Lonapegsomatropin for Growth Hormone Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This is 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 are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).
Are You a Good Fit for This Trial?
Adults with confirmed growth hormone deficiency who completed the TCH-306 study can join. They must have signed consent, finished previous trial treatments, and had certain medical checks without serious issues. People with uncontrolled diabetes, active cancer (with some exceptions), or unwillingness to use contraception cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lonapegsomatropin once-weekly by subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Long-term evaluation of safety and efficacy of Lonapegsomatropin
What Are the Treatments Tested in This Trial?
Interventions
- Lonapegsomatropin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascendis Pharma Endocrinology Division A/S
Lead Sponsor