Work

Seven-year safety and efficacy of somapacitan in children with GH deficiency

Year: 2026

Type: article

Abstract: Background: Somapacitan is a once-weekly GH treatment that has shown efficacy and safety profiles equivalent to daily GH in children with GH deficiency (GHD). Objective: To investigate long-term safety, efficacy, and treatment burden associated with somapacitan after 7 years (364 weeks) of treatment. Methods: REAL 3 (NCT02616562) was a phase 2, randomized, open-label trial investigating the efficacy and safety of somapacitan vs daily GH in children with GHD. After 156 weeks, participants entered a 208-week safety extension. Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial

Source: DiRROS repository (University of Maribor)

Authors: Sävendahl, Lars, Battelino, Tadej, Højby Rasmussen, Michael, Leunbach, Tina, Saenger, Paul, Silverman, Lawrence, Horikawa, Reiko

Institutions: Karolinska University Hospital, Karolinska Institutet, University of Ljubljana, Ljubljana University Medical Centre, Novo Nordisk (Denmark), NYU Langone Health, Goryeb Children's Hospital, Atlantic Health System, National Center For Child Health and Development

Language: English

Topic: Growth Hormone and Insulin-like Growth Factors

Subfield: Endocrinology, Diabetes and Metabolism

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funder: Novo Nordisk

OpenAlex ID: W7139756185

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