somatropin / Generic mfg. - LARVOL DELTA

Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Baylor College of Medicine | Trial completion date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: May 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult)

Efficacy of alternative Somatropine-rhGH treatment for the management of SHOX-related short stature (ESPE 2024) - "In our experience, the switch from Humatrope® to the alternative rhGH somatropine resulted in a similar response to treatment regarding both height velocity growth and height growth. This may provide evidence for an alternative rhGH brand to use in patients affected by SHOX-related short stature. Further analysis on safety and compliance aspects related to the alternative rhGH treatment will be evaluated."

Clinical

Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Baylor College of Medicine | Not yet recruiting ➔ Recruiting | N=36 ➔ 20

Enrollment change • Enrollment open • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult)

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

Cost Offset and Budget Impact of Skytrofa for the Treatment of Pediatric Growth Hormone Deficiency: A US Payer’s Perspective (ISPOR-EU 2023) - " This BIA compares two hypothetical scenarios: (1) only current daily GHs available (Norditropin®, Genotropin®, and Humatrope®) and (2) Skytrofa, a once-weekly alternative, is introduced to the market. Adding Skytrofa to the formulary for the treatment of pGHD has a minimal budget impact from US payers’ perspective while maintaining or improving growth outcomes."

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

Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS) (clinicaltrials.gov) - P4 | N=5 | Terminated | Sponsor: University of Nebraska | N=30 ➔ 5

Enrollment change • Gastrointestinal Disorder • Short Bowel Syndrome

Pancreatic Clamp in NAFLD (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Columbia University

New P1 trial • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Obesity • APOB

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

[VIRTUAL] The efficacy and safety of recombinant biosimilar growth hormone treatment in children with GHD and SGA: a Czech retrospective national longitudinal study (ESPE 2021) - "The aim of our study is to assess height gain and safety of therapy with biosimilar rhGH (Omnitrope®, Sandoz) in Czech children with GHD and SGA over the first three years of treatment and to compare our data with longitudinal international study GeNeSIS Italian Cohort (Humatrope®, Eli Lilly). Our data confirm significant improvement of growth parameters and safety of therapy with biosimilar rhGH Omnitrope® in Czech children with GHD and SGA which is consistent with results from international database GeNeSIS study."

Observational data • Retrospective data • Endocrine Disorders • Growth Hormone Deficiency • Infectious Disease • Nephrology • Respiratory Diseases • Small for Gestational Age

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

Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis (clinicaltrials.gov) - P3; N=21; Completed; Sponsor: The Hospital for Sick Children; Recruiting ➔ Completed

Clinical • Trial completion • Osteoporosis • Pediatrics • Rheumatology

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

"@LillyPad Humatrope Injection Shortage in Pakistan ?" (@KashirKhan_)

Growth Hormone and GnRH Agonist in Adolescents With Acquired Hypothyroidism (clinicaltrials.gov) - P4; N=16; Terminated; Sponsor: Baylor College of Medicine; Completed ➔ Terminated

Clinical • Trial termination • Endocrine Disorders

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

A prospective observational study of effect of somatropin on growth hormone deficient adults (HypoCCS) (clinicaltrials.gov) - P=Obs, N=8,000; Sponsor: Eli Lilly and Company; Enrolling by invitation -> Completed.

Trial completion • Growth Hormone

Final height and safety outcomes in GH-treated children with short stature homeobox-containing gene (SHOX) deficiency: Experience from a large, multinational, and prospective observational study (ESPE 2014) - Abstract #P-D-1-3-160; P=Obs, N=444; GeNeSIS (NCT01088412); Sponsor: Eli Lilly and Company; "Initial GH dose was 0.30±0.10 mg/kg per week, increasing at FH by <10%. FH at age of 15.5±1.5 years and after 4.2±2.3 years of GH treatment was −1.6±1.1 SDS; height gain from baseline was 0.9±1.0 SDS. Of 434 patients with SHOX-D and ≥1 follow-up visit (2.9±1.8 years follow-up), ≥1 adverse event was reported for 89 (21%) compared with 5214/18 929 (28%) for GeNeSIS overall and 710/1663 (43%) for TS."

Observational data • Growth Hormone

Drug approval reports (FDA) - Labeling Revision for Humatrope on 07/30/2014.

FDA event • Growth Hormone

Somatropin + leuprorelin vs somatropin alone in pubertal children with idiopathic short stature (Phoenix) (clinicaltrials.gov) - P3, N=88; Active, not recruiting; Completion date: Mar 2015 -> Jun 2015

Trial completion date • Growth Hormone

STARFISH: Study of Testosterone and rHGH in FSHD (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: University of Rochester; Trial completion date: Jul 2020 ➔ Apr 2021; Trial primary completion date: Jul 2020 ➔ Apr 2021

Trial completion date • Trial primary completion date • Genetic Disorders • Muscular Dystrophy • Oncology • Solid Tumor • IGF1

Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF (clinicaltrials.gov) - P1/2; N=30; Enrolling by invitation; Sponsor: Center for Human Reproduction; Trial completion date: Jun 2019 ➔ Jun 2022; Trial primary completion date: Jun 2018 ➔ Jun 2021

Trial completion date • Trial primary completion date

Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation (clinicaltrials.gov) - P2/3; N=1126; Terminated; Sponsor: The University of Texas Medical Branch, Galveston; Trial completion date: Sep 2018 ➔ Jul 2019; Recruiting ➔ Terminated; At the request of the study site, this study has been closed and access to study-related data is unavailable. We are unable to submit the results-data.

Trial completion date • Trial termination