Trial reportClinical endocrinology2020
Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.
Trial report in Clinical endocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03075644 (A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan), which is not on this map. Cited by 19 papers, 3 of them syntheses 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 Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Once-weekly somapacitan vs. daily norditropin in GHD: a systematic review and meta-analysis of efficacy and safety in children and adults.Endocrine · 2026Pooled it
- Development of a Minimum Dataset for the Global Monitoring of the Safety and Efficacy of Growth Hormone Replacement in Adults With Growth Hormone Deficiency (AGHD).Clinical endocrinology · 2025Pooled it
- Pooled it
- 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
- Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.The Journal of clinical endocrinology and metabolism · 2022Trial
- Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency.European journal of endocrinology · 2022Trial
- Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.The Journal of clinical endocrinology and metabolism · 2022Trial
- Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.Clinical endocrinology · 2020Trial
- Influence of long-acting growth hormone analogs on other hypothalamic-pituitary axes: a real-world study.Journal of endocrinological investigation · 2026Article
- 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
- Distinct Glucose Profiles with Daily and Weekly Growth Hormone Therapy Revealed by Continuous Glucose Monitoring.Journal of the Endocrine Society · 2026Article
- Developments in the Management of Growth Hormone Deficiency: Clinical Utility of Somapacitan.Drug design, development and therapy · 2024Review
- Factors Related to Treatment Non-Adherence Among Caregivers of Pediatric and Adolescent Growth Hormone Deficiency Patients in Japan.Patient preference and adherence · 2024Article
- Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.Pituitary · 2023Article
- Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation.Frontiers in endocrinology · 2022Review
- Perception of Adherence to Daily Human Growth Hormone Treatments Among Pediatric and Adolescent Patients in Japan: A Cross-Sectional Survey of Physicians and Caregivers.Patient preference and adherence · 2022Article
- Changes, limitations, and prospects of adult height in GH treatment for Japanese GHD patients.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2022Review
- Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs.Frontiers in endocrinology · 2021Review
Corrections and comments
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Authors and funding
6 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSomapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once-weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD).
designPhase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644). PATIENTS: Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment. MEASUREMENTS: Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week 52 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT).
resultsMean (SD) prescribed doses after titration were 1.780 (1.058) mg/week for somapacitan and 0.197 (0.083) mg/day for daily GH. Rate of AEs per 100 patient-years was similar between arms (somapacitan, 312.7; daily GH, 309.8). Four AEs in the somapacitan arm were serious; none were considered treatment-related. Mean insulin-like growth factor-I standard deviation score (IGF-I SDS) was maintained from baseline in both arms. No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]: -1.74 [-18.13; 14.66], -11.53 [-35.54; 12.48] and - 12.85 [-47.31; 21.62] cm
conclusionsTreatment in both groups was well tolerated, with no unexpected safety findings. Impact on adipose tissue was similar to somapacitan and daily GH in patients with AGHD. A short visual summary of our work is available at https://bit.ly/3946YNF.
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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.