CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Somapacitan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03811535
NCT03811535Phase 3Completed
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A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

Novo Nordisk A/S·interventional·Posted Jan 22, 2019·Updated May 22, 2026

In Brief

A Phase 3 clinical trial evaluating Somapacitan and Norditropin® for Growth Hormone Deficiency in Children. Completed, enrolled 200 participants across 135 sites in 26 countries.

Detailed Summary

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency in Children
CountriesAlgeria, Austria, Canada, Denmark, Estonia, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Norway, Poland, Russia, Serbia, Slovenia, South Korea, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 22, 2019
Enrollment StartMay 20, 2019
Primary CompletionNov 10, 2021
Study CompletionSep 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.4 years ago

Interventions

Somapacitandrug

Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

Norditropin®drug

Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.