A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
← catalyst calendarSponsored by Novo Nordisk A/S (industry) · NVO — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
47actual
Sites
18
Countries
Malaysia, Netherlands, Poland +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-02-01 | actual | When the study began enrolling |
| Primary completion | 2024-06-07 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-10-29 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-13 | actual | When this record first appeared on the registry |
| Results posted | 2025-11-21 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- SGA
- Turner Syndrome
- Noonan Syndrome
- ISS
Intervention
- Drug: Somapacitan
Primary outcomes
what the primary-completion date above is the date OFNumber of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26
measured From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26
measured From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26
measured From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26
measured From baseline (Week 0) to Week 26
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-19 · 5.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-06-24 · 424 KB · SAP_001.pdf
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