Trial reportEuropean journal of endocrinology2017
MOD-4023, a long-acting carboxy-terminal peptide-modified human growth hormone: results of a Phase 2 study in growth hormone-deficient adults.
Trial report in European journal of endocrinology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis 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
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.
- 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 in adults with growth hormone deficiency: a randomized phase 3 study.Pituitary · 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
- Pharmacokinetic and Pharmacodynamic Modeling of MOD-4023, a Long-Acting Human Growth Hormone, in Growth Hormone Deficiency Children.Hormone research in paediatrics · 2017Trial
- Peptide and Protein Tags for the Half-Life Extension of Therapeutic Agents: A Review Article.The protein journal · 2026Review
- Treatment with long-acting growth hormone: effectiveness and safety.Frontiers in endocrinology · 2026Review
- Implementing a Bayesian approach using Stan with Torsten: Population pharmacokinetics analysis of somatrogon.CPT: pharmacometrics & systems pharmacology · 2025Article
- IGF-1 Assessment During Weekly Somatrogon Treatment in Pediatric Patients With GH Deficiency.Journal of the Endocrine Society · 2025Article
- Stable Production of a Recombinant Single-Chain Eel Follicle-Stimulating Hormone Analog in CHO DG44 Cells.International journal of molecular sciences · 2024Article
- Stable Production of a Tethered Recombinant Eel Luteinizing Hormone Analog with High Potency in CHO DG44 Cells.Current issues in molecular biology · 2024Article
- Novel therapies for growth disorders.European journal of pediatrics · 2024Review
- Actively separated microneedle patch for sustained-release of growth hormone to treat growth hormone deficiency.Acta pharmaceutica Sinica. B · 2023Article
- Spotlight on Lonapegsomatropin Once-Weekly Injection and Its Potential in the Treatment of Growth Hormone Deficiency in Pediatric Patients.Drug design, development and therapy · 2022Review
- PEGylated Recombinant Human Growth Hormone JintrolongFrontiers in endocrinology · 2022Article
- What do we do now that the long-acting growth hormone is here?Frontiers in endocrinology · 2022Review
- 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
- Evaluation of Nurses' and Patients' Overall Satisfaction with New and Previous Formulations of Octreotide Long-acting Release (Sandostatin LARAdvances in therapy · 2020Observational
- Long-Acting Growth Hormone Preparations - Current Status and Future Considerations.The Journal of clinical endocrinology and metabolism · 2020Review
- Association between Insulin-Like Growth Factor-1 and Relative Skeletal Maturation: A Retrospective Cohort Study of Short Children and Adolescents.BioMed research international · 2020Article
Corrections and comments
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Authors and funding
17 authors at 12 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveGrowth hormone (GH) replacement therapy currently requires daily injections, which may cause distress and low compliance. C-terminal peptide (CTP)-modified growth hormone (MOD-4023) is being developed as a once-weekly dosing regimen in patients with GH deficiency (GHD). This study's objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MOD-4023 administered once-weekly in GHD adults.
design54 adults with GHD currently treated with daily GH were normalized and randomized into 4 weekly dosing cohorts of MOD-4023 at 18.5%, 37%, 55.5% or 123.4% of individual cumulative weekly molar hGH dose. The study included 2 stages: Stage A assessed the effectiveness and PK/PD profiles of the 4 dosing regimens of MOD-4023. Stage B was an extension period of once-weekly MOD-4023 administration (61.7% molar hGH content) to collect further safety data and confirm the results from Stage A.
resultsDose-dependent response was observed for both PK and PD data of weekly MOD-4023 treatment. Insulin-like growth factor I (IGF-I) SDS levels were maintained within normal range. The 18.5% cohort was discontinued due to low efficacy. MOD-4023 was well tolerated and exhibited favorable safety profile in all dose cohorts. The reported adverse events were consistent with known GH-related side effects.
conclusionsOnce-weekly MOD-4023 administration in GHD adults was found to be clinically effective while maintaining a favorable safety profile and may obviate the need for daily injections. Weekly GH injections may improve compliance and overall outcome. The promising results achieved in this Phase 2 study led to a pivotal Phase 3 trial, which is currently ongoing.
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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.