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A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 | Clinical Trials | Clareo Health

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A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature

NCT05723835•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.

Eligibility

Age

10 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Applicable to children with SGA:
•Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
•Age:
•\- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
•\- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
•Open epiphyses; defined as bone age less than (\<) 14 years for females and bone age \< 16 years for males.
•For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
•Applicable to children with TS:
•Diagnosis of TS according to local clinical practice.
•Age:
+19 more criteria

Exclusion Criteria

•Children with suspected or confirmed growth hormone deficiency according to local practice.
•Children diagnosed with diabetes mellitus or screening values from the central laboratory.
•Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) \[7.0 millimoles per litre (mmol/L)\] or
•Glycated hemoglobin (HbA1c) above or equal to 6.5%.
•Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
•Children requiring inhaled glucocorticoid therapy at a dose greater than 400 micrograms per day (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.
•History or known presence of malignancy including intracranial tumours.
•Applicable to children with SGA:
•Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
•Poorly controlled or uncontrolled hormonal deficiencies.
+22 more criteria

Locations (17)

Univ of AL at Birmingham_BRM

Birmingham, Alabama, United States

Sutter Valley Med Fdt Ped Endo

Sacramento, California, United States

Rocky Mt Ped and Endo

Centennial, Colorado, United States

Childrens National Medical Ctr

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

Rocky Mt Clin Res, LLC

Idaho Falls, Idaho, United States

Children's Minnesota

Saint Paul, Minnesota, United States

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

University Technology MARA (UiTM) - Sg Buloh

Bandar Puncak Alam, Selangor, Malaysia

Erasmus MC

Rotterdam, Netherlands

Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, Poland

Key Dates

Start Date

February 1, 2023

Primary Completion Date

June 7, 2024

Completion Date

October 29, 2027

Last Updated

November 21, 2025

Enrollment

ACTUAL participants

Conditions

SGATurner SyndromeNoonan SyndromeISS

Interventions

Somapacitan

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGNA

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

NCT05361811

Neurofibromatosis 1Noonan Syndrome+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

Familial Investigations of Childhood Cancer Predisposition

Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome

Cardiopulmonary Exercise Testing in Girls (8-18y) with Turner Sydrome.

MEK Inhibitors for the Treatment of Hypertrophic Cardiomyopathy in Patients With RASopathies