Trial reportPituitary2026
Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study.
Trial report in Pituitary, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01909479 (A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product (MOD-4023) In Adult Subjects With Growth Hormone Deficiency
Who cites it
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study assessed the efficacy and safety of once-weekly somatrogon, a long-acting growth hormone, in adults with growth hormone deficiency (aGHD).
methodsA 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.
resultsOf 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.
conclusionSomatrogon significantly improved several body composition parameters and was well tolerated overall in adults with GHD. CLINICALTRIALS.GOV: NCT01909479; registration date: 25/07/2013
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