What question did this study set out to answer?

To evaluate the efficacy and safety of somatrogon in adults with growth hormone deficiency.

March 27, 2026Open Access

Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study

Key Points

To evaluate the efficacy and safety of somatrogon in adults with growth hormone deficiency.
Conducted a 26-week double-blind, placebo-controlled trial.
Participants were randomized 2:1 to receive either somatrogon or placebo.
Included assessments of trunk fat mass, lean body mass, and adverse events.
Followed by a 26-week open-label extension and multi-year continuation.
Somatrogon did not significantly change trunk fat mass compared to placebo.
There were significant improvements in lean body mass and trunk fat mass as a percentage of total fat mass.
Most adverse events were mild to moderate and similarly occurred in both treatment groups.

Abstract

This study assessed the efficacy and safety of once-weekly somatrogon, a long-acting growth hormone, in adults with growth hormone deficiency (aGHD). A phase 3 randomized, double-blind, placebo-controlled study consisted of a 26-week double-blind period (Period 1), a 26-week open-label extension (OLE; Period 2), and a multi-year OLE (Period 3). Patients were randomized 2:1 to somatrogon or placebo in Period 1, with dosing adjusted for gender, age, and estrogen therapy. All patients received somatrogon in Periods 2 and 3. Primary endpoint was change in trunk fat mass (FM; baseline-Week 26). Secondary endpoints included changes in total FM, lean body mass (LBM), percentage change in trunk FM, and trunk FM. Changes in percent trunk FM relative to total trunk mass (FM + LBM), trunk LBM, and appendicular skeletal muscle mass were also evaluated in a post-hoc supplemental analysis. Safety assessments included adverse events (AEs) and laboratory evaluations. Of 389 patients screened, 202 were randomized, and 198 received treatment (somatrogon:133; placebo:65). Mean IGF-I SDS normalized following somatrogon initiation. There was no significant difference between somatrogon and placebo in change in trunk FM from baseline to Week 26 (-0.37 vs 0.03 kg; p=0.0821; primary endpoint) or in total FM. However, somatrogon significantly improved LBM, trunk FM as a percentage of total FM and the three supplemental endpoints. AE incidence was similar between groups, with most being mild to moderate in severity. Somatrogon significantly improved several body composition parameters and was well tolerated overall in adults with GHD. NCT01909479; registration date: 25/07/2013

AIに質問

Bookmark

View Full Paper