JPRN-jRCT2031230522招募中3 期
A Phase III, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in patients with obesity disease in Japanese
Kenmochi Hiroki0 个研究点目标入组 240 人开始时间: 2023年12月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Male or female, age >=18 years at the time of signing informed consent
- •2. BMI >=35 kg/m2 at screening with the presence of at least one obesity-related co-morbidity (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline*, OR
- •BMI >=27 kg/m2 at screening with the presence of at least two obesity-related co-morbidities (treated or untreated) according to the JASSO guideline*
- •For all trial patients, at least one co-morbidity should be the following (i)-(iii):
- •-Diagnosed with T2DM (defined as HbA1c >=6.5% [>=48 mmol/mol]) at least 180 days prior to screening
- •-HbA1c >=6.5% (48 mmol/mol) and <10% (86 mmol/mol) as measured by the central laboratory at screening
- •-Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT-2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone) according to local label
- •ii.Hypertension
- •iii.Dyslipidemia
- •3. History of at least one self-reported unsuccessful dietary effort to lose body weight
排除标准
- •1. Body weight change (self-reported) of >5% within 3 months before screening
- •2. Treatment with any medication for the indication obesity within 3 months before screening
- •3. QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- •4. Heart failure (HF) with New York Heart Association (NYHA) functional class IV
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