NCT05171855

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Ascendis Pharma Endocrinology Division A/S · Industry
• Sex: All
• Age: 23 Years – 81 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Adult Growth Hormone Deficiency
• Endocrine System Diseases
• Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Lonapegsomatropin	Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

Timeline

• Start date: 2021-12-16
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2021-12-29
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

85 sites across 21 countries: United States, Armenia, Australia, Canada, France, Georgia, Germany, Greece, Israel, Italy, Japan, Malaysia, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study