 (9 %) | 11 (31 %) | 6 (17 %) | 7 (20 %) | 4 (11 %) | 28 (20 %) |
| Constipation | 4 (11 %) | 7 (20 %) | 10 (29 %) | 9 (26 %) | 10 (29 %) | 36 (26 %) |
| Decreased appetite | 0 (0 %) | 2 (6 %) | 5 (14 %) | 9 (26 %) | 6 (17 %) | 22 (16 %) |
| Notes: Safety population, includes all randomized subjects who received at least one dose of study drug. | ||||||
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