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A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow | Clinical Trials | Clareo Health

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A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

A Study Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® as Well as Evaluating Long-term Safety of Somapacitan in a Basket Study Design in Children With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome, or Idiopathic Short Stature

NCT05330325•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.

Eligibility

Age

2 - 10 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed consent of parent or legally acceptable representative of participant and child assent, as age appropriate must be obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
•2. No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
•Applicable to children with SGA:
•3. Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
•4. Prepubertal children:
•1. Boys:
•* Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
•* Testis volume below 4 mL
•2. Girls:
•* Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
+43 more criteria

Exclusion Criteria

•1. Known or suspected hypersensitivity to study intervention(s) or related products.
•2. Previous randomization into same sub-study in this study.
•3. Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical study at the time of randomization.
•4. Children with suspected or confirmed growth hormone deficiency according to local practice.
•5. laboratory of
•1. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or
•2. HbA1c above or equal to 6.5%.
•6. Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
•7. Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.
•8. Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
+32 more criteria

Locations (199)

Univ of AL at Birmingham_BRM

Birmingham, Alabama, United States

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States

Sutter Valley Med Fdt Ped Endo

Sacramento, California, United States

Rady Childrens Hosp San Diego

San Diego, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Rocky Mt Ped and Endo

Centennial, Colorado, United States

Ped Endo Assoc PC-G.V

Greenwood Village, Colorado, United States

Nemours/AI duPont Hosp-Chld

Wilmington, Delaware, United States

Childrens National Medical Ctr

Washington D.C., District of Columbia, United States

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, United States

Key Dates

Start Date

August 10, 2022

Primary Completion Date

August 5, 2024

Completion Date

October 29, 2027

Last Updated

March 13, 2026

Enrollment

412

ACTUAL participants

Conditions

SGA, Turner Syndrome, Noonan Syndrome, ISS

Interventions

Somapacitan

DRUG

Norditropin®

DRUG