Phase 3
Completed N=62
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Growth Hormone Disorder · Adult Growth Hormone Deficiency
Source: ClinicalTrials.gov NCT03075644 ↗
Enrolled (actual)
62
Serious AEs
6.5%
Results posted
Oct 2020
Primary outcomePrimary: Incidence of Adverse Events, Including Injection Site Reactions — 309.8; 312.7 Event rate per 100 patient years
◆ Published Evidence
Established
36citations · ~6 / year
Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.
Summary
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.
Linked Publications (2)
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Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.
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Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events, Including Injection Site Reactions |
309.8; 312.7 | — |
| SECONDARY Change in Cross-sectional Total Adipose Tissue Compartments |
7.450; -7.091 | — |
| SECONDARY Change in Subcutaneous Adipose Tissue Compartments |
6.779; -5.033 | — |
| SECONDARY Change in Intra-abdominal or Visceral Adipose Tissue Compartments |
0.671; -2.618 | — |
| SECONDARY Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores |
3.6; 7.9; 8.7; 13.3; 3.1; 10.0 | — |
| SECONDARY Change in Physical Examination |
15; 45; 0; 1; 1; 0 | — |
| SECONDARY Change in Body Weight |
0.66; -0.29 | — |
| SECONDARY Change in SBP and DBP |
-3.1; -3.3; 1.1; 0.9 | — |
| SECONDARY Change in Pulse |
-1.1; 1.4 | — |
| SECONDARY Change in ECG |
16; 39; 0; 7; 0; 0 | — |
| SECONDARY Change in Haematology: Haemoglobin |
-2.071; 0.311 | — |
| SECONDARY Change in Haematology: Haematocrit |
-0.64; 0.04 | — |
| SECONDARY Change in Haematology: Thrombocytes, Leucocytes |
0.1; 5.7; -0.29; -0.50 | — |
| SECONDARY Change in Haematology: Erythrocytes |
-0.086; -0.007 | — |
| SECONDARY Change in Haematology: Mean Corpuscular Volume |
0.00; 0.29 | — |
| SECONDARY Change in Haematology: Mean Corpuscular Haemoglobin Concentration |
0.04; 0.05 | — |
| SECONDARY Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) |
1.4; 1.0; 25.9; 6.7; -0.21; 0.56 | — |
| SECONDARY Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT |
-10.4; 6.8; -4.9; -1.6; -3.2; -1.4 | — |
| SECONDARY Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) |
0.29; 0.71; -0.3; 0.2; -0.04; 0.04 | — |
| SECONDARY Change in Biochemistry: Total Protein and Albumin |
-0.6; 1.4; 0.3; 1.3 | — |
| SECONDARY Change in Biochemistry: eGFR Creatinine |
-1.4; -1.4 | — |
| SECONDARY Change in HbA1c |
-0.04; -0.07 | — |
| SECONDARY Change in FPG |
0.014; 0.089 | — |
| SECONDARY Change in Fasting Insulin |
-16.7; -8.7 | — |
| SECONDARY Change in Steady State Beta Cell Function |
-23.58; -19.06 | — |
| SECONDARY Change in Insulin Resistance |
-0.60; -0.25 | — |
| SECONDARY Occurrence of Anti-somapacitan Antibodies |
0; 0 | — |
| SECONDARY Occurrence of Anti-hGH Antibodies |
0; 1; 0; 0 | — |
| SECONDARY Incidence of Clinical Technical Complaints |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - 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 Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ 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 medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation
Data sourced from ClinicalTrials.gov (NCT03075644) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.