Trial reportThe Journal of clinical endocrinology and metabolism2023
Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.
Trial report in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02616562 (A Randomised, Multinational, Active-controlled,), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomised, Multinational, Active-controlled, (Open-labelled), Dose Finding, (Double-blinded), Parallel Group Trial Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- Pooled it
- Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.Hormone research in paediatrics · 2026Trial
- Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.The Journal of clinical endocrinology and metabolism · 2025Trial
- Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial.Frontiers in endocrinology · 2025Trial
- Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH.The Journal of clinical endocrinology and metabolism · 2023Trial
- Growth Hormone Therapy in Children Born Small for Gestational Age with Persistent Short Stature: Lessons Learned from Real-World International Databases and Directions for Future Research.Hormone research in paediatrics · 2026Review
- Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data.Hormone research in paediatrics · 2026Article
- Adherence to daily growth hormone therapy in Japan: real-world data from the Melon Nikki™ app and device.Journal of the Endocrine Society · 2026Article
- Can long-acting growth hormone improve adherence in pediatric growth hormone deficiency?Endocrine · 2026Review
- Optimization of dosing regimens for the long-acting growth hormone pegpesen: A population PK/PD modeling approach.Journal of endocrinological investigation · 2026Article
- Seven-year Safety and Efficacy of Somapacitan in Children With GH Deficiency: Final Results From REAL 3.Journal of the Endocrine Society · 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 hormones: innovations in treatment and guidance on patient selection in pediatric growth hormone deficiency.Annals of pediatric endocrinology & metabolism · 2025Article
- Long-Acting Growth Hormone Therapy in Pediatric Growth Hormone Deficiency: A Consensus Statement.The Journal of clinical endocrinology and metabolism · 2025Article
- Growth Response to Weekly Somapacitan Therapy in Children With GH Deficiency Is Related to GH Thresholds in GH Stimulation Testing.Journal of the Endocrine Society · 2025Article
- Safety and efficacy of weekly somapacitan for growth hormone deficiency in children: A 72-week observational study.Saudi medical journal · 2025Observational
- Severe Lipoatrophy in a Growth Hormone Deficient Toddler Girl Treated with a Non-Pegylated Long-Acting Growth Hormone.Children (Basel, Switzerland) · 2025Article
- New directions in growth hormone treatment in children.Pediatric endocrinology, diabetes, and metabolism · 2025Review
- Usability and Preference Evaluation of the Somapacitan Pen-Injector and Lonapegsomatropin Autoinjector: Results of a US-Based Simulated-Use Study with Adolescent Patients and Caregivers.Patient preference and adherence · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextGrowth hormone deficiency (GHD) in children is currently treated with daily injections of GH, which can be burdensome for patients and their parents/guardians. Somapacitan is a GH derivative in development for once-weekly treatment of GHD.
objectiveThis work aimed to assess the efficacy and safety of somapacitan, and associated disease/treatment burden, after 4 years of treatment and 1 year after switching to somapacitan from daily GH.
methodsThis long-term safety extension of a multicenter, controlled phase 2 trial (NCT02616562) took place at 29 sites in 11 countries. Patients were prepubertal, GH-naive children with GHD. Fifty patients completed 4 years of treatment. Patients in the pooled group received somapacitan (0.04, 0.08, 0.16 mg/kg/week) for 1 year, followed by the highest dose (0.16 mg/kg/week) for 3 years. Patients in the switched group received daily GH 0.034 mg/kg/day for 3 years, then somapacitan 0.16 mg/kg/week for 1 year. Main outcome measures were height velocity (HV), change from baseline in HV SD score (SDS), change from baseline in height SDS, disease burden, and treatment burden for patients and parents/guardians.
resultsChanges from baseline in HV and HV SDS were similar and as expected in both groups. Observer-reported outcomes showed that patients and parents/guardians seem to have experienced a reduced treatment burden when switching from daily GH to somapacitan. Most parents/guardians (81.8%) strongly/very strongly preferred somapacitan over daily GH.
conclusionsSomapacitan showed similar efficacy and safety in patients who continued somapacitan treatment and those who switched from daily GH to somapacitan. Once-weekly injections may lead to a reduced treatment burden relative to once-daily injections. A plain-language summary of this work is available.
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What OpenQuestion holds
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.