Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, sixteen-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator

ovo Nordisk A/S0 个研究点目标入组 957 人开始时间: 2015年7月20日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•2. Male or female, age = 18 years at the time of signing inform consent
•3. Body mass index (BMI) = 30.0 kg/m^2 at the screening visit
•4. At least one unsuccessful weight loss attempt per investigator judgement
•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 885
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. A HbA1c = 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
•2. Treatment with glucose lowering agent(s) within 90 days before screening
•3. Screening calcitonin = 50 ng/L (pg/mL)
•4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
•5. History of pancreatitis (acute or chronic)
•6. Obesity induced by endocrine disorders (e.g. Cushing Syndrome)
•7.Treatment with any medication within 90 days before screening that based on investigator’s judgement may cause significant weight change
•8. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed > 1 year before screening is allowed)
•9. History of major depressive disorder within 2 years before randomisation
•10. Any lifetime history of a suicidal attempt
•11. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

发起方