Trial reportHormone research in paediatrics2017
Pharmacokinetic and Pharmacodynamic Modeling of MOD-4023, a Long-Acting Human Growth Hormone, in Growth Hormone Deficiency Children.
Trial report in Hormone research in paediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Effect of Weekly Long-Acting Growth Hormone Replacement Therapy Compared to Daily Growth Hormone on Children With Short Stature: A Meta-Analysis.Frontiers in endocrinology · 2021Pooled it
- Efficacy and safety of long-acting growth hormone in children with short stature: a systematic review and meta-analysis.Endocrine · 2019Pooled it
- Efficacy and safety of once-weekly somatrogon following up to 4 years of treatment in Japanese children with growth hormone deficiency: results from an open-label extension of a phase 3 study.Endocrine journal · 2026Trial
- Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study.The Journal of clinical endocrinology and metabolism · 2022Trial
- Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study.Hormone research in paediatrics · 2022Trial
- Up to 5 years of weekly somatrogon in children with growth hormone deficiency: final data from the global phase 3 study.Journal of the Endocrine Society · 2026Article
- Extension of the Phase 3 Trial of Somatrogon in Children with Growth Hormone Deficiency: 3 Years of Safety and Efficacy.Hormone research in paediatrics · 2026Article
- Treatment with long-acting growth hormone: effectiveness and safety.Frontiers in endocrinology · 2026Review
- History and Current Status of Growth Hormone Treatment in Children.Paediatric drugs · 2025Article
- Long-Acting Growth Hormone for Pediatric Growth Hormone Deficiency.Journal of the Endocrine Society · 2025Review
- Article
- Somatrogon in pediatric growth hormone deficiency: a comprehensive review of clinical trials and real-world considerations.Annals of pediatric endocrinology & metabolism · 2025Article
- IGF-1 Assessment During Weekly Somatrogon Treatment in Pediatric Patients With GH Deficiency.Journal of the Endocrine Society · 2025Article
- Delphi-based Spanish consensus on the use of long-acting growth hormone in pediatric growth hormone deficiency: recommendations from the ConverGHe Working Group.Frontiers in endocrinology · 2025Article
- Current understanding and perspectives on growth and long-acting GH therapy in Japan.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2025Review
- Somatrogon: First Approval.Drugs · 2022Review
- Effect of Vitamin D Combined with Recombinant Human Growth Hormone in Children with Growth Hormone Deficiency.Disease markers · 2022Article
- Average IGF-1 Prediction for Once-Weekly Lonapegsomatropin in Children With Growth Hormone Deficiency.Journal of the Endocrine Society · 2022Article
- Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan.The Journal of clinical endocrinology and metabolism · 2021Article
- Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs.Frontiers in endocrinology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsMOD-4023 is a long-acting human growth hormone (hGH) in clinical trials for the treatment of growth hormone deficiency (GHD). A key goal is maintenance of serum concentrations of insulin-like growth factor (IGF) 1 within normal range throughout GH dosing. The study aimed to develop a pharmacokinetic model for MOD-4023 and a pharmacodynamic model for the effect of MOD-4023 on IGF-1 to allow estimation of peak and mean IGF-1 and to identify the optimal IGF-1 sampling day.
methodsMOD-4023 (0.25, 0.48, or 0.66 mg/kg) was administered weekly for 12 months to 41 GH-naive GHD children (age 3-11 years). The control group (n = 11, age 4-9 years) received daily recombinant human growth hormone (r-hGH; 34 µg/kg). Sparse samples (4/subject) were obtained to determine serum concentrations of MOD-4023 or r-hGH and IGF-1.
resultsA 2-compartment pharmacokinetic model with first-order absorption fit MOD-4023 data well; a 1-compartment model was appropriate for r-hGH. For both, weight-normalized systemic parameters were preferred over allometric scaling. For MOD-4023, an indirect model fit IGF-1 SDS data well; baseline IGF-1 increased over time. At steady state, samples obtained 4 days following dose administration predicted mean IGF-1 SDS during the dosing interval well.
conclusionThe IGF-1 profile is consistent with the weekly dosing interval. Sampling 4 days following dose administration allows estimation of mean IGF-1 SDS during the dosing interval in GHD patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.