Norditropin (somatropin) / Novo Nordisk - LARVOL DELTA

GB06 Phase III Trial for Pediatric Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=192 | Recruiting | Sponsor: Kexing Biopharm Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

ASND0047: A Phase 3 Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children with Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders (clinicaltrialsregister.eu) - P2/3 | N=66 | Recruiting | Sponsor: Ascendis Pharma Endocrinology Division A/S

New P2/3 trial • Pan tumor • Genetic Disorders • Idiopathic Short Stature • Small for Gestational Age • Turners Syndrome • IGF1

ASND0047: A Phase 3 Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children with Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders (clinicaltrialsregister.eu) - P2/3 | N=66 | Recruiting | Sponsor: Ascendis Pharma Endocrinology Division A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Genetic Disorders • Idiopathic Short Stature • Small for Gestational Age • Turners Syndrome • IGF1

Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Jul 2026 ➔ Jul 2027 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult)

COST-EFFECTIVENESS OF CONNECTED INJECTION DEVICE FOR PEDIATRIC GROWTH HORMONE DEFICIENCY IN ARGENTINA: A SCENARIO-BASED MICROSIMULATION ANALYSIS USING REAL-WORLD DATA (ISPOR 2026) - "OBJECTIVES: To evaluate the cost-effectiveness of the connected electronic device, Easypod®, for recombinant human growth hormone, compared to Genotropin and Norditropin, non-connected devices, in the treatment of pediatric growth hormone deficiency (GHD) in Argentina... In Argentina, Easypod® has proven to be a viable option for managing pediatric GHD with real-time monitoring improving outcomes and lowering cost per cm of height gained. Early initiation and sustained adherence drive effectiveness. These findings support broader adoption of innovative digital devices to optimize care."

Clinical • Cost effectiveness • HEOR • Real-world • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

Once-weekly somapacitan vs. daily norditropin in GHD: a systematic review and meta-analysis of efficacy and safety in children and adults. (PubMed, Endocrine) - No abstract available

Journal • Retrospective data • Review • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

GB06 Phase III Trial for Pediatric Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=192 | Not yet recruiting | Sponsor: Kexing Biopharm Co., Ltd.

New P3 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD) (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Trial completion date: Apr 2026 ➔ Nov 2026 | Trial primary completion date: Apr 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • IGF1

Periconceptional GLP-1 receptor agonist exposure and obstetric outcomes: a Danish nationwide cohort study. (PubMed, Hum Reprod Open) - "The results are compatible with the hypothesis that diabetes-related factors, rather than GLP-1 receptor agonist exposure itself, may contribute to the increased preterm birth risk. If so, there are important implications for preconception counselling and may inform future guidelines for GLP-1 receptor agonist use in reproductive-age women."

Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Obstetrics • Type 2 Diabetes Mellitus

Patient and Caregiver Preferences for Once-Weekly Injection Devices for the Treatment of Growth Hormone Deficiency. (PubMed, J Endocr Soc) - "The profile similar to somapacitan-beco had the highest predicted choice probability (82%) compared with the profiles similar to lonapegsomatropin-tcgd (16%) and somatrogon-ghla (2%). Understanding patient and caregiver preferences for LA-GHA devices with less injection pain and greater ease of use highlights the value of shared decision-making, potentially leading to better treatment adherence and subsequent clinical outcomes."

Journal • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Pain

ASND0047: A Phase 3 Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children with Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders (clinicaltrialsregister.eu) - P2/3 | N=14 | Not yet recruiting | Sponsor: Ascendis Pharma Endocrinology Division A/S

New P2/3 trial • Pan tumor • Genetic Disorders • Idiopathic Short Stature • Small for Gestational Age • Turners Syndrome • IGF1

Misdiagnosed Mosaic Turner Case (XY pozitive) (ISGE 2026) - "After the karyotype result was 45X0 (Classic form TS), Growth Hormone (GH) therapy (Norditropin) was initiated...Laboratory: morning fasting cortisol 15.1 ng/L (normal), ACTH 17.3 pg/mL (normal), DHEA-S 147.5 µg/dL (normal), 17-OH Progesterone 0.1 ng/mL (normal), Total testosterone 1.07 ng/mL (high for a 12-year-old girl, normal for a boy)... Patients with TS most often consult a physician during childhood due to short stature. In girls presenting with short stature, TS must definitely be considered, and if there are other accompanying symptoms characteristic of this syndrome, karyotype determination must certainly be requested. If the clinical picture is not fully explained by the classic TS genotype and doubt remains, the less common genetic variants of TS and other diseases that may cause the same clinical picture should be considered for the patient's future quality of life and proper management of the disease; if there is a clinical-laboratory..."

Clinical • Congenital Adrenal Hyperplasia • Endocrine Disorders • Genetic Disorders • Turners Syndrome • Women's Health

A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD) (clinicaltrials.gov) - P1/2 | N=128 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1/2 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS) (clinicaltrials.gov) - P1/2 | N=128 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New P1/2 trial • Idiopathic Short Stature

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=188 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P3 trial • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=200 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=200 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Dec 2024 ➔ Sep 2025

Real-world evidence • Trial completion date • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=192 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Trial primary completion date: Jun 2021 ➔ Nov 2021

Real-world evidence • Trial primary completion date • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=192 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=192 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Jul 2024 ➔ Oct 2024

Real-world evidence • Trial completion date • Endocrine Disorders • Growth Hormone Deficiency • IGF1

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (clinicaltrials.gov) - P3 | N=192 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Long-term effectiveness and safety of daily growth hormone therapy in Japanese children with Noonan syndrome: a post-marketing surveillance study. (PubMed, Endocr J) - P=N/A, P3 | "Our results show that Norditropin® effectively improved height outcomes in Japanese children with NS and was well tolerated with no new safety issues identified. For patients with NS and cardiomyopathy receiving GH therapy, careful monitoring is advised."

Journal • P4 data • Cardiomyopathy • Cardiovascular • Genetic Disorders

Skeletal Muscle Effects of GH in Boys (clinicaltrials.gov) - P=N/A | N=45 | Completed | Sponsor: Nemours Children's Clinic | Active, not recruiting ➔ Completed

Trial completion • Endocrine Disorders • Growth Hormone Deficiency • Idiopathic Short Stature

Skeletal Muscle Effects of GH in Boys (clinicaltrials.gov) - P=N/A | N=45 | Active, not recruiting | Sponsor: Nemours Children's Clinic | Trial completion date: Jul 2025 ➔ Oct 2025

Trial completion date • Endocrine Disorders • Growth Hormone Deficiency • Idiopathic Short Stature

Comparative Outcomes of GH Treatment in Pediatric Idiopathic Short Stature and GH Deficiency. (PubMed, J Endocr Soc) - "This post hoc analysis of the NordiNet International Outcome Study (2006-2016) and the American Norditropin Studies: Web-Enabled Research Program (2002-2016) included children with ISS or GHD who initiated treatment aged <18 years...Incidence of adverse reactions was similar across indications, with no new safety signals. GH treatment over 5 to 10 years effectively increased height in children with ISS and children with GHD, including those who reached NAH, with a favorable benefit-risk profile."

Journal • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Idiopathic Short Stature • Pediatrics