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somatropin- GH naïve pediatric cohort

Phase 3

Prader-Willi Syndrome | Monoclonal antibody | Rare Disease |Pfizer, Inc.|Last Updated: Jan 14, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as somatropin - GH naïve pediatric cohort

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

somatropin- GH naïve pediatric cohort · 1 trial · 1 indication

Phase 3 1
NCT04697381Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWSPrader-Willi Syndrome
COMPLETED33 Analytics
PHASE3COMPLETED
Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS
Prader-Willi Syndrome
NCT0469738133
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Study Endpoints

Primary Endpoints

Change From Baseline to Month 12 in Lean Body Mass Measured by Dual-Energy X-ray Absorptiometry (DEXA): Adult Cohort
Baseline, Month 12

Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass kilogram (kg) / (lean body mass \[kg\] + fat mass \[kg\]) \*100.

Change From Baseline to Month 12 in Lean Body Mass Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort
Baseline, Month 12

Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass \[kg\] + fat mass \[kg\])\*100.

Secondary Endpoints

Change From Baseline to Month 12 in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA)-Adult Cohort
Baseline, Month 12
Change From Baseline to Month 12 in Lean Body Mass Measured by BIA-GH Naive Pediatric and GH Treated Pediatric Cohort
Baseline, Month 12
Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: Adult Cohort
Baseline, Month 12
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
somatropin - GH naïve pediatric cohortEXPERIMENTALAll participants will receive somatropin.
somatropin - GH treated pediatric cohortEXPERIMENTALAll participants will receive somatropin
somatropin - adult cohortEXPERIMENTALAll participants will receive somatropin

Interventions

NameTypeDescription
somatropin - GH naïve pediatric cohortBIOLOGICALsomatropin 0.245 mg/kg/week
somatropin - GH treated cohortBIOLOGICALsomatropin 0.084 mg/kg/week
somatropin - adult cohortBIOLOGICALsomatropin 0.084 mg/kg/week
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Eligibility Criteria

Age Range0 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Male or female participants with documentation of genetically confirmed diagnosis of PWS. 2. No plan to initiate a new treatment that may affect the body composition, such as gonadal hormone replacement therapy. 3. Currently on appropriate diet and exercise programs and willi...

Countries:Japan
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