CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 62 enrolled / 62 target
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/NCT03878446
NCT03878446Phase 2ActiveUpdate Overdue (0.7/mo)Completion was 61mo ago
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A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older

Novo Nordisk A/S·interventional·Posted Mar 18, 2019·Updated Jun 10, 2026

In Brief

A Phase 2 clinical trial evaluating Somapacitan and Norditropin® for Short Stature Children Born Small for Gestational Age (SGA). Active but no longer recruiting, targeting 62 participants across 95 sites in 23 countries.

Signals

Enrollment appears stalled

Detailed Summary

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Stature Children Born Small for Gestational Age (SGA)
CountriesAlgeria, Austria, Canada, Denmark, Estonia, France, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Norway, Poland, Russia, Serbia, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedMar 18, 2019
Enrollment StartJul 4, 2019
Primary CompletionMay 5, 2021
Study CompletionDec 23, 2026
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.3 years ago

Arms & Interventions

Somapacitan 0.24 mg/kg/weekexperimental

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Somapacitan
Somapacitan 0.20 mg/kg/weekexperimental

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Somapacitan
Somapacitan 0.16 mg/kg/weekexperimental

Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Somapacitan
Norditropin® 0.035 mg/kg/dayactive_comparator

Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Norditropin®
Norditropin® 0.067 mg/kg/dayactive_comparator

Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.

Drug: Norditropin®

Interventions

Somapacitandrug

Somapacitan injected under the skin once a week.

Norditropin®drug

Norditropin® injected under the skin once a day.