At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
Lonapegsomatropindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
In Brief
A Phase 3 clinical trial evaluating Lonapegsomatropin for Adult Growth Hormone Deficiency and 2 related conditions. Completed, enrolled 220 participants across 85 sites in 21 countries.
Detailed Summary
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants were adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt; NCT04615273).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArmenia, Australia, Canada, France, Georgia, Germany, Greece, Israel, Italy, Japan, Malaysia, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartDec 2021
First PostedDec 2021
Primary CompletionDec 2024
TodayJul 2026
First PostedDec 29, 2021
Enrollment StartDec 16, 2021
Primary CompletionDec 23, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.5 years ago
Interventions
Lonapegsomatropindrug
Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.