NCT02963935已完成3 期
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change in Body Weight (%)
研究概览
简要总结
This trial is conducted in the United States of America (USA). The purpose of the trial is to investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS) visit schedule).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •BMI above or equal to 30 kg/m^2
- •Male or female, age 18 years or older at the time of signing informed consent
排除标准
- •HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus
- •Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
- •Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- •Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- •History of pancreatitis (acute or chronic)
- •History of major depressive disorder within the past 2 years
- •Any lifetime history of a suicide attempt
- •Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)
- •History of malignancy (except for non-melanoma skin cancer) within the past 5 years
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide (Drug)
Liraglutide
Experimental
干预措施: CMS Intensive Behavior Therapy (Behavioral)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Placebo
Placebo Comparator
干预措施: CMS Intensive Behavior Therapy (Behavioral)
结局指标
主要结局
Change in Body Weight (%)
时间窗: Week 0, week 56
Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
时间窗: Week 56
The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
次要结局
- Change in ECG(Week -1, week 56)
- Change in Laboratory Measurements: Haematology (Haemoglobin Blood)(Week 0, week 56)
- Change in Laboratory Measurements: Haematology (Haematocrit Blood)(Week 0, week 56)
- Change in Laboratory Measurements: Haematology (Erythrocytes)(Week 0, week 56)
- Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Albumin)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Calcitonin)(Week 0, week 56)
- Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)(Week 0, week 56)
- Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56(Week 56)
- Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56(Week 56)
- Proportion of Subjects Losing 4% or More of Baseline Body Weight(Week 16)
- Change in Waist Circumference (cm)(Week 0, week 56)
- Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score(Week 0, week 56)
- Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score(Week 0, week 56)
- Change in Six Minutes Walking Distance Test (6MWT)(Week 0, week 56)
- Change From Baseline in Lipids - TG(Week 0, week 56)
- Change From Baseline in Lipids - FFA(Week 0, week 56)
- Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)(Week 0, week 56)
- Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))(Week 0, week 56)
- Change From Baseline in HbA1c (%)(Week 0, week 56)
- Change From Baseline in FPG (mg/dL)(Week 0, week 56)
- Change From Baseline sBP (mmHg)(Week 0, week 56)
- Change From Baseline dBP (mmHg)(Week 0, week 56)
- Change From Baseline in Lipids -Total Cholesterol(Week 0, week 56)
- Change From Baseline in Lipids - LDL Cholesterol(Week 0, week 56)
- Change From Baseline in Lipids - HDL Cholesterol(Week 0, week 56)
- Change From Baseline in Lipids - VLDL Cholesterol(Week 0, week 56)
- Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)(Week 0, week 56)
- Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score(Week 0, week 56)
- Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score(Week 0, week 56)
- Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score(Week 0, week 56)
- Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score(Week 0, week 56)
- Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score(Week 56)
- Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score(Week 56)
- Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score(Week 56)
- Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score(Week 56)
- Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product(Week 0, week 56)
- Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet(Week 0, week 56)
- Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity(Week 0, week 56)
- Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity(Week 0, week 56)
- Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product(Week 0, week 56)
- AEs From Randomisation Until and Including the Follow-up Period(Week 0 to week 56+30 days)
- Change in Physical Examination(Week 1, week 56)
- Change in Resting Pulse(Week 0, week 56)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal InsulinMetabolism and Nutrition DisorderObesityNCT02963922Novo Nordisk A/S396
已完成
3 期
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal ImpairmentDiabetesDiabetes Mellitus, Type 2NCT01620489Novo Nordisk A/S279
已完成
3 期
The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01836523Novo Nordisk A/S1,398
已完成
3 期
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT00620282Novo Nordisk A/S49
已完成
1 期
Safety of Liraglutide in Pediatric Patients With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00943501Novo Nordisk A/S21