A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

NCT01909479 ↗

Phase 3 Terminated 202 enrolled OPKO Health, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

Timeline

Start: 2013-06
Primary completion: 2016-08
Completion: 2018-08

Outcome

Missed primary endpoint

Stopped: “Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated.”

paper change in trunk FM from baseline to Week 26 (-0.37 vs 0.03 kg; p=0.0821; primary endpoint) PMID 41879875 ↗

Publications

Fleseriu M, Biller BMK, Webb SM, Strasburger CJ, Georgescu CE, Bidlingmaier M, Wang C, Baciu I, Casanueva FF, Gilis-Januszewska A, Hart G, Manners A, Choe J, Bar-Ilan A, Carlsson M, Torre D, Taylor CT, Yuen KCJ. Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study. Pituitary. 2026 Mar 25;29(2):59. doi: 10.1007/s11102-026-01661-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatrogon	Protein / enzyme biologic	—	—