Sogroya (somapacitan) / Novo Nordisk - LARVOL DELTA

Safety and efficacy of somapacitan in adults with growth hormone deficiency who were switched from daily growth hormone therapy: A systematic review and meta-analysis. (PubMed, Growth Horm IGF Res) - "Somapacitan is as effective as daily GH in treating adults with GHD, with a reasonable safety profile and modest benefits for glucose homeostasis, as well as treatment convenience."

Journal • Retrospective data • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • IGF1

A pharmacological profile of somapacitan for the treatment of growth hormone deficiency. (PubMed, Expert Rev Clin Pharmacol) - "Continued somapacitan therapy in clinical trials in children with GHD has shown ongoing catch-up growth while having a similar safety profile to daily growth hormone. However, it will be important to capture real world data demonstrating ongoing safety, efficacy and adherence in children and adults receiving somapacitan and other LAGH therapies."

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

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

Long-acting GH Use in Patients With Adult GH Deficiency Coexisting With Type 1 Diabetes Mellitus. (PubMed, JCEM Case Rep) - "This report provides insights into the metabolic effects of GH fluctuations in T1DM and the potential impact of somapacitan on insulin sensitivity. Further studies are warranted to establish optimal GH dosing strategies for patients with diabetes undergoing GH replacement therapy."

Journal • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Budget impact analysis of Skytrofa for the treatment of pediatric growth hormone deficiency in a US health plan. (PubMed, J Med Econ) - "This analysis included daily somatropin, and weekly somatrogon and somapacitan, as comparators. The primary drivers of the cost reduction were decreased acquisition costs for daily somatropin and the elimination of wastage for weekly GHs. The inclusion of lonapegsomatropin in the formulary of a US health plan can result in a significant reduction in total costs for the plan."

HEOR • Journal • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

Administration study of somapacitan, a long-acting growth hormone derivative, in horse for doping control purpose. (PubMed, Growth Horm IGF Res) - "The somapacitan-specific T10 peptide fragment that allows discriminative identification of somapacitan and rhGH was detected up to 14 days and confirmed in post-administration samples collected up to 10 days. Several shared peptide fragments between somapacitan and rhGH were also detected and confirmed in plasma samples collected 14 days post-administration, supporting the applicability of the test strategy for the analysis of authentic doping control samples in horses."

Journal • IGF1

Efficacy And Safety Of Somapacitan In Non-GHD Adolescents With Short Stature: 26-week Results From The REAL9 Phase 3 Study (ENDO 2025) - P3 | "In conclusion, 26-weeks of treatment with somapacitan showed a safety and tolerability profile in older children and adolescents across all four indications (SGA, TS, NS, and ISS) similar to younger children. In addition, somapacitan effectively improved longitudinal growth in treatment-naïve participants and maintained growth in participants previously treated with daily GH."

Clinical • Late-breaking abstract • P3 data • Genetic Disorders • Idiopathic Short Stature • Pain • Small for Gestational Age • Turners Syndrome • IGF1

Long-term Safety And Efficacy Of Somapacitan In Short Children Born Small For Gestational Age: 4-year Results From A Global Phase 2 Trial (ENDO 2025) - P2 | "In conclusion, these data support long-term efficacy, safety, and tolerability of once-weekly somapacitan in short children born SGA with up to 4 years of treatment. A clear preference for once-weekly somapacitan was observed."

Clinical • Late-breaking abstract • P2 data • Diabetes • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Metabolic Disorders • Pain • Pediatrics • Small for Gestational Age • Type 1 Diabetes Mellitus

Acutely regulated genes in children born small for gestational age following daily and weekly growth hormone are predictive of first-year growth response (ENDO 2025) - P2 | "Our results suggest that fast response is potentially more strongly associated with acute regulation of response to GH, and that coordinated gene expression implies common GH responses for daily GH and somapacitan."

Clinical • Growth Hormone Deficiency • Small for Gestational Age

Reduced high-sensitivity C-reactive protein levels following weekly somapacitan in adults with growth hormone deficiency: a prospective pilot study. (PubMed, J Endocrinol Invest) - "The reduction in hs-CRP levels after somapacitan therapy for GHD suggests that somapacitan has a protective role against inflammation, possibly mediated by the liver."

Journal • Atherosclerosis • Cardiovascular • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Inflammation • CRP • IGF1

First 100 patients receiving long-acting growth hormone therapy: real-world evaluation from INSIGHTS-GHT registry. (PubMed, Orphanet J Rare Dis) - "Following the market launch of three LAGH products in Germany (lonapegsomatropin, somapacitan, and somatrogon) we aimed to provide early real-world evidence on their use in order to obtain an initial picture on patient selection and physician preferences outside of clinical trials.We report in this interim analysis on 70 pediatric patients from 15 centers across Germany as well as 31 adult patients from 6 German centers under LAGH treatment. More than half (55%) received the LAGH starting dose according to the manufacturer's recommendation, while 41% began with a lower-than-recommended dose. Our findings provide early insights into LAGH therapy adoption and highlight the need for continued follow-up to evaluate long-term efficacy, adherence, and safety in real-world settings."

HEOR • Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1 • IGFBP3

First Real-World Evidence Of Somapacitan Therapy Initiation In Children With GHD From GloBE-Reg (ENDO 2025) - "For the first time, RWE on children starting somapacitan for GHD are reported, offering valuable insights into their profiles. Consistent with expectations, most patients were male and around 10 years old, while baseline somapacitan dose was lower than the approved dose of 0.16 mg/kg/week. Notably, GH-naïve patients began treatment at or approaching puberty; studies suggest improved outcomes are associated with earlier treatment start."

Clinical • HEOR • Late-breaking abstract • Real-world • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • IGF1

SI01-12. Realizing the possibilities with Sogroya® (somapacitan-beco) 5, 10, or 15 mg: Real-world patient experiences and long-term clinical data (ENDO 2025) - "The Endocrine Society thanks the following supporters: Funded Novo Nordisk Healthcare AG Join us for a presentation on the long-term clinical trial data for Sogroya® (somapacitan-beco) 5, 10, or 15 mg. Following the clinical presentation, patient and caregiver ambassadors will share their stories about the journey from diagnosis to treatment and how Sogroya® has affected their lives."

Clinical data • Real-world • Real-world evidence

Daily Growth Hormone Replacement Versus Weekly Somapacitan for Growth Hormone Deficiency in Prepubertal Children: A Systematic Review and Meta-Analysis (ENDO 2025) - "Results of this systematic review and meta-analysis suggest that Somapacitan had no significant effect on IGF-I, HSDS, or total adverse events. However, a significant improvement in height velocity was observed, with Somapacitan showing greater efficacy in increasing height velocity compared to daily GH treatment."

Retrospective data • Review • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Patient and Caregiver Preferences for Once-Weekly Injection Devices for the Treatment of Growth Hormone Deficiency (ENDO 2025) - "Respondents reported a strong preference (82%) for the device profile with attribute levels resembling somapacitan-beco over other LA-GHA device profiles, which was similar for each cohort (81%-85%)...Conclusion Factors such as injection pain and convenience have the greatest impact on patient preferences for LA-GHA devices. Less pain and superior convenience may lead to better patient adherence and clinical outcomes in treating GHD."

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

Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4. (PubMed, Eur J Endocrinol) - P3 | "Sustained efficacy and tolerability were observed for continuous somapacitan treatment for 3 years, and for 2 years after the switching from daily GH treatment. HSDS in both groups was approaching mean mid-parental HSDS."

Clinical • Journal • Endocrine Disorders • Growth Hormone Deficiency • IGF1

INSIGHTS-GHT: First evaluation of paediatric patients with long-acting growth hormone therapy (LAGH) from the German registry (ESPE-ESE 2025) - "In particular, since the end of 2023, patients treated with the newly approved long-acting GH preparations (LAGH) Ngenl"

Clinical • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics • Rare Diseases

Circulating IGF-1 Levels and Trends in Response to Daily and Weekly GH Therapies: A Comparative Analysis (ESPE-ESE 2025) - " Data were synthesized from eight studies analyzing IGF-1 response to various GH therapies, including daily rGH and weekly long-acting formulations such as somapacitan, PEG-rhGH, TransCon GH, and Nutropin Depot...Daily GH Therapies: Daily rGH therapy (e.g., Genotropin, Norditropin) resulted in more consistent IGF-1 levels with minor daily fluctuations, providing a steady profile throughout the week-(Lundberg et al., 2018)... Both weekly and daily GH therapies effectively elevate IGF-1 levels, with distinct advantages and limitations. Weekly formulations optimize patient adherence and long-term exposure, whereas daily rGH ensures consistent IGF-1 profiles. Table: IGF-1 Trends and Patterns Between Daily Vs Long-Acting-GH Therapies IGF-1 Response GH Therapy Type Key IGF-1 Trends IGF-1 Patterns Consistency Variable-Timing, Stable Higher consistency across Daily GH Fluctuates-Daily Long-Term days Dose-Dependent, Higher overall AUC due to Long-Acting GH Weekly-Peaks and..."

IGF1

Growth hormone therapy demonstrates no clinical impact on thyroid function in children with growth hormone deficiency (ESPE-ESE 2025) - "Methods Three randomized, multinational, open-labeled parallel-group phase 2 (REAL3, n=59) and phase 3 (REAL4, n=200; and REAL6, n=110) trials investigated efficacy and safety of once-weekly somapacitan compared to once-daily GH (Norditropin®, Novo Nordisk) administration in treatment-naïve, prepubertal children with GHD. Clinicians can be reassured that GH therapy does not pose a significant risk of inducing hypothyroidism. Cases with central GHD warrants special attention."

Clinical • Late-breaking abstract • Endocrine Disorders • Growth Hormone Deficiency

Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial (ESPE-ESE 2025) - No abstract available

Clinical • Late-breaking abstract • P3 data • Small for Gestational Age

Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: a Randomised Phase 3 Trial (ESPE-ESE 2025) - No abstract available

Clinical • Late-breaking abstract • P3 data • Idiopathic Short Stature

Weekly Somapacitan is Effective and Well-Tolerated in Children with Noonan Syndrome: Randomised Phase 3 Trial (ESPE-ESE 2025) - P3 | "In conclusion, non-inferiority was confirmed and superiority was demonstrated for somapacitan 0.24 mg/kg/week compared to daily GH 0.050 mg/kg/day after 52 weeks of treatment in treatment-naïve children with NS. The safety profiles were similar for both groups."

Clinical • Late-breaking abstract • P3 data • Cardiomyopathy • Cardiovascular • CNS Disorders • Cognitive Disorders • Developmental Disorders • Genetic Disorders • Hypertrophic Cardiomyopathy • Psychiatry • IGF1

Model-based Analysis of IGF-I Response, Dosing, and Monitoring for Once-weekly Somapacitan in Children Born Small for Gestational Age or with Idiopathic Short Stature or Noonan Syndrome (ESPE-ESE 2025) - P1, P2, P3 | "To support IGF-I monitoring, we present a practical guide about expected weekly average IGF-I concentrations in these patients and provide insights on dosing day flexibility. The findings are consistent with previous somapacitan recommendations for children with GHD."

Clinical • Late-breaking abstract • Genetic Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Idiopathic Short Stature • Pediatrics • Small for Gestational Age • IGF1

Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial (ESPE-ESE 2025) - P3 | "No trend was seen in the amount or type of AEs reported in participants treated with somapacitan compared to daily GH. In conclusion, HV response after 52 weeks of somapacitan 0.24 mg/kg/week showed superiority to daily GH 0.035 mg/kg/day and non-inferiority to daily GH 0.067 mg/kg/day with a similar safety profile and IGF-I response in treatment-naïve children born SGA."

Clinical • Late-breaking abstract • P3 data • Pain • Small for Gestational Age • IGF1

Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: a Randomised Phase 3 Trial (ESPE-ESE 2025) - P3 | "Both groups demonstrated reduced disease burden from baseline to week 52, while treatment burden scores favoured once-weekly somapacitan over daily GH. In conclusion, somapacitan 0.24 mg/kg/week has similar efficacy and safety profiles as daily GH 0.050 mg/kg/day with similar mean IGF-I levels and favourable PROs in treatment-naïve children with ISS."

Clinical • Late-breaking abstract • P3 data • Idiopathic Short Stature • Pain • Pediatrics • IGF1