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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lonapegsomatropin | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Somatropin | Protein / enzyme biologic | — | Subcutaneous |