Somapacitan Treatment in Children and Adolescents Born SGA: Two-Year Efficacy and Preference Over Daily GH

Clicks: 10
ID: 337764
2026
Free PDF
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This article has not been analysed, so there is no overall score — reader engagement is measured and shown alongside.
AI Quality Assessment
Not analyzed
Readership in this journal
Emerging

Ranked #436 of 449 articles by views in the journal of clinical endocrinology & metabolism

Most read Least read

Bar heights use a square-root scale. Only the 120 most-read articles are drawn; the journal has 449 in total.

Mint this article as an NFT
Not yet minted

Create a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.

5 SUSD one-off · no wallet required
Sign in to mint
Abstract
Abstract Context Children born small for gestational age (SGA) without spontaneous catch-up growth may require GH treatment; however, daily injections are burdensome. Somapacitan is a once-weekly long-acting GH. Objective To assess efficacy and safety of once-weekly somapacitan in children born SGA, including outcomes after switching from daily GH. Design REAL8 is a randomized, multinational, open-label, active-controlled phase 3 study with a 52-week main period and 104-week extension (NCT05330325). REAL9 (NCT05723835) is a multinational, open-label, uncontrolled phase 3 study. Setting Clinics across Europe, Asia, and the Americas. Participants REAL8 randomized 142 GH-treatment-naïve, prepubertal children born SGA; 141 received treatment and 139 completed 104 weeks. REAL9 enrolled 12 children/adolescents born SGA (GH-naïve or previously treated). Interventions In REAL8, participants were randomized (2:1:1) to somapacitan 0.24 mg/kg/week or daily GH (0.035 or 0.067 mg/kg/day) for 52 weeks; all received 0.24 mg/kg/week somapacitan in weeks 52–104. In REAL9, participants received 0.24 mg/kg/week somapacitan for 26 weeks. Main Outcome Measures Annualized height velocity (HV); secondary outcomes included height SD score (HSDS). Results In REAL8, mean HV during weeks 52–104 remained above baseline across groups (8.5–8.8 cm/year), including after switching from daily GH; HSDS increased through week 104, and IGF-I SDS were similar between groups. In REAL9, HV increased in GH-naïve participants and was maintained in previously treated participants. Somapacitan was well-tolerated; adverse events were mostly mild and injection-site reactions were infrequent. Most participants switching from daily GH preferred somapacitan. Conclusions In children born SGA, once-weekly somapacitan maintained efficacy through 2 years, with safety comparable to daily GH, and was preferred after switching.
Reference Key
openalex_W7224227770 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Aristides K Maniatis, Volker Böttcher, Michael Højby Rasmussen, Jan Frystyk, Xinran Cheng, Kenichi Kashimada, Anders Krogh Lemminger, Carlos Alberto Longui, Lawrence A. Silverman, Kamil Sołtysik, Agnès Linglart
Are you one of these authors? Claim your profile
Journal the journal of clinical endocrinology & metabolism
Year 2026
DOI
10.1210/clinem/dgag430
URL
https://doi.org/10.1210/clinem/dgag430
Keywords Keywords not found

Citations

No citations found. To add a citation, contact the admin at info@scimatic.org

Comments

No comments yet. Be the first to comment on this article.