Zomacton (somatropin) / Ferring - LARVOL DELTA

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University | Trial completion date: Feb 2027 ➔ Feb 2028 | Initiation date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial initiation date • Trial primary completion date • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University | Initiation date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial initiation date • Trial primary completion date • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Human Models of Selective Insulin Resistance: Pancreatic Clamp (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Columbia University

New P1 trial • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: Northwell Health

New P3 trial • Endocrine Disorders • Growth Hormone Deficiency • IGF1 • IGFBP3

ZomaTrip: A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height (clinicaltrials.gov) - P4 | N=44 | Active, not recruiting | Sponsor: Belgian Study Group for Pediatric Endocrinology | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

Combination therapy • Trial completion date • Trial primary completion date • Idiopathic Short Stature

Investigating Thermally Induced Aggregation of Somatropin- New Insights Using Orthogonal Techniques. (PubMed, Int J Pharm) - "Smaller elongated aggregates are formed in the first step, possibly initiated by partly unfolded species. In the second step, occurring during longer heating, the smaller aggregates assemble into larger aggregates with more complex structures."

Journal

Lonapegsomatropin (Skytrofa) for growth hormone deficiency. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Endocrine Disorders • Growth Hormone Deficiency

"Elite HRT Publishes Information on Zomacton https://t.co/MflSxY38Lx" (@NewsFromBW)

Early hGH Treatment of SGA Infants to Prevent Irreversible Neurologic and Psychological Damage and Sequelae (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Tel-Aviv Sourasky Medical Center

New P2 trial • Biosimilar • Growth Hormone

ADHERENCE TO TREATMENT WITH ZOMAJET, A NEEDLE- FREE DEVICE TRANSJECTING GROWTH HORMONE: RESULTS OF A FRENCH OBSERVATIONAL SURVEY (ESPE 2017) - "This study evaluated pediatric compliance with somatropin (Zomacton™) delivered via ZomaJet needle -free devices (ZomaJet Vision X or ZomaJet 2 Vision). Subjects receiving somatropin administered via ZomaJet needle-free devices had high compliance rates and good clinical outcomes, despite some reports of poor tolerability and ISRs."

Biosimilar • Growth Hormone • Ophthalmology • Pain

RAZANT: Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome (clinicaltrials.gov) - P=N/A; N=700; Not yet recruiting; Sponsor: Ferring Pharmaceuticals; Initiation date: Feb 2018 ➔ Mar 2018

Trial initiation date • Biosimilar • Growth Hormone

Needle-Free and Needle-Based Growth Hormone Therapy in Children: A Pooled Analysis of Three Long-Term Observational Studies. (PubMed, Horm Res Paediatr) - "Real-life data show that treatment with Zomacton® improves auxological outcome parameters without new safety concerns. NF administration of GH represents a useful alternative to NI in children with growth disorders."

Journal • Observational data • Retrospective data

Improved adherence and growth outcomes with jet-delivered growth hormone. (PubMed, J Pediatr Endocrinol Metab) - "MPHSDS - HTSDS showed a similar significant improvement at 3 years in adherent patients only (p = 0.0043). Conclusions Patients adherent to JrGH demonstrate significant growth improvement compared to baseline over 3 years."

Journal