Once-weekly human GH increases total body lean mass for adults with GH deficiency
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Key takeaways:
- In a phase 3 trial, lonapegsomatropin was associated with more fat loss in the trunk than placebo.
- Body composition changes with lonapegsomatropin were similar to those observed with somatropin.
A once-weekly human growth hormone therapy conferred a greater reduction in trunk fat mass and a greater increase in total body lean mass than placebo, according to topline results from a phase 3 trial.
Lonapegsomatropin (TransCon hGH, Ascendis Pharma), a once-weekly human GH, was deemed superior to placebo in the foresiGHt trial, a phase 3 randomized, parallel arm, placebo-controlled and active-controlled trial. In the trial, 259 adults aged 23 to 80 years with GH deficiency were randomly assigned, 1:1:1, to receive either lonapegsomatropin once-weekly, somatropin once-daily or placebo for 38 weeks. A target dose was determined based on age and oral estrogen intake.
At 38 weeks, the lonapegsomatropin group had a reduction in trunk percent fat of –1.67% compared with a 0.37% increase with placebo (P < .0001). Those receiving lonapegsomatropin had a greater increase in total body lean mass (mean difference, 1.7 kg; P < .0001) and a greater reduction in trunk fat mass (mean difference, –0.7 kg; P = .0053) than placebo.
In an exploratory post-hoc analysis, researchers compared lonapegsomatropin with once-daily somatropin among adults with an IGF-1 standard deviation score of 1.75 or less at 38 weeks. In this group, lonapegsomatropin was associated with a similar decrease in trunk fat mass and a similar increase in total body lean mass as somatropin.
Lonapegsomatropin had similar safety and tolerability to somatropin. No discontinuations related to the study drug were reported.
“TransCon hGH, our once-weekly GH, is designed to deliver unmodified somatropin, thereby preserving the same overall endocrine benefits inherent in endogenous and daily human GH,” Jan Mikkelsen, president and CEO of Ascendis Pharma, said in a press release. “Next year, we plan to submit a supplemental Biologics License Application to the U.S. FDA for the adult GH deficiency indication and look forward to reporting data from our phase 2 program in Turner syndrome.”
In addition to the topline results on lonapegsomatropin, Ascendis Pharma also announced that an investigational agent was associated with health and quality of life improvements for children with achondroplasia. In an open-label extension of a phase 2 trial, children aged 2 to 10 years with achondroplasia receiving 100 ug/kg per week of navepegritide (TransCon CNP, Ascendis Pharma) had improvements in growth, health-related quality of life and disease impacts. Ascendis Pharma said further details on the results will be released early in 2024.
Reference:
Significant health and quality of life improvements achieved in children with achondroplasia treated for one year with TransCon CNP (Navepegritide) at 100 µg/kg/week. Available at: https://investors.ascendispharma.com/news-releases/news-release-details/significant-health-and-quality-life-improvements-achieved. Published Dec. 20, 2023. Accessed Dec. 27, 2023.
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