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Growth Hormone

Phase 2

TBI (Traumatic Brain Injury) | Monoclonal antibody | Endocrine |Novo Nordisk A/S|Last Updated: Feb 8, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04121780Growth Hormone Replacement Therapy for Retried Professional Football PlayersPHASE2 RECRUITING 42Oct 8, 2019Sep 1, 2026Feb 8, 20231 United States
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Study Endpoints
Primary Endpoints
Cognitive functions- Working Memory
From baseline to 1-year post-treatment

To assess change in working memory from base line to 1 yr post-treatment. Working memory will be reported as an index score based on scaled scores for the digit span subtest and symbol span subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning.

Cognitive functions- Processing Speed
From baseline to 1-year post-treatment

To assess change in Processing Speed from baseline to 1 yr post-treatment. Processing speed will be reported as an index score based on scaled scores of digit symbol subtest and symbol search subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning. Trail Making Test A will also be used to assess processing speed. Reported as T-score. Higher scores reflect better performance.

Cognitive functions- Executive Function.
From baseline to 1-year post-treatment

To assess change in Executive Function from baseline to 1 yr post-treatment. Trail Making Test B and verbal fluency (letter and category) will be used to assess executive function. Reported as T-score. T scores have a mean of 50 and a standard deviation of 10. Scores range from 13 to 87. Higher scores reflect better performance.

Cognitive functions- Verbal learning and memory
From baseline to 1-year post-treatment

To assess change in Verbal learning and memory from baseline to 1 yr post-treatment. California verbal learning test will be used to assess this outcome measure. Reported as a standard score with a mean of 0 and a standard deviation of 1. Scores range from -0.5 to +5.0. Higher scores reflect better performance.

Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)
From baseline to 1-year post-treatment

To assess change in ANAM from baseline to 1 yr post-treatment. ANAM Test System- Core Battery will be used to assess this outcome measure. Reported as a standard score

Secondary Endpoints
Quality of Life Assessment of Growth Hormone Deficiency in Adults
One year (from baseline to 1-year post-treatment)
Change in QEEG Markers- power spectra
One year (from baseline to 1-year post-treatment)
Change in QEEG Markers- Connectivity Measures
One year (from baseline to 1-year post-treatment)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Growth HormoneEXPERIMENTALNorditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
SalinePLACEBO_COMPARATORSaline-placebo via auto-injector pens (Haselmeier Inc).
Interventions
NameTypeDescription
Growth HormoneBIOLOGICALDaily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase
PlaceboOTHERDaily self-injections by subjects: 1-year double-blind phase
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Eligibility Criteria
Age Range18 Years — 76 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study. * Former NFL player * At least one year since retirement from football * Less than...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04121780primaryCompletionDate: changed
LOWMay 24, 2026NCT04121780studyFirstPostDate: changed