drugset / Trial / NCT04615273

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

NCT04615273

Phase 3 Completed 264 enrolled Ascendis Pharma Endocrinology Division A/S
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Lonapegsomatropin Protein / enzyme biologic Subcutaneous
Comparator Somatropin Protein / enzyme biologic Subcutaneous

Indications