EUCTR2016-004124-26-GB进行中（未招募）1 期
A randomized, subject- and investigator-blinded, placebo-controlled study to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab in overweight and obese patients with type 2 diabetes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Type 2 diabetes with HbA1c between 7% and 10% at screening with stable treatment for 3 months prior to randomization
- •- Body Mass Index of 28 to 40 kg/m2 at screening
- •- Body weight between 65 and 140 kg at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Women of child-bearing potential unless they are using highly effective methods of contraception
- •- Diabetes other than Type 2 such as Type 1 diabetes, surgically induced diabetes, brittle type 2 diabetes as per investigator judgement, history of severe hypoglycemic episodes in the year preceding screening or hypoglycemic unawareness
- •- history of clinically significant arrythmias, heart failure, unstable angina, myocardial infarction or stroke, coronary artery bypass graft surgery, or percutaneous coronary intervention, deep vein thrombosis/pulmonary embolism, valve disorders or defects, pulmonary hypertension within 6 months of screening or 1 year for drug-eluting stents
- •- tachycardia
- •- use of anti-obesity medications, nutritional supplements or over the counter products ofr weight loss within 3 months of screening
- •- use of medications known to induce weight gain such as some anti-convulsant and psychotropic medications within 3
- •months of screening
- •- Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc)
- •- uncontrolled thyroid disease. Stable euthyroid patients on stable thyroid replacement therapy for at least 3 months of
- •screening are allowed
- •- Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis)
- •- Uncontrolled depression
- •- Use of skeletal muscle anabolic agents in any form for 3 months prior to screening
- •- Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min]
研究者
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