跳至主要内容
临床试验/EUCTR2008-001049-24-IT
EUCTR2008-001049-24-IT进行中(未招募)不适用

Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with co-morbiditiesA randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either one or three years of treatment based on pre-diabetes status at randomisation - eliot

OVO NORDISK0 个研究点目标入组 4,800 人开始时间: 2008年10月13日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
4,800

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

  • 1.Informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject)
  • 2.Body Mass Index (BMI)  30.0 kg/m2 or  27 kg/m2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia according to ATP-III)
  • 3.Stable body weight (less than 5 kg self-reported change during the previous 3 months)
  • 4.Preceding failed dietary effort
  • 5.Age ≥ 18 years
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Diagnosis of type 1 or type 2 diabetes per the judgement of the Investigator
  • HbA1c ≥ 7 % at Visit 1
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Obesity induced by drug treatment
  • Use of approved weight lowering pharmacotherapy
  • Previous surgical treatment of obesity
  • History of major depressive desorder or suicide attempt
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)

研究者

发起方
OVO NORDISK

相似试验

进行中(未招募)
不适用
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetes
EUCTR2008-001049-24-DKovo Nordisk A/S3,600
进行中(未招募)
不适用
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetesObesity and overweightPre-diabetesMedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2008-001049-24-GBovo Nordisk A/S3,600
进行中(未招募)
1 期
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetesObesity and overweightPre-diabetesMedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2008-001049-24-IEovo Nordisk A/S3,600
进行中(未招募)
不适用
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetesObesity and overweightPre-diabetesMedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityMedDRA version: 9.1Level: LLTClassification code 10033307Term: Overweight
EUCTR2008-001049-24-NLovo Nordisk A/S3,600
进行中(未招募)
不适用
Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetesObesity and overweightPre-diabetesMedDRA version: 17.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 17.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2008-001049-24-FIovo Nordisk A/S3,600