Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study.
Anders JuulPhilippe BackeljauwMichael HøjbyMasanobu KawaiRasmus Juul KildemoesAgnès LinglartNehama Zuckerman-LevinReiko HorikawaPublished in: European journal of endocrinology (2023)
Based on the totality of data on improvements in height-based parameters combined with exposure-response analyses, somapacitan 0.24 mg/kg/week appears most efficacious, providing similar efficacy, safety, and tolerability as daily GH 0.067 mg/kg/day in short children born SGA after 26 weeks of treatment.
Keyphrases
- gestational age
- open label
- birth weight
- preterm birth
- young adults
- clinical trial
- phase ii
- phase iii
- placebo controlled
- body mass index
- phase ii study
- study protocol
- electronic health record
- randomized controlled trial
- double blind
- low birth weight
- squamous cell carcinoma
- machine learning
- big data
- deep learning
- data analysis
- weight gain
- replacement therapy