PFCBT Dataset in Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents with Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study

Data from PFCBT Form
Study Description
This trial was an open-label Phase II non-randomized pilot study conducted at the NIH Clinical Center to investigate the efficacy of daily subcutaneous injection of liraglutide, a glucagon-like peptide-1 (GLP1) analogue to promote reduction of body mass index in adolescents who continued to have obesity 1 year or more after vertical sleeve gastrectomy (SG). We hypothesized that administration of liraglutide would be associated with reduction in BMI. Primary objective was: To determine the effect size for the change in BMI of liraglutide 3.0 mg at 16 weeks. Secondary objectives were: 1. To study the effects of liraglutide on change in mean BMI and fat mass. 2. To compare the effects of liraglutide on BMI and fat mass in participants who had a poor initial response to SG vs. those with a typical post-SG weight loss (≥20% BMI reduction at BMI nadir). Liraglutide treatment for 16 weeks was associated with a mean BMI reduction of 4.3% in adolescents and young adults who had previously undergone SG, quantitatively similar to results obtained in adolescents with obesity who had not undergone bariatric surgery after 16 and 56 weeks of liraglutide. Male and female adolescents age 12 to 20.999 years old who underwent SG at least 1 year prior to enrollment and have BMI ≥30 kg or ≥95th percentile for age and sex in order to enroll at least 40 who are eligible and agree to take liraglutide for 16 weeks.

来自PFCBT表格的数据
研究概况
本试验为一项开放标签Ⅱ期非随机先导研究，由美国国立卫生研究院（National Institutes of Health, NIH）临床中心开展，旨在探讨每日皮下注射利拉鲁肽（liraglutide）——一种胰高血糖素样肽-1（glucagon-like peptide-1, GLP1）类似物——的疗效，该药物用于降低垂直袖状胃切除术（vertical sleeve gastrectomy, SG）后持续肥胖1年及以上的青少年的体质量指数（body mass index, BMI）。本研究假设，给予利拉鲁肽可使BMI降低。
主要研究目标为：明确16周时，3.0mg利拉鲁肽对BMI变化的效应量。
次要研究目标包括：
1. 探讨利拉鲁肽对平均BMI及脂肪量变化的影响；
2. 对比利拉鲁肽对初始SG应答不佳者与术后体重减轻典型者（BMI低谷期降幅≥20%）的BMI及脂肪量影响。
针对既往接受过SG的青少年及年轻成人，16周利拉鲁肽治疗可使平均BMI降低4.3%，该效果的量化结果与未接受减重手术的肥胖青少年接受16周及56周利拉鲁肽治疗后的结果相近。
本研究的入组标准为：年龄介于12至20.999岁的男女青少年，入组前至少1年接受过SG手术，且BMI≥30kg或符合其年龄与性别对应的第95百分位数；本研究计划纳入至少40名符合入组标准且同意接受16周利拉鲁肽治疗的受试者。