每周一次皮下注射司美格鲁肽对日本超重和肥胖成年人腹部内脏脂肪面积的影响：STEP 6试验的事后分析

Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial.

作者信息

Kadowaki Takashi, Nishida Tomoyuki, Ogawa Wataru, Overvad Maria, Tobe Kazuyuki, Yamauchi Toshimasa

机构信息

Toranomon Hospital, 2 Chome-2-2 Toranomon, Minato City, Tokyo 105-8470, Japan.

Novo Nordisk Pharma Ltd., 2 Chome-1-1 Marunouchi, Chiyoda City, Tokyo 100-0005, Japan.

出版信息

Obes Res Clin Pract. 2025 Mar-Apr;19(2):146-153. doi: 10.1016/j.orcp.2025.03.003. Epub 2025 Apr 4.

DOI:10.1016/j.orcp.2025.03.003

PMID:40189961

Abstract

OBJECTIVE

A post hoc analysis of a subset of participants with visceral fat area (VFA) measurements in the STEP 6 trial was conducted to examine both the correlation between VFA and clinical parameters and the effect of semaglutide on VFA in key subgroups.

METHODS

Participants were Japanese adults aged ≥ 20 years with obesity disease, randomized to once-weekly subcutaneous semaglutide 2.4 mg, semaglutide 1.7 mg, or placebo, plus lifestyle recommendations, for 68 weeks. Correlation between baseline VFA (and change in VFA from baseline to week 68) and clinical parameters (body weight, body mass index [BMI], waist circumference, hepatic parameters, glycated hemoglobin, blood pressure, lipids, high-sensitivity C-reactive protein, and plasminogen activator inhibitor-1 [PAI-1]) was evaluated. Percentage change in VFA between semaglutide and placebo was compared across subgroups.

RESULTS

Among 180 participants (semaglutide 2.4 mg, n = 89; semaglutide 1.7 mg, n = 46; placebo, n = 45), mean VFA was 170.0 cm across subgroups. A positive correlation (Pearson's correlation coefficient [r] ≥0.3) was observed between baseline VFA and body weight (r = 0.415), BMI (r = 0.374), and both JASSO and WHO criterion waist circumference (r = 0.458 and r = 0.555). Correlation between changes in VFA and body weight, waist circumference, high-density and very low-density lipoprotein cholesterol, triglycerides, PAI-1, aspartate aminotransferase, and alanine transaminase were observed in ≥ 1 treatment arm. Semaglutide 2.4 mg and 1.7 mg reduced VFA compared with placebo in all subgroups.

CONCLUSIONS

VFA partially correlated with clinical parameters in Japanese adults with obesity disease. Subcutaneous semaglutide was an efficacious treatment option for the reduction of VFA, regardless of clinical characteristics.

TRIAL REGISTRY NAME

CT.gov TRIAL REGISTRATION IDENTIFICATION NUMBER: NCT03811574.

摘要

目的

对STEP 6试验中一部分有内脏脂肪面积（VFA）测量值的参与者进行事后分析，以研究VFA与临床参数之间的相关性以及司美格鲁肽对关键亚组中VFA的影响。

方法

参与者为年龄≥20岁的日本肥胖症成年人，随机分为每周一次皮下注射2.4mg司美格鲁肽、1.7mg司美格鲁肽或安慰剂，并给予生活方式建议，为期68周。评估基线VFA（以及从基线到第68周VFA的变化）与临床参数（体重、体重指数[BMI]、腰围、肝脏参数、糖化血红蛋白、血压、血脂、高敏C反应蛋白和纤溶酶原激活物抑制剂-1[PAI-1]）之间的相关性。比较司美格鲁肽组和安慰剂组之间各亚组VFA的百分比变化。

结果

在180名参与者中（2.4mg司美格鲁肽组，n = 89；1.7mg司美格鲁肽组，n = 46；安慰剂组，n = 45），各亚组的平均VFA为170.0cm²。观察到基线VFA与体重（r = 0.415）、BMI（r = 0.374）以及日本厚生劳动省和世界卫生组织标准腰围（r = 0.458和r = 0.555）之间呈正相关（Pearson相关系数[r]≥0.3）。在≥1个治疗组中观察到VFA变化与体重、腰围、高密度和极低密度脂蛋白胆固醇、甘油三酯、PAI-1、天冬氨酸转氨酶和丙氨酸转氨酶之间的相关性。与安慰剂相比，2.4mg和1.7mg司美格鲁肽在所有亚组中均降低了VFA。