Zorbtive (somatropin) / EMD Serono - LARVOL DELTA

Differences in Age at Treatment Start of Recombinant Human Growth Hormone Therapy Among European Countries (ESPE-ESE 2025) - "Objective: This study aimed to evaluate the age at treatment start in children and adolescents with GHD treated with r-hGH therapy (Saizen®, Merck KGaA, Darmstadt, Germany) among European countries... Although these data include non-naive patients, our findings show variations in the age at treatment start across different European countries. The data suggests a delayed start of r-hGH treatment across most European countries, which has potential implications for the final height outcome. The differences may be explained by the use of different country-specific guidelines for the early detection of growth disorders and their degree of implementation, the number and timing of healthcare visits and other healthcare practices."

Endocrine Disorders • Growth Hormone Deficiency

Impact of the TUITEK™ Patient Support Program on Caregivers-Related Behaviours in Enhancing Growth Hormone Treatment Adherence (ESPE-ESE 2025) - " This prospective pre–post study of the TUITEK™ PSP was conducted in a combined population of caregivers (aged 25–60 years) of patients with short stature receiving r-hGH treatment (somatropin [Saizen®; Merck KGaA, Darmstadt, Germany]) using auto-injector device and injection pens in Argentina, the Republic of Korea, and Taiwan...** The TUITEK™ PSP successfully improved key caregiver-related behaviours that may negatively impact adherence to r-hGH treatment. Furthermore, it might improve treatment adherence and thus clinical outcomes."

Adherence • Clinical • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Mood Disorders • Pediatrics • Psychiatry

A Post Market Observational Study to Evaluate User’s Perception on Technology Acceptance and Usability of Two Generations of Digital Devices to Manage Growth Disorders Across France and Spain (ESPE-ESE 2025) - "Background: The Easypod® 3 auto-injector (Merck KGaA, Darmstadt, Germany) is the “third generation” of Easypod® (used to administer recombinant human growth hormone treatment [Saizen®, Merck KGaA, Darmstadt, Germany]) and represents a technological evolution of its predecessor Easypod® 2... This interim analysis suggests that users’ perceptions of Easypod® 3 from both technology acceptance and usability perspectives are overall positive compared to their perceptions of its predecessor Easypod® 2. The study will continue till 100 complete survey responses across both countries are received."

Clinical • Observational data • P4 data • Endocrine Disorders

Effect of rhGH treatment on lipidome and brown fat activity in prepuberal small for gestational age children: a pilot study. (PubMed, Sci Rep) - "The study involved 11 SGA children divided into two groups: (a) SGA children who were not treated with rhGH (n = 4) and (b) SGA children who received rhGH treatment with Saizen® (n = 7)...rhGH influences the serum lipidome, promoting changes in maturation and metabolism. Further research is required to clarify the direct effects of rhGH on specific lipid species and batokines, potentially addressing metabolic disturbances linked to obesity and aging."

Journal • Genetic Disorders • Metabolic Disorders • Obesity • Small for Gestational Age • CCL2 • LEP

Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial. (PubMed, Hum Reprod) - P4 | "These findings suggest that adding GH therapy to ovarian stimulation in GnRH antagonist cycles may not benefit the general IVF population. Additional high-quality RCTs are warranted to identify subgroups of patients who might benefit from this treatment."

Journal • Gynecology • Infertility • Sexual Disorders

Preferences for Injection Device Settings and the Association with Adherence to Growth Hormone Treatment in Patient with Growth Disorders. (PubMed, Stud Health Technol Inform) - "Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is important to achieve positive growth and other outcomes in children with growth disorders...A higher proportion of patients with intermediate/low adherence in the first month of treatment (31%, n=18/59) changed the device settings during treatment compared with those with high adherence (16%, n=128/803) (p=0.005). The ability to adjust injection device settings offers a valuable opportunity for personalizing treatment, improving patient comfort and treatment adherence."

Adherence • Journal • Observational data • Retrospective data • Endocrine Disorders • Mood Disorders • Psychiatry

Participatory Study to Explore Healthcare Professionals' Perceptions of a Connected Digital Solution for Adherence Monitoring of Recombinant Human Growth Hormone Treatment: Study Protocol and First Findings. (PubMed, Stud Health Technol Inform) - "Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is fundamental to achieve positive growth outcomes in children with growth disorders and to improve quality of life and cardiometabolic risk in adult patients affected by GH deficiency...Here, we present the methodology and first results of a participatory workshop that assessed clinicians' perceptions on such a digital solution - the aluetta™ smartdot™ (Merck Healthcare KGaA, Darmstadt, Germany) - combining the aluetta™ pen injector and a connected device, components of a comprehensive digital health ecosystem to support pediatric patients receiving r-hGH treatment. The aim being to highlight the importance of collecting clinically meaningful and accurate real-world adherence data to support data-driven healthcare."

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

STARFISH: Study of Testosterone and rHGH in FSHD (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: University of Rochester | Active, not recruiting ➔ Completed

Trial completion • Muscular Dystrophy • Solid Tumor • IGF1

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

Journal • Endocrine Disorders • Growth Hormone Deficiency

Adjuvant Growth Therapy in in Vitro Fertilization (clinicaltrials.gov) - P4; N=288; Completed; Sponsor: Clinique Ovo; Active, not recruiting ➔ Completed

Preclinical • Trial completion • Gynecology • Infertility • Sexual Disorders

"Dat zegt #Pfizer wel vaker, deze waren ook zogenaamd veilig en ook zelf genomen? -> #valdecoxib #prempo #softenon #serostim #oxyxontin Zullen we dezelfde berichten als voorgaande medicatie gaan lezen over de #mRNA van #Pfizer? Geschiedenis herhaald zich. https://t.co/2tJrPc0hV4" (@leijpeideaud)

[VIRTUAL] Determining factors of a good response to treatment with growth hormone for the first 2 years (ESPE 2021) - "Patients received treatment with Saizen®, allowing to assess adherence to treatment through the EasyPod Connect platform... Adherence is a determining parameter in the response to treatment with GH; a value> 90% is estimated as optimal for a better response the first year of treatment, and >85% the second. The percentage of adherence is higher in those patients with greater growth restriction at the beginning and remains high in those with higher HV."

STARFISH: Study of Testosterone and rHGH in FSHD (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: University of Rochester; Recruiting ➔ Active, not recruiting

Enrollment closed • Muscular Dystrophy • IGF1

STARFISH: Study of Testosterone and rHGH in FSHD (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: University of Rochester; Trial completion date: Apr 2021 ➔ Apr 2022; Trial primary completion date: Apr 2021 ➔ Apr 2022

Trial completion date • Trial primary completion date • Muscular Dystrophy • IGF1

Adjuvant Growth Therapy in in Vitro Fertilization (clinicaltrials.gov) - P4; N=288; Active, not recruiting; Sponsor: OVO R & D; Trial completion date: Dec 2020 ➔ Sep 2021; Trial primary completion date: Dec 2020 ➔ Sep 2021

Trial completion date • Trial primary completion date • Gynecology • Infertility • Sexual Disorders

Monitoring Adherence Rate to Growth Hormone Therapy and Growth Outcomes in Taiwanese Children Using Easypod Connect: Observational Study. (PubMed, JMIR Pediatr Parent) - "With the easypod device, patients with inadequate adherence and poor response to treatment can be identified. Adherence to growth hormone therapy administered via easypod was generally high in the first year of treatment but the adherence gradually decreased over time. Overall, growth outcomes after 1 year indicated a positive growth response to growth hormone treatment. Future efforts should be focused on personalized management of adherence by using the easypod system."

Clinical • Journal • Observational data • Pediatrics

Impact of adherence on growth response during the first 2 years of growth hormone treatment. (PubMed, Endocrine) - "Adherence during the first 2 years of response was very high >90% and showed a negative association with age, pretreatment HV and treatment duration and a positive correlation with the level of parent education."

Journal

Adherence and long-term outcomes of therapy in paediatric patients in Greece using the easypod™ electromechanical device for growth hormone treatment: The phase IV multicentre easypod™ connect observational study (ECOS). (PubMed, Growth Horm IGF Res) - P=N/A | "rhGH replacement therapy using Saizen® with easypod™ led to full compliance to the treatment in a representative Greek population from ECOS, and provided additional insights on how the easypod™ device can assist physicians in monitoring adherence and help to optimise linear growth in paediatric patients with growth disorders."

Clinical • Journal • Observational data • P4 data • Endocrine Disorders • Genetic Disorders • Growth Hormone Deficiency • Pediatrics • Small for Gestational Age • Turners Syndrome

Designing a Personalized Digital Patient Support Program for Patients Treated With Growth Hormone: Key Design Considerations. (PubMed, J Med Internet Res) - "The patient support program that was designed is currently being piloted with patients to assess engagement with the program and determine its impact on patient outcomes. Results from the pilot will be used to further refine the program to ensure it meets user needs."

Clinical • Journal • Endocrine Disorders • Growth Hormone Deficiency

To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ (ECOS Taiwan, Indonesia, Singapore) (clinicaltrials.gov) - P=N/A; N=82; Completed; Sponsor: Merck KGaA, Darmstadt, Germany; N=35 ➔ 82

Clinical • Enrollment change • Endocrine Disorders • Pediatrics • IGF1

A pen device for injection of recombinant human growth hormone: a European usability engineering study. (PubMed, Expert Opin Drug Deliv) - "The pen device and associated materials benefited from Human Factors Engineering throughout the development process. These evaluations show that patients and HCPs could safely and effectively use the pen device, and the IFU and training were clear and effective."

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

Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Center for Human Reproduction

New P1/2 trial • Biosimilar • Growth Hormone • Oncology

Optimization of growth hormone dosing in children born small for gestational age: An open-label, randomized study of children during the fourth year of therapy (Horm Res Paediatr.) - P3, N=22; SGA OPTIMIS (NCT00249821); The 57μg/kg/day group continued with catch-up growth, had a significantly higher mean weight gain (p=0.015) & significantly higher insulin-like growth factor-I levels at 12 months (p=0.038); Five treatment-emergent adverse events were reported; none was serious or caused study withdrawal

P3 data • Growth Hormone

Comparative evaluation of short-term biomarker response to treatment for growth hormone deficiency in Chinese children with growth hormone deficiency born small for or appropriate for gestational age: A randomized phase IV open-label study (Ther Adv Endocrinol Metab) - P4, N=205; NCT01187550; MID: 23626901; "For children with GHD born SGA, IGF-I and IGFBP3 are short-term biomarkers of responsiveness to treatment with growth hormone, as for children with GHD born AGA."

P4 data • Growth Hormone

An open-label phase 4 study to explore immunogenicity of the liquid formulation of Saizen in subjects with growth hormone deficiency (GHD) of adult onset (clinicaltrials.gov) - P4, N=77; Sponsor: Merck KGaA; Not yet recruiting; New P4 trial.

New P4 trial • Growth Hormone