drugset / Trial / NCT05690386
A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome
RandomizedParallel-groupOpen-labelTreatment
Summary
A 104 week dose finding open label trial followed by an optional 78 week open label extension of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus daily somatropin product in prepubertal individuals with Turner syndrome. Approximately 48 individuals (12 individuals per arm) will be randomized to receive one of three doses of lonapegsomatropin or a daily injection of somatropin. This is a trial that will be conducted in the United States.
Timeline
- Start
- 2023-02-15
- Primary completion
- 2024-10-18
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lonapegsomatropin | Protein / enzyme biologic | 0.24 mg/kg | Subcutaneous |
| Subject | Lonapegsomatropin | Protein / enzyme biologic | 0.3 mg/kg | Subcutaneous |
| Subject | Lonapegsomatropin | Protein / enzyme biologic | 0.36 mg/kg | Subcutaneous |
| Comparator | Somatropin | Protein / enzyme biologic | 0.05 mg/kg | Subcutaneous |