A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

Summary

A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.

Timeline

Start

2020-12-03

Primary completion

2023-11-02

Completion

2023-12-01

Outcome

Met primary endpoint

registry analysis (superiority test); Lonapegsomatropin vs Placebo; p <.0001; Estimate of Difference -2.04 (95% CI -2.94 to -1.14); ANCOVA NCT04615273 ↗

Drugs

Indications