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Inpegsomatropin

Phase 2

Adult Growth Hormone Deficiency | Small molecule | Endocrine |Co-Diagnostics, Inc.|Last Updated: May 26, 2026

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07551804Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone DeficiencyPHASE2 NOT YET_RECRUITING 36 — — May 31, 2026Jun 30, 2028May 26, 20266 China
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Study Endpoints
Primary Endpoints
Adverse Event
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Serious Adverse Event
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of Participants with Abnormal Laboratory Parameters Findings
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
HR (bpm)
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
PR (ms)
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QRS (ms)
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QT (ms)
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QTc (ms)
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of participants with clinically significant changes in imaging examinations
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body weight
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body Mass Index
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body temperature
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
pulse
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
blood pressure
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Respiration
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Trunk fat percentage
Week 25
Trunk fat mass
Week 25
Total fat mass
Week 25
Visceral adipose tissue (VAT)
Week 25
Lean body mass (LBM)
Week 25
Bone mineral density (BMD)
Week 25
Quality of life score (QoL score)
Week 25
BMI
Week1Day1,Week25Day1
Change from baseline in waist-to-hip ratio
Week3Day1,Week25Day1
IGF-I /IGFBP-3
Week1Day1,Week25Day1
Cmax
Week1Day1,Week25Day1
Cmin
Week1Day1,Week25Day1
Tmax
Week1Day1,Week25Day1
AUC0-t
Week1Day1,Week25Day1
AUC0-∞
Week1Day1,Week25Day1
AUC0-tau
Week1Day1,Week25Day1
Rac_Cmax
Week1Day1,Week25Day1
Rac_AUC0-tau
Week1Day1,Week25Day1
CL/F
Week1Day1,Week25Day1
Vz/F
Week1Day1,Week25Day1
DF
Week1Day1,Week25Day1
t1/2
Week1Day1,Week25Day1
ADA
Week1Day1,Week29Day1
NAb
Week1Day1,Week29Day1
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A group: Inpegsomatropin Injection low doseEXPERIMENTAL -
A group:Placebo for Inpegsomatropin Injection low dosePLACEBO_COMPARATOR -
B group: Inpegsomatropin Injection middle doseEXPERIMENTAL -
B group:Placebo for Inpegsomatropin Injection middle dosePLACEBO_COMPARATOR -
C group: Experimental:telpegfilgrastim Injection highEXPERIMENTAL -
C group:Placebo for Inpegsomatropin Injection high dosePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Inpegsomatropin InjectionDRUGInpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week
Placebo for Inpegsomatropin InjectionDRUGPlacebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week
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Eligibility Criteria
Age Range18 Years — 80 Years
SexMALE
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male study participants aged ≥ 18 years and \< 80 years at the time of signing the informed consent form (ICF); * Study participants meeting the criteria for adult growth hormone deficiency (AGHD): Patients with a peak GH level \< 5 μg/L measured by insulin tolerance test (IT...

Countries:China
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