Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Completed · Phase 2

Conditions studied: Growth Hormone Disorder, Growth Hormone Deficiency in Children

In brief

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.

Key facts

Study ID

NCT02616562

Run by

Novo Nordisk A/S

People needed

76

Starts

2016-03-31

Expected to finish

2024-09-26

Last updated by the study team

2026-01-16

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2 years and 26 weeks and below or equal to 10.0 years at screening
• Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening
• Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to screening as determined by two different GH (growth hormone) stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test is needed
• No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment
• Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender according to the standards of Centers for Disease Control and Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC at screening
• Annualized height velocity (HV) below the 25th percentile for CA (chronological age) and gender or below -0.7 SD (standard deviation) score for CA and sex, according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months

You may not qualify if…

• Any clinically significant abnormality likely to affect growth or the ability to evaluate
• growth with standing measurements: Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors. Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
• Children born small for gestational age (SGA - birth weight and/or birth length below-2 SD for gestational age)
• Concomitant administration of other treatments that may have an effect on growth, including but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
• Prior history or presence of malignancy and/or intracranial tumour

Where it is running

• Children's Hospital Los Angeles - Endocrinology — Los Angeles, California, United States
• Mattel Children's Hospital at UCLA — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Novo Nordisk Clinical Trial Call Center — San Diego, California, United States
• The Regents of the Univ of CA — San Diego, California, 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
• The Endocrine Center — Pembroke Pines, Florida, United States
• Childrens Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital For Children — Indianapolis, Indiana, United States
• Novo Nordisk Clinical Trial Call Center — Minneapolis, Minnesota, United States
• University of Minnesota_Minneapolis_2 — Minneapolis, Minnesota, United States
• Goryeb Children's Hospital — Morristown, New Jersey, United States
• Novo Nordisk Clinical Trial Call Center — Morristown, New Jersey, United States
• Rutgers-Rwjms — New Brunswick, New Jersey, United States
• UBMD Peds-Div of Endo/Diabetes — Buffalo, New York, United States
• Novo Nordisk Clinical Trial Call Center — Mineola, New York, United States
• NYU Langone Hospital-LI — Mineola, New York, United States
• CCHMC_Cinc — Cincinnati, Ohio, United States
• Novo Nordisk Clinical Trial Call Center — Cincinnati, Ohio, United States
• University Of Oklahoma-Tulsa — Tulsa, Oklahoma, United States
• Dell Pediatric Research Institute — Austin, Texas, United States
• Endocrine Associates Of Dallas — Plano, Texas, United States
• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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