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A study evaluating the safety and efficacy of once-weekly dosing of somapacitan in a basket study design in paediatric participants with short stature either born small of gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501055-87-01
Acronym
NN8640-4469
Enrollment
20
Registered
2023-03-27
Start date
2023-05-18
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic short stature, Noonan syndrome, Small for gestational age, Turner’s syndrome

Brief summary

Number of adverse events (AEs) from week 0 to week 26

Detailed description

Number of adverse events (AEs) possibly or probably related to somapacitan from week 0 to week 26, Number of adverse events (AEs) from week 0 to week 156, Height Velocity from week 0 to week 26, Change in Height SDS from week 0 to week 26, Change in Height Velocity SDS from week 0 to week 26, Change in IGF-1 SDS from week 0 to week 26, Change in IGFBP-3 SDS from week 0 to week 26, Weekly average somapacitan concentration (C[avg]) based on population PK analysis from week 0 to week 26

Interventions

DRUGSomapacitan 15 mg/1.5 ml PDS290

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Number of adverse events (AEs) from week 0 to week 26—

Secondary

MeasureTime frame
Number of adverse events (AEs) possibly or probably related to somapacitan from week 0 to week 26, Number of adverse events (AEs) from week 0 to week 156, Height Velocity from week 0 to week 26, Change in Height SDS from week 0 to week 26, Change in Height Velocity SDS from week 0 to week 26, Change in IGF-1 SDS from week 0 to week 26, Change in IGFBP-3 SDS from week 0 to week 26, Weekly average somapacitan concentration (C[avg]) based on population PK analysis from week 0 to week 26—

Countries

Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026