Somapacitan

Does Somapacitan work?

Yes, in large controlled trials; one covered 301 adults.

The adult approval rested on REAL 1, a randomized, double-blind, placebo-controlled and active-controlled trial of 301 adults with growth hormone deficiency, and the pediatric approvals on randomized trials against daily somatropin, the most recent being the REAL8 basket trial across three indications. The question these trials answer is whether weekly somapacitan matches daily growth hormone, and they show it does. ¹³

REAL 1 enrolled 301 adults with growth hormone deficiency who had not been treated before. Researchers randomized them to weekly somapacitan, daily somatropin, or weekly placebo for 34 weeks. The main measure was change in truncal fat percentage. It fell 1.06 percentage points with somapacitan and rose 0.47 points with placebo. That difference was significant. The change was similar to that with daily somatropin. Lean mass, visceral fat and IGF-1 moved in the expected directions. A 52-week extension brought total treatment to 86 weeks. The gains held on both somapacitan and daily growth hormone. ¹

In children, randomized trials against daily somatropin showed equivalent height velocity in growth hormone deficiency. REAL8 was a basket trial in prepubertal children who had not been treated before. They had idiopathic short stature, small-for-gestational-age short stature or Noonan syndrome. It met its main goal of non-inferior height velocity at 52 weeks in all three groups. Children and parents in these trials generally preferred the weekly schedule. ²³

Read the full Somapacitan page

Reference information only, not medical advice. Drawn from the Somapacitan article, fact-checked against the cited sources. No dosing anywhere on this site.