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mgf growth factor other n=400 2023-02-03 ClinicalTrials

Long-Term Safety of Sogroya for Adult Growth Hormone Deficiency Under Investigation

A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

Background

Adult Growth Hormone Deficiency (AGHD) is a chronic condition requiring lifelong treatment, often with daily growth hormone injections. While Sogroya (somapacitan), a long-acting growth hormone, offers a convenient once-weekly dosing regimen, there's a critical need for extensive real-world data on its long-term safety and effectiveness in routine clinical practice. This multi-national observational study aims to address this gap by monitoring patients over an extended period.

Study Design

Population
Adults with Adult Growth Hormone Deficiency (AGHD), n=400, in a multi-national patient population.
Intervention
Sogroya (somapacitan), a once-weekly long-acting growth hormone, administered under routine clinical practice for nearly 10 years.
Outcome
The primary objective is to investigate the long-term safety profile of Sogroya, monitoring for adverse events and serious adverse events.

Results

As an ongoing, enrolling study, specific results regarding Sogroya's long-term safety and effectiveness are not yet available. However, the study is designed to gather comprehensive real-world data on the safety profile of Sogroya (somapacitan) in adults with AGHD. Researchers will meticulously monitor for adverse events, serious adverse events, and other safety outcomes over the nearly 10-year study period. The primary objective is to investigate the long-term safety of Sogroya in 400 participants under routine clinical practice, providing crucial real-world data on its tolerability. The study will also collect information on the effectiveness of Sogroya in managing AGHD symptoms and improving patient quality of life, as observed in a diverse, multi-national patient population, offering insights into its real-world utility.

Why It Matters

This study is crucial because it will provide much-needed long-term safety and effectiveness data for Sogroya (somapacitan) in a real-world setting, which is often different from controlled clinical trials. For patients with AGHD, who require lifelong treatment, understanding the sustained safety profile of a once-weekly option like Sogroya is paramount. The findings will be instrumental in informing clinical guidelines, enhancing physician confidence, and optimizing patient care decisions for this chronic condition. The completion of this nearly 10-year study will lead to a robust understanding of Sogroya's long-term impact.


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Source: clinicaltrials:NCT05718570 · Ingested 2026-05-01 · Digest: gemini-2.5-flash