Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
somatropin- GH naïve pediatric cohort · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| somatropin - GH naïve pediatric cohort | EXPERIMENTAL | All participants will receive somatropin. |
| somatropin - GH treated pediatric cohort | EXPERIMENTAL | All participants will receive somatropin |
| somatropin - adult cohort | EXPERIMENTAL | All participants will receive somatropin |
| Name | Type | Description |
|---|---|---|
| somatropin - GH naïve pediatric cohort | BIOLOGICAL | somatropin 0.245 mg/kg/week |
| somatropin - GH treated cohort | BIOLOGICAL | somatropin 0.084 mg/kg/week |
| somatropin - adult cohort | BIOLOGICAL | somatropin 0.084 mg/kg/week |
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...
Somatropin in the GH-naive pediatric cohort is being studied for Prader-Willi Syndrome, a rare genetic disorder. The Phase 3 program focuses on Japanese participants with PWS who have not previously received growth hormone treatment. It is a rare disease asset developed by Pfizer.
Pfizer, Inc. (ticker: PFE) is the developer of somatropin for the GH-naive pediatric cohort. The company is running the clinical program in Japan for pediatric patients with Prader-Willi Syndrome who have not been exposed to growth hormone therapy.
Somatropin for the GH-naive pediatric cohort is in Phase 3 development. The single registered trial, NCT04697381, has completed. It is an investigational asset and is not described as approved for this use.
The program includes one completed Phase 3 trial, NCT04697381, titled Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS. It enrolled 33 participants in Japan, included both sexes, and accepted participants from birth. The trial used a controlled design.
Somatropin for the GH-naive pediatric cohort is also known by that same name. It refers to the use of somatropin specifically in pediatric patients with Prader-Willi Syndrome who have not previously received growth hormone, as studied in the Pfizer Phase 3 program.
The completed Phase 3 trial NCT04697381 enrolled 33 participants. It was a controlled study conducted in Japan in participants with Prader-Willi Syndrome, with no minimum age restriction and both sexes eligible. It was not randomized or double blinded.