Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07221851 | Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders | PHASE3 | RECRUITING | 186 | — | — | Dec 12, 2025 | Mar 1, 2029 | May 29, 2026 | 15 | United States, France +3 |
| NCT05690386 | A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome | PHASE2 | ACTIVE NOT_RECRUITING | 48 | — | — | Feb 15, 2023 | Dec 1, 2027 | May 13, 2026 | 19 | United States |
To evaluate the efficacy of lonapegsomatropin as compared to somatropin in children and adolescents with TS, SHOX-D, SGA, or ISS
| Arm | Type | Description |
|---|---|---|
| Lonapegsomatropin, once daily | EXPERIMENTAL | Participants will receive Lonapegsomatropin by subcutaneous injection for 2 years (104 weeks) |
| somatropin, once daily | ACTIVE_COMPARATOR | Participants will receive somatropin by subcutaneous injection for 1 year (52 weeks) followed by lonapegsomatropin for 1 year (52 weeks) |
| Lonapegsomatropin at 0.24 mg hGH/kg/week | EXPERIMENTAL | Lonapegsomatropin at 0.24 mg hGH/kg/week administered once-weekly by subcutaneous injection |
| Lonapegsomatropin at 0.30 mg hGH/kg/week | EXPERIMENTAL | Lonapegsomatropin at 0.30 mg hGH/kg/week administered once-weekly by subcutaneous injection |
| Lonapegsomatropin at 0.36 mg hGH/kg/week | EXPERIMENTAL | Lonapegsomatropin at 0.36 mg hGH/kg/week administered once-weekly by subcutaneous injection |
| Somatropin at 0.05 mg/kg/day | ACTIVE_COMPARATOR | Somatropin at 0.05 mg/kg/day administered once-daily by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Lonapegsomatropin [SKYTROFA®] | COMBINATION_PRODUCT | Subcutaneous injection once weekly |
| Somatropin Pen Injector | COMBINATION_PRODUCT | Subcutaneous injection once daily |
| Lonapegsomatropin | BIOLOGICAL | Once-weekly subcutaneous injection of Lonapegsomatropin |
| Somatropin | DRUG | Once-daily subcutaneous injection of Somatropin |
Inclusion Criteria: 1. Chronological age between ≥2 and \<18 years, at start of screening. 2. Naïve to growth hormone and growth hormone promoting therapies. 3. Prepubertal. 4. Able to stand without assistance. 5. Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according...