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

NCT02616562 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: NN8640-41722015-000531-32U1111-1166-7062
• Study Type: interventional
• Target: 76
• Locations: 14 countries
• Sites: 89

Brief Summary

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.

Conditions

Growth Hormone Disorder; Growth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (2)

• Height Velocity (HV) (cm/Year) During the First 26 Weeks of Treatment, Measured as Standing Height With Stadiometer

  Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).

  Baseline (week 0), week 26

• Cohort II and Cohort III - Adverse Events Rate, Including Injection Site Reactions in Children With GHD.

  This primary outcome measure was analysed by cohort using descriptive statistics. Adverse event per 100 patient years are presented in this outcome measure.

  From week 156 up to week 364

Secondary Outcomes (12)

• Cohort I: Change in Height Standard Deviation Score (HSDS)

  Baseline (Week 0), week 26, week 52

• Cohort I: Change in Height Velocity Standard Deviation Score (HVSDS)

  Baseline (Week 0), week 26, week 52

• Cohort I: Adverse Events Rate, Including Injection Site Reactions

  From week 0 Up to week 364

• Cohort I: Occurrence of Anti-NNC0195-0092 and Anti-hGH Antibodies

  From week 0 Up to week 364

• Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)

  (Week 0), week 26, week 52

Study Arms (5)

Cohort I Norditropin/somapacitan

EXPERIMENTAL

Participants received Norditropin subcutaneously daily in main trial period, extension trial period and safety extension trial period. After completing the safety extension trial period (week 156), participants who received Norditropin were allocated to open-labelled Somapacitan dose 3 subcutaneously once weekly for the 208-week (up till week 364) long-term safety extension period. After week 364, participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.

Drug: somapacitan; Drug: Norditropin® FlexPro® pen

Cohort I somapacitan pooled

EXPERIMENTAL

Participants were randomized (1:1:1) to receive Somapacitan treatment (dose 1/dose 2/dose 3) subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), all participants initially randomized to double-blinded Somapacitan received open-labelled Somapacitan dose 3 for the 104-week safety extension trial period. After completing the safety extension trial period (week 156), all participants in cohort I were allocated to open-labelled somapacitan dose 3 for the 208-week (up till week 364) long-term safety extension period. In extension after week 364 period participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest.

Drug: somapacitan

Cohort II somapacitan previously treated

EXPERIMENTAL

Participant who was previously treated with GH (Growth hormone) prior to enrollment in the trial at week 156, received somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.

Drug: somapacitan

Cohort III somapacitan treatment naive

EXPERIMENTAL

Participants who were naive to treatment with GH prior to enrolment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.

Drug: somapacitan

Cohort III somapacitan previously treated

EXPERIMENTAL

Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest.

Drug: somapacitan

Interventions

somapacitan DRUG

Administered subcutaneously (s.c., under the skin) once-weekly.

Also known as: NNC0195-0092

Cohort I Norditropin/somapacitan; Cohort I somapacitan pooled; Cohort II somapacitan previously treated; Cohort III somapacitan previously treated; Cohort III somapacitan treatment naive

Norditropin® FlexPro® pen DRUG

Administered subcutaneously (s.c., under the skin) once daily.

Cohort I Norditropin/somapacitan

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (89)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, 90027, United States

Location

Mattel Children's Hospital at UCLA

Los Angeles, California, 90095, United States

Location

Valley Children's Hospital

Madera, California, 93636-8762, United States

Location

Novo Nordisk Clinical Trial Call Center

San Diego, California, 92123, United States

Location

The Regents of the Univ of CA

San Diego, California, 92123, United States

Location

Rocky Mt Ped and Endo

Centennial, Colorado, 80112, United States

Location

Ped Endo Assoc PC-G.V

Greenwood Village, Colorado, 80111-2803, United States

Location

Nemours/AI duPont Hosp-Chld

Wilmington, Delaware, 19803, United States

Location

The Endocrine Center

Pembroke Pines, Florida, 33028, United States

Location

Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Riley Hospital For Children

Indianapolis, Indiana, 46202, United States

Location

Novo Nordisk Clinical Trial Call Center

Minneapolis, Minnesota, 55454, United States

Location

University of Minnesota_Minneapolis_2

Minneapolis, Minnesota, 55454, United States

Location

Goryeb Children's Hospital

Morristown, New Jersey, 07962, United States

Location

Novo Nordisk Clinical Trial Call Center

Morristown, New Jersey, 07962, United States

Location

Rutgers-Rwjms

New Brunswick, New Jersey, 08901, United States

Location

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, 14203, United States

Location

Novo Nordisk Clinical Trial Call Center

Mineola, New York, 11501, United States

Location

NYU Langone Hospital-LI

Mineola, New York, 11501, United States

Location

CCHMC_Cinc

Cincinnati, Ohio, 45229, United States

Location

Novo Nordisk Clinical Trial Call Center

Cincinnati, Ohio, 45229, United States

Location

University Of Oklahoma-Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Dell Pediatric Research Institute

Austin, Texas, 78723, United States

Location

Endocrine Associates Of Dallas

Plano, Texas, 75093, United States

Location

Children's Hsptl Of The Kings

Norfolk, Virginia, 23507, United States

Location

MultiCare Inst for Res & Innov

Tacoma, Washington, 98405, United States

Location

Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)

Linz, Upper Austria, 4020, Austria

Location

Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie

Graz, 8036, Austria

Location

Unknown Facility

Graz, 8036, Austria

Location

LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde

Salzburg, 5020, Austria

Location

LKH St. Poelten, Kinder-und Jugendheilkunde

Sankt Pölten, 3100, Austria

Location

Landeskrankenhaus Villach

Villach, 9500, Austria

Location

Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, 4840, Austria

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Unknown Facility

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

Brussels, 1200, Belgium

Location

UZ Leuven - Kindergeneeskunde

Leuven, 3000, Belgium

Location

CHU de Liège, site N.-D. des Bruyères

Liège, 4030, Belgium

Location

Serviço de Endocrinologia e Metabologia do HC-UFPR

Curitiba, Paraná, 80030-110, Brazil

Location

Hospital São Lucas - PUC/RS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01228-000, Brazil

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Centre Hospitalier Universitaire D'Angers-2

Angers, 49033, France

Location

Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

Bordeaux, 33076, France

Location

Unknown Facility

Bordeaux, 33076, France

Location

Centre Hospitalier Universitaire de Nantes-Hopital Enfant-Adolescent

Nantes, 44000, France

Location

Ap-Hp-Hopital Necker

Paris, 75015, France

Location

HOPITAL SUD de RENNES

Rennes, 35056, France

Location

HOPITAL DES ENFANTS-HOPITAL PAULE DE VIGUIER - Pharmacie

Toulouse, 31059, France

Location

Unknown Facility

Frankfurt, 60596, Germany

Location

Endokrinologikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)

Ulm, 89075, Germany

Location

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

Jehangir Clinical Development Centre

Pune, Maharashtra, 411001, India

Location

All India Institute of Medical Sciences

New Dehli, New Delhi, 110029, India

Location

Unknown Facility

New Dehli, New Delhi, 110029, India

Location

Soroka MC - Pediatric Endocrinology

Beersheba, 84101, Israel

Location

Rambam MC - Department of Pediatrics A

Haifa, 31096, Israel

Location

Meir MC - Department of Paediatrics

Kfar Saba, 44281, Israel

Location

Unknown Facility

Kfar Saba, 44281, Israel

Location

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, 49202, Israel

Location

Sheba MC - Pediatric endocrinology and adolescent diabetes clinics

Tel Litwinsky, 52621, Israel

Location

Kyushu Univ. HP, Maternity & Perinatal Care Center

Fukuoka, 812-8582, Japan

Location

Kurume University Hospital, Pediatrics

Fukuoka, 830-0011, Japan

Location

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, 216-8511, Japan

Location

Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics

Kyoto, 602-8566, Japan

Location

Osaka City General Hospital, Pediatric Endocrinology and Me

Osaka, 534-0021, Japan

Location

JCHO Osaka Hospital_Pediatric

Osaka, 553-0003, Japan

Location

Osaka Women's and Children's Hospital

Osaka, 594-1101, Japan

Location

Institute of Science Tokyo Hospital_Pediatrics

Tokyo, 113-8519, Japan

Location

Tokyo Medical and Dental University Hospital

Tokyo, 113-8519, Japan

Location

National Center for Child Health and Dev, Endo and Metabo

Tokyo, 157 8535, Japan

Location

Unknown Facility

Tokyo, 157 8535, Japan

Location

University Children's Hospital

Ljubljana, 1525, Slovenia

Location

Unknown Facility

Ljubljana, 1525, Slovenia

Location

Astrid Lindgrens Barnsjukhus

Stockholm, 171 76, Sweden

Location

Unknown Facility

Stockholm, 171 76, Sweden

Location

Barn och ungdomscentrum Västerbotten

Umeå, 901 85, Sweden

Location

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

Adana, 01130, Turkey (Türkiye)

Location

Hacettepe Üniversitesi Hastanesi- Endokrinoloji

Ankara, 06230, Turkey (Türkiye)

Location

I.U Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34093, Turkey (Türkiye)

Location

Marmara University Medical Faculty

Istanbul, 34854, Turkey (Türkiye)

Location

Marmara Üniversitesi Pendik EAH- Başıbüyük Yerleşkesi- Kardiyoloji

Istanbul, 34854, Turkey (Türkiye)

Location

Ivano-Frankivsk Regional Clinical Children Hospital - Endocrinology dept.

Ivano-Frankivsk, 76018, Ukraine

Location

Unknown Facility

Kiev, 04114, Ukraine

Location

Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology

Kyiv, 04114, Ukraine

Location

Related Publications (3)

• Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Rohrich S, Saenger P, Horikawa R. Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2569-2578. doi: 10.1210/clinem/dgad183.

  PMID: 36995872 DERIVED

• Savendahl L, Battelino T, Hojby Rasmussen M, Brod M, Saenger P, Horikawa R. Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1357-1367. doi: 10.1210/clinem/dgab928.

  PMID: 34964458 DERIVED

• Savendahl L, Battelino T, Brod M, Hojby Rasmussen M, Horikawa R, Juul RV, Saenger P; REAL 3 study group. Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1847-61. doi: 10.1210/clinem/dgz310.

  PMID: 31917835 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

somapacitan; NNC0195-0092

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: November 30, 2015
• Study Start: March 31, 2016
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

SL (2); SE (3); JP (11); TU (6); UA (3); DE (3); IN (4); AU (7); BR (4); CA (1); BE (5); US (27); IL (6); FR (7)