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ACTIVE NOT RECRUITING Phase 2

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

NCT03878446 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Somapacitan
  • DRUG Norditropin®

Study Locations (20)

Other

  • CHU Bab El Oued Pediatrics Dept — Algiers
  • Endo and Diab Dept El Oued — Algiers
  • endocrino-diabetology department, Hospital IBN BADIS. — Constantine
  • Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie — Graz
  • LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde — Salzburg

New York

  • NYU Langone Hospital-LI — Garden City
  • NYU Langone Hospital-LI — Mineola
  • Icahn Sch of Med-Mt Sinai Hosp — New York

Minnesota

  • Univ of Minnesota M.C.H. — Minneapolis
  • Children's Minnesota — Saint Paul

New Jersey

  • Goryeb Children's Hospital — Morristown
  • Rutgers-Rwjms — New Brunswick

Alabama

  • Univ of AL at Birmingham_BRM — Birmingham

California

  • Children's Hosp Of Orange — Orange

Idaho

  • St. Luke's Children's Endo — Boise

Ohio

  • CCHMC_Cinc — Cincinnati

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2019-07-04
Est. Completion 2026-12-23
Phase Phase 2

Sponsor

Novo Nordisk A/S

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03878446

The ClinicalTrials.gov registry entry for NCT03878446 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Short Stature Children Born Small for Gestational Age (SGA) appearing as the primary indexed condition, and to 2 interventions — of which Somapacitan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03878446 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, New York, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03878446 about?

NCT03878446 is a clinical study titled "A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day". 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 ...

What is the current status of trial NCT03878446?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2019-07-04. Estimated completion is 2026-12-23.

What conditions does trial NCT03878446 study?

This clinical trial studies the following conditions: Short Stature Children Born Small for Gestational Age (SGA). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03878446?

The interventions under investigation include: Somapacitan (DRUG), Norditropin® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03878446?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03878446 being conducted?

This trial has 20 study locations across Alabama, California, Idaho, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial