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临床试验/NCT02229851
NCT02229851已完成3 期

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2014年10月31日最近更新:
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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
301
试验地点
1
主要终点
Change in Truncal Fat Percentage (Week 34)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

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
23 Years 至 79 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
  • •Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)
  • •If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
  • •FOR ALL COUNTRIES EXCEPT JAPAN:
  • •Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):
  • •Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
  • •Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2, a peak GH less than 4 ng/mL (4 mcg/L)
  • •Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):
  • •a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

排除标准

  • •Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin
  • •Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file

研究组 & 干预措施

NNC0195-0092 (somapacitan)

Experimental

干预措施: somapacitan (Drug)

Daily hGH

Active Comparator

干预措施: somatropin (Drug)

Placebo

Placebo Comparator

Switch to NNC0195-0092 (somapacitan) treatment in the extension period.

干预措施: somapacitan (Drug)

Placebo

Placebo Comparator

Switch to NNC0195-0092 (somapacitan) treatment in the extension period.

干预措施: placebo (Drug)

结局指标

主要结局

Change in Truncal Fat Percentage (Week 34)

时间窗: Week -3, week 34

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

次要结局

  • Change in Android Fat Mass (Week 34)(Week -3, week 34)
  • Change in Bone Mineral Density (Week 87)(week -3, week 87)
  • Change in IGF-I SDS (Week 34)(Week -3, week 34)
  • TSQM-9 Scores (Domain Scores) (Week 34)(Week 34)
  • Change in Total Cholesterol (Week 34)(Week -3, week 34)
  • Change in Total Cholesterol (Week 87)(week -3, week 87)
  • Change in HDL-cholesterol (Week 34)(Week -3, week 34)
  • Change in LDL-cholesterol (Week 34)(Week -3, week 34)
  • Change in Bone Mineral Content (Week 87)(week -3, week 87)
  • Change in Truncal Fat Mass (Week 34)(Week -3, week 34)
  • Change in Truncal Fat Mass (Week 87)(week -3, week 87)
  • Change in Gynoid Fat Mass (Week 34)(Week -3, week 34)
  • Change in Appendicular Skeletal Muscle Mass (Week 34)(Week -3, week 34)
  • Change in Truncal Fat Percentage (Week 87)(week -3, week 87)
  • Change in Total Fat Mass (Week 34)(Week -3, week 34)
  • Change in Total Fat Mass (Week 87)(Week -3, week 87)
  • Change in Visceral Adipose Tissue (Week 34)(Week -3, week 34)
  • Change in Visceral Adipose Tissue (Week 87)(Week -3, week 87)
  • Change in Lean Body Mass (Week 87)(week -3, week 87)
  • Change in Gynoid Fat Mass (Week 87)(week -3, week 87)
  • Change in Truncal Lean Body Mass (Week 34)(Week -3, week 34)
  • Change in Truncal Lean Body Mass (Week 87)(week -3, week 87)
  • Change in Appendicular Skeletal Muscle Mass (Week 87)(week -3, week 87)
  • Change in Lean Body Mass (Week 34)(Week -3, week 34)
  • Change in SF-36v2 (Summary and Domain Scores) (Week 34)(Week 0, week 34)
  • Change in Triglycerides (Week 87)(week -3, week 87)
  • Change in Physical Examination During Exposure to Trial Product (Week 35)(Week 0 and week 35)
  • Change in Haemoglobin (Week 87)(week -3, week 87)
  • Change in Android Fat Mass (Week 87)(week -3, week 87)
  • Change in IGFBP 3 SDS (Week 87)(Week -3, week 87)
  • Change in SF-36v2 (Summary and Domain Scores) (Week 87)(week 0, week 87)
  • TSQM-9 Scores (Domain Scores) (Week 87)(Week 87)
  • Change in LDL-cholesterol (Week 87)(week -3, week 87)
  • Change in Erythrocytes (Week 34)(Week -3, week 34)
  • Change in Alkaline Phosphatase (AP) (Week 87)(Week -3, week 87)
  • Change in IGF-I SDS (Week 87)(Week -3, week 87)
  • Change in IGFBP 3 SDS (Week 34)(Week -3, week 34)
  • Change in TRIM-AGHD (Total and Domain Scores) (Week 34)(Week 0, week 34)
  • Change in TRIM-AGHD (Total and Domain Scores) (Week 87)(week 0, week 87)
  • Change in HDL-cholesterol (Week 87)(week -3, week 87)
  • Change in Hs-CRP (Week 87)(week -3, week 87)
  • Change in IL-6 (Week 34)(Week -3, week 34)
  • Change in IL-6 (Week 87)(week -3, week 87)
  • Change in Body Weight (Week 34)(Week -3, week 34)
  • Change in Mean Corpuscular Volume (MCV) (Week 87)(week -3, week 87)
  • Number of Adverse Events (Weeks 0-88)(Weeks 0-88)
  • Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)(Weeks 0 to 88)
  • Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)(Week -3 and week 35)
  • Change in Diastolic Blood Pressure (Week 88)(Week -3, week 88)
  • Change in Pulse (Week 35)(Week -3, week 35)
  • Change in Haematocrit (Week 87)(week -3, week 87)
  • Change in Potassium (Week 87)(week -3, week 87)
  • Change in Triglycerides (Week 34)(Week -3, week 34)
  • Number of Adverse Events (Weeks 0-35)(Weeks 0-35)
  • Change in ECG Evaluation During Exposure to Trial Product (Week 88)(Week -3 and week 88)
  • Change in Systolic Blood Pressure (Week 35)(Week -3, week 35)
  • Change in Haemoglobin (Week 34)(Week -3, week 34)
  • Change in Haematocrit (Week 34)(Week -3, week 34)
  • Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)(week -3, week 87)
  • Change in Thrombocytes (Week 34)(Week -3, week 34)
  • Change in Thrombocytes (Week 87)(week -3, week 87)
  • Change in Leucocytes (Week 34)(Week -3, week 34)
  • Change in Leucocytes (Week 87)(week -3, week 87)
  • Change in Hs-CRP (Week 34)(Week -3, week 34)
  • Change in Body Weight (Week 87)(week -3, week 87)
  • Change in Waist Circumference (Week 34)(Week -3, week 34)
  • Change in Physical Examination During Exposure to Trial Product (Week 88)(Week 0 and week 88)
  • Change in Systolic Blood Pressure (Week 88)(Week -3, week 88)
  • Change in Pulse (Week 88)(Week -3, week 88)
  • Change in Erythrocytes (Week 87)(week -3, week 87)
  • Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)(Week -3, week 34)
  • Change in Albumin (Week 34)(Week -3, week 34)
  • Change in Albumin (Week 87)(week -3, week 87)
  • Change in Waist Circumference (Week 87)(week -3, week 87)
  • Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)(Weeks 0 to 35)
  • Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)(Weeks 0 to 88)
  • Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)(Weeks 0 to 35)
  • Change in Diastolic Blood Pressure (Week 35)(Week -3, week 35)
  • Change in Mean Corpuscular Volume (MCV) (Week 34)(Week -3, week 34)
  • Change in Alanine Aminotransferase (ALT) (Week 34)(Week -3, week 34)
  • Change in Alanine Aminotransferase (ALT) (Week 87)(week -3, week 87)
  • Change in Alkaline Phosphatase (ALP) (Week 34)(Week -3, week 34)
  • Change in Aspartate Aminotransferase (AST) (Week 87)(Week -3, week 87)
  • Change in Chloride (Week 87)(week -3, week 87)
  • Change in Creatinine (Week 87)(week -3, week 87)
  • Change in Gamma-glutamyl Transferase (GGT) (Week 34)(Week -3, week 34)
  • Change in Potassium (Week 34)(Week -3, week 34)
  • Change in Sodium (Week 34)(Week -3, week 34)
  • Change in Uric Acid (Week 87)(week -3, week 87)
  • Change in Fasting Plasma Glucose (Week 87)(week -3, week 87)
  • Change in Insulin Resistance (IR %) (Week 87)(week -3, week 87)
  • Change in Phosphate (Inorganic) (Week 34)(Week -3, week 34)
  • Change in Phosphate (Inorganic)(Week 87)(week -3, week 87)
  • Change in Urea (Week 87)(week -3, week 87)
  • Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)(Week -3, week 34)
  • Change in Fasting Insulin (Week 87)(week -3, week 87)
  • Change in Steady State Beta Cell Function (%B) (Week 87)(week -3, week 87)
  • Change in Aspartate Aminotransferase (AST) (Week 34)(Week -3, week 34)
  • Change in Bilirubin (Week 34)(Week -3, week 34)
  • Change in Calcium (Week 34)(Week -3, week 34)
  • Change in Calcium (Week 87)(week -3, week 87)
  • Change in Chloride (Week 34)(Week -3, week 34)
  • Change in Creatine Kinase (Week 34)(Week -3, week 34)
  • Change in Creatine Kinase (Week 87)(week -3, week 87)
  • Change in Insulin Resistance (IR %) (Week 34)(Week -3, week 34)
  • Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)(week -3, week 87)
  • Change in Bilirubin (Week 87)(week -3, week 87)
  • Change in Creatinine (Week 34)(Week -3, week 34)
  • Change in Gamma-glutamyl Transferase (GGT) (Week 87)(week -3, week 87)
  • Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)(week -3, week 87)
  • Change in Fasting Insulin (Week 34)(Week -3, week 34)
  • Change in Sodium (Week 87)(week -3, week 87)
  • Change in Total Protein (Week 34)(Week -3, week 34)
  • Change in Total Protein (Week 87)(week -3, week 87)
  • Change in Urea (Week 34)(Week -3, week 34)
  • Change in Uric Acid (Week 34)(Week -3, week 34)
  • Change in Fasting Plasma Glucose (Week 34)(Week -3, week 34)
  • Change in Steady State Beta Cell Function (%B) (Week 34)(Week -3, week 34)
  • Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)(Week -3, week 34)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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