Sogroya (somapacitan) / Novo Nordisk - LARVOL DELTA

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

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

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

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

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

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

Safety Profile of Large IGF-1 Fluctuations: Long-Acting Growth Hormone Therapy vs. Daily Growth Hormone Therapy (ESPE-ESE 2025) - "Material and A comprehensive review of studies was conducted comparing safety profiles between long-acting GH therapies (e.g., somapacitan, TransCon GH) and daily GH therapies (e.g., Genotropin). Long-acting GH therapy is a safe and effective alternative to daily GH therapy, despite larger IGF-1 fluctuations. Careful dose titration and regular monitoring are essential to minimize transient IGF-1 SDS excursions and maintain a favorable safety profile."

Clinical • Diabetes • Growth Hormone Deficiency • IGF1

Evaluation of features for a digital application for growth hormone therapy using perceptions gathered from patients, caregivers and healthcare professionals (ESPE-ESE 2025) - "Insights from patients, caregivers and healthcare professionals (HCPs) were gathered to inform the development of MySoConnect® for Sogroya® (Novo Nordisk Health Care AG)...Patients were current users of the Norditropin® (somatropin) FlexPro® pen (Novo Nordisk Health Care AG)...HCPs were strongly in favour of adding an automated dose-logging feature, which corresponds to a connectivity element between the injection pen and the app, to encourage app use. Insights gathered from patients, caregivers and HCPs indicate that the use of an app for GHT may support adherence to treatment, with features such as tracking height gain over time, setting reminders and accessing instructional manuals and other relevant supporting information considered beneficial."

Clinical • Cognitive Disorders

Efficacy and safety of somapacitan versus daily growth hormone at 52 weeks in patients with growth hormone deficiency: pooled analysis of the randomised REAL 3, REAL 4 and REAL 6 clinical trials (ESPE-ESE 2025) - P2, P3 | "We present outcomes from a pooled analysis of data from three clinical trials (REAL 3 [NCT02616562], REAL 4 [NCT03811535] and REAL 6 [NCT04970654]) assessing the efficacy and safety of somapacitan versus daily GH (Norditropin®, Novo Nordisk). Outcomes from a pooled analysis of REAL 3, REAL 4 and REAL 6 demonstrate similar efficacy of somapacitan compared to daily GH over 52 weeks of treatment, with comparable safety and mean IGF-I SDS change in treatment-naïve children with GHD."

Retrospective data • Endocrine Disorders • Growth Hormone Deficiency • IGF1

MySoConnect® for Sogroya®: long-acting growth hormone for patients with growth-related disorders and their caregivers (ESPE-ESE 2025) - "This connected system will allow its users to set and maintain an injection routine, have continuous access to training and support related to GHT, and record and track various elements of their treatment journey over time. MySoConnect® for Sogroya® may support its users in maintaining adherence."

Clinical • Endocrine Disorders • Growth Hormone Deficiency

Efficacy of somapacitan in treatment-fatigue adults with growth hormone deficiency previously treated with daily GH injections: a 24-week randomized active-controlled trial (ESPE-ESE 2025) - "In the treatment fatigue patients with AGHD, somapacitan was reported to be more convenient than daily GH with better self-reported adherence. The changes in body composition, glucose, lipid and vascular parameters were similar in both groups. A small decrease in BMD when switching to somapacitan may reflect an initial favourable increase in the number of bone metabolic units."

Clinical • Endocrine Disorders • Fatigue • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • IGF1

Long-term efficacy and safety of once-weekly somapacitan in children with growth hormone deficiency: 7-year results from the randomised REAL 3 trial (ESPE-ESE 2025) - No abstract available

Clinical • Endocrine Disorders • Growth Hormone Deficiency