Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02229851
• Date of registration: 26/08/2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. REAL 1
• Scientific title: 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
• Date of first enrolment: October 31, 2014
• Target sample size: 301
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02229851
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Germany, India, Israel, Japan, Latvia, Lithuania, Malaysia, Norway, Poland, Romania, Russian Federation, South Africa, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Reporting Anchor and Disclosure' (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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):

1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL
(3 mcg/L)

2. 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)

3. 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)

Exclusion Criteria:

- 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



Age minimum: 23 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency

Growth Hormone Disorder

Intervention(s)

Drug: somatropin

Drug: somapacitan

Drug: placebo

Primary Outcome(s)

Change in Truncal Fat Percentage (Week 34) [Time Frame: Week -3, week 34]

Secondary Outcome(s)

Change in Body Weight (Week 87) [Time Frame: week -3, week 87]

Change in Creatinine (Week 34) [Time Frame: Week -3, week 34]

Change in Erythrocytes (Week 34) [Time Frame: Week -3, week 34]

Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) [Time Frame: Week -3, week 34]

Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) [Time Frame: Week -3, week 34]

Change in Gynoid Fat Mass (Week 34) [Time Frame: Week -3, week 34]

Change in Haematocrit (Week 87) [Time Frame: week -3, week 87]

Change in HDL-cholesterol (Week 34) [Time Frame: Week -3, week 34]

Change in Android Fat Mass (Week 34) [Time Frame: Week -3, week 34]

Change in Appendicular Skeletal Muscle Mass (Week 87) [Time Frame: week -3, week 87]

Change in IL-6 (Week 34) [Time Frame: Week -3, week 34]

Change in IL-6 (Week 87) [Time Frame: week -3, week 87]

Change in Alanine Aminotransferase (ALT) (Week 34) [Time Frame: Week -3, week 34]

Change in Alkaline Phosphatase (AP) (Week 87) [Time Frame: Week -3, week 87]

Change in Bilirubin (Week 34) [Time Frame: Week -3, week 34]

Change in Bilirubin (Week 87) [Time Frame: week -3, week 87]

Change in Aspartate Aminotransferase (AST) (Week 87) [Time Frame: Week -3, week 87]

Change in Diastolic Blood Pressure (Week 35) [Time Frame: Week -3, week 35]

Change in Pulse (Week 35) [Time Frame: Week -3, week 35]

Change in Sodium (Week 87) [Time Frame: week -3, week 87]

Change in Body Weight (Week 34) [Time Frame: Week -3, week 34]

Change in Calcium (Week 34) [Time Frame: Week -3, week 34]

Change in Alanine Aminotransferase (ALT) (Week 87) [Time Frame: week -3, week 87]

Change in Alkaline Phosphatase (ALP) (Week 34) [Time Frame: Week -3, week 34]

Change in Calcium (Week 87) [Time Frame: week -3, week 87]

Change in Fasting Insulin (Week 87) [Time Frame: week -3, week 87]

Change in Bone Mineral Density (Week 87) [Time Frame: week -3, week 87]

Change in Chloride (Week 87) [Time Frame: week -3, week 87]

Change in Appendicular Skeletal Muscle Mass (Week 34) [Time Frame: Week -3, week 34]

Change in Creatinine (Week 87) [Time Frame: week -3, week 87]

Change in Albumin (Week 34) [Time Frame: Week -3, week 34]

Change in Android Fat Mass (Week 87) [Time Frame: week -3, week 87]

Change in Chloride (Week 34) [Time Frame: Week -3, week 34]

Change in Creatine Kinase (Week 87) [Time Frame: week -3, week 87]

Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) [Time Frame: Week -3 and week 35]

Change in Diastolic Blood Pressure (Week 88) [Time Frame: Week -3, week 88]

Change in Haematocrit (Week 34) [Time Frame: Week -3, week 34]

Change in Gamma-glutamyl Transferase (GGT) (Week 34) [Time Frame: Week -3, week 34]

Change in Physical Examination During Exposure to Trial Product (Week 35) [Time Frame: Week 0 and week 35]

Change in Fasting Insulin (Week 34) [Time Frame: Week -3, week 34]

Change in Gynoid Fat Mass (Week 87) [Time Frame: week -3, week 87]

Change in Hs-CRP (Week 87) [Time Frame: week -3, week 87]

Change in IGF-I SDS (Week 34) [Time Frame: Week -3, week 34]

Change in SF-36v2 (Summary and Domain Scores) (Week 34) [Time Frame: Week 0, week 34]

Change in Steady State Beta Cell Function (%B) (Week 34) [Time Frame: Week -3, week 34]

Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) [Time Frame: week -3, week 87]

Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) [Time Frame: week -3, week 87]

Change in LDL-cholesterol (Week 34) [Time Frame: Week -3, week 34]

Change in Mean Corpuscular Volume (MCV) (Week 34) [Time Frame: Week -3, week 34]

Change in Steady State Beta Cell Function (%B) (Week 87) [Time Frame: week -3, week 87]

Change in Systolic Blood Pressure (Week 35) [Time Frame: Week -3, week 35]

Change in Phosphate (Inorganic) (Week 34) [Time Frame: Week -3, week 34]

Change in Phosphate (Inorganic)(Week 87) [Time Frame: week -3, week 87]

Change in Mean Corpuscular Volume (MCV) (Week 87) [Time Frame: week -3, week 87]

Change in Triglycerides (Week 34) [Time Frame: Week -3, week 34]

Change in Physical Examination During Exposure to Trial Product (Week 88) [Time Frame: Week 0 and week 88]

Change in Total Cholesterol (Week 87) [Time Frame: week -3, week 87]

Change in Thrombocytes (Week 87) [Time Frame: week -3, week 87]

Change in Triglycerides (Week 87) [Time Frame: week -3, week 87]

Change in Truncal Fat Mass (Week 34) [Time Frame: Week -3, week 34]

Change in Uric Acid (Week 87) [Time Frame: week -3, week 87]

Change in Aspartate Aminotransferase (AST) (Week 34) [Time Frame: Week -3, week 34]

Change in Bone Mineral Content (Week 87) [Time Frame: week -3, week 87]

Change in Thrombocytes (Week 34) [Time Frame: Week -3, week 34]

Change in TRIM-AGHD (Total and Domain Scores) (Week 34) [Time Frame: Week 0, week 34]

Change in Waist Circumference (Week 34) [Time Frame: Week -3, week 34]

Change in Waist Circumference (Week 87) [Time Frame: week -3, week 87]

Change in Creatine Kinase (Week 34) [Time Frame: Week -3, week 34]

Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) [Time Frame: week -3, week 87]

Change in Visceral Adipose Tissue (Week 87) [Time Frame: Week -3, week 87]

Change in Urea (Week 87) [Time Frame: week -3, week 87]

Number of Adverse Events (Weeks 0-35) [Time Frame: Weeks 0-35]

Change in ECG Evaluation During Exposure to Trial Product (Week 88) [Time Frame: Week -3 and week 88]

Change in Erythrocytes (Week 87) [Time Frame: week -3, week 87]

Change in Fasting Plasma Glucose (Week 34) [Time Frame: Week -3, week 34]

Change in Haemoglobin (Week 34) [Time Frame: Week -3, week 34]

Change in Fasting Plasma Glucose (Week 87) [Time Frame: week -3, week 87]

Change in Gamma-glutamyl Transferase (GGT) (Week 87) [Time Frame: week -3, week 87]

Change in HDL-cholesterol (Week 87) [Time Frame: week -3, week 87]

Change in Hs-CRP (Week 34) [Time Frame: Week -3, week 34]

Number of Adverse Events (Weeks 0-88) [Time Frame: Weeks 0-88]

Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) [Time Frame: Weeks 0 to 88]

Change in Potassium (Week 34) [Time Frame: Week -3, week 34]

Change in Pulse (Week 88) [Time Frame: Week -3, week 88]

Change in IGF-I SDS (Week 87) [Time Frame: Week -3, week 87]

Change in Insulin Resistance (IR %) (Week 87) [Time Frame: week -3, week 87]

TSQM-9 Scores (Domain Scores) (Week 87) [Time Frame: Week 87]

Change in Leucocytes (Week 34) [Time Frame: Week -3, week 34]

Change in SF-36v2 (Summary and Domain Scores) (Week 87) [Time Frame: week 0, week 87]

Change in Total Protein (Week 87) [Time Frame: week -3, week 87]

Change in Urea (Week 34) [Time Frame: Week -3, week 34]

Change in Total Cholesterol (Week 34) [Time Frame: Week -3, week 34]

Change in Total Fat Mass (Week 87) [Time Frame: Week -3, week 87]

Change in IGFBP 3 SDS (Week 34) [Time Frame: Week -3, week 34]

Change in Insulin Resistance (IR %) (Week 34) [Time Frame: Week -3, week 34]

Change in Visceral Adipose Tissue (Week 34) [Time Frame: Week -3, week 34]

Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) [Time Frame: Weeks 0 to 88]

Change in Truncal Fat Mass (Week 87) [Time Frame: week -3, week 87]

Change in Truncal Fat Percentage (Week 87) [Time Frame: week -3, week 87]

Change in Lean Body Mass (Week 87) [Time Frame: week -3, week 87]

Change in Leucocytes (Week 87) [Time Frame: week -3, week 87]

Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) [Time Frame: Weeks 0 to 35]

TSQM-9 Scores (Domain Scores) (Week 34) [Time Frame: Week 34]

Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) [Time Frame: Week -3, week 34]

Change in Potassium (Week 87) [Time Frame: week -3, week 87]

Change in Sodium (Week 34) [Time Frame: Week -3, week 34]

Change in Systolic Blood Pressure (Week 88) [Time Frame: Week -3, week 88]

Change in Total Fat Mass (Week 34) [Time Frame: Week -3, week 34]

Change in Total Protein (Week 34) [Time Frame: Week -3, week 34]

Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) [Time Frame: Weeks 0 to 35]

Change in Truncal Lean Body Mass (Week 87) [Time Frame: week -3, week 87]

Change in Albumin (Week 87) [Time Frame: week -3, week 87]

Change in Haemoglobin (Week 87) [Time Frame: week -3, week 87]

Change in IGFBP 3 SDS (Week 87) [Time Frame: Week -3, week 87]

Change in LDL-cholesterol (Week 87) [Time Frame: week -3, week 87]

Change in Lean Body Mass (Week 34) [Time Frame: Week -3, week 34]

Change in TRIM-AGHD (Total and Domain Scores) (Week 87) [Time Frame: week 0, week 87]

Change in Truncal Lean Body Mass (Week 34) [Time Frame: Week -3, week 34]

Change in Uric Acid (Week 34) [Time Frame: Week -3, week 34]

Secondary ID(s)

U1111-1145-0211

NN8640-4054

2013-002892-16

JapicCTI-152767

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02229851