Sogroya (somapacitan) / Novo Nordisk - LARVOL DELTA

Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial. (PubMed, Eur J Endocrinol) - P3 | "Somapacitan provides similar efficacy, safety, and tolerability as daily GH in short children born SGA after 52 weeks of treatment. Somapacitan may be an attractive alternative to daily GH in this population, reducing treatment burden to improve adherence and treatment outcomes."

Journal • P3 data • Growth Hormone Deficiency • Small for Gestational Age

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

Long-Acting Growth Hormone for Treating Growth Hormone Deficiency in Children: A Meta-Analysis of Randomized Controlled Trials Focusing on Changes in Body Mass Index. (PubMed, J Clin Endocrinol Metab) - "An increase in body mass index SD score is associated with the first year of LAGH use."

Journal • Retrospective data • Endocrine Disorders • Growth Hormone Deficiency

BUDGET IMPACT MODEL OF LONAPEGSOMATROPIN FOR THE TREATMENT OF ADULT GROWTH HORMONE DEFICIENCY IN THE UNITED STATES (ISPOR 2026) - "Lonapegsomatropin is budget‑neutral to budget‑favorable during the 5-year period investigated, when replacing somapacitan. These findings support the economic viability of expanding the indication for lonapegsomatropin to AGHD. Future work should incorporate net prices/rebates and treatment‑specific utilization linked to persistence/adherence to refine payer‑relevant estimates."

Clinical • HEOR • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric)

Once-weekly Somapacitan in Children with Noonan Syndrome: Randomised Controlled Phase 3 Trial. (PubMed, Eur J Endocrinol) - P3 | "Once-weekly somapacitan was confirmed as non-inferior and demonstrated superiority to daily GH in HV after 52 weeks of treatment in treatment-naïve children living with Noonan syndrome. Similar safety profiles and tolerability were observed for both groups."

Journal • P3 data • Genetic Disorders • Growth Hormone Deficiency

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

Novo Nordisk also submitted a supplemental application for Sogroya for approval in the US for Turner Syndrome (Novo Nordisk Press Release) - "A decision is expected later this year."

FDA approval • FDA filing • Turners Syndrome

FDA approves Novo Nordisk's Sogroya as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications (Novo Nordisk Press Release) - "Sogroya is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD)....REAL8, the pivotal study for these approvals, contained three sub studies that achieved their primary endpoint, demonstrating that once-weekly Sogroya (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg was non-inferior to once-daily growth hormone treatment..."

FDA approval • Developmental Disorders • Growth Hormone Deficiency • Idiopathic Short Stature • Small for Gestational Age

Somapacitan in children with idiopathic short stature: a randomised controlled phase 3 study. (PubMed, Eur J Endocrinol) - P3 | "Similar efficacy and safety were confirmed for once-weekly somapacitan versus daily GH in treatment-naïve children with ISS, with favourable patient-reported outcome (PRO) measures, setting the ground for future treatment for ISS with a once-weekly option."

Journal • P3 data • Growth Hormone Deficiency • Idiopathic Short Stature

Growth Hormone for the Treatment of Gastroparesis (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Mayo Clinic | Trial primary completion date: Oct 2026 ➔ Oct 2027

Trial primary completion date • Gastrointestinal Disorder

Somapacitan in Children Born Small for Gestational Age: 4-year Results from Phase 2. (PubMed, Eur J Endocrinol) - P2 | "These results support long-term continuous efficacy, safety, and tolerability of GH therapy with somapacitan 0.24 mg/kg/week for up to four years in children born SGA, including after switching from daily GH."

Journal • P2 data • Small for Gestational Age

Distinct Glucose Profiles with Daily and Weekly Growth Hormone Therapy Revealed by Continuous Glucose Monitoring. (PubMed, J Endocr Soc) - "After switching to somapacitan, the time below range tended to decrease across all days. The switch from somatropin to somapacitan resulted in increased interday glucose variability, characterized by biphasic glucose fluctuations, suggesting a unique physiological effect of somapacitan on glucose profiles."

Journal • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Metabolic Disorders • IGF1

Seven-year Safety and Efficacy of Somapacitan in Children With GH Deficiency: Final Results From REAL 3. (PubMed, J Endocr Soc) - P2 | "After 7 years of treatment, children with GHD receiving somapacitan experienced consistent increases in height SDS and reduced treatment burden. No new safety concerns were identified."

Journal • Endocrine Disorders • Growth Hormone Deficiency • IGF1

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

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