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Once-weekly somapacitan is effective and well tolerated in adults with GH deficiency: A randomized phase 3 trial

Journal of Clinical Endocrinology & Metabolism Mar 20, 2020

Johannsson G, Gordon MB, Rasmussen MH, et al. - Researchers conducted this randomized phase 3 trial to test the safety and effectiveness of somapacitan, a once-weekly reversible albumin-binding growth hormone (GH) derivative, vs placebo in adult growth hormone deficiency (AGHD). Of the 457 individuals initially screened, 301 were randomized to receive once-weekly somapacitan (n = 121), once-weekly placebo (n = 61), or daily GH (n = 119). Participants in the study were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period). Patients continued treatment with somapacitan or daily GH during the 52-week extension period. Somapacitan administered once weekly in AGHD patients showed superiority over placebo, and the overall therapeutic effects and safety of somapacitan were up to 86 weeks of treatment in line with known effects and safety of GH replacement. Somapacitan in AGHD may provide an effective alternative to daily GH.

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