Lonapegsomatropin for Growth Hormone Deficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the long-term safety and effectiveness of Lonapegsomatropin, a growth hormone therapy administered once a week to assist adults with growth hormone deficiency (GHD). The researchers aim to assess the treatment's efficacy over time and identify any side effects. Individuals who completed a previous study related to this treatment (TCH-306) and do not have certain eye problems or poorly controlled diabetes may qualify for this trial. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot use certain diabetes drugs other than metformin and DPP-4 inhibitors. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that Lonapegsomatropin is likely to be safe for humans?
Studies have shown that lonapegsomatropin is generally safe and well-tolerated. Earlier research found no new safety issues when used in children. Another study demonstrated its safety even with long-term use, with follow-up lasting up to six years, and no unexpected problems appeared over time.
It's important to note that people with certain conditions, such as an active tumor or a severe illness, should not use this medication. Overall, the safety data suggest that lonapegsomatropin is well-tolerated for its intended use.12345Why do researchers think this study treatment might be promising?
Lonapegsomatropin is unique because it offers a once-weekly subcutaneous injection for treating growth hormone deficiency, which can be more convenient compared to daily injections required by current treatments like somatropin. Researchers are excited about this treatment because it uses a prodrug formulation, meaning it releases the active hormone gradually, potentially improving adherence and outcomes. This innovative approach aims to simplify the treatment regimen, making life easier for patients and possibly enhancing their quality of life.
What evidence suggests that Lonapegsomatropin might be an effective treatment for growth hormone deficiency?
Research has shown that lonapegsomatropin effectively treats growth hormone deficiency. The foresiGHt trial found it to be a safe and reliable substitute for natural growth hormone. In studies with children, lonapegsomatropin consistently helped them grow taller over several years, effectively supporting growth in those lacking sufficient growth hormone. Participants in this trial will receive lonapegsomatropin as a once-weekly injection, providing a convenient way to manage the condition.678910
Who Is on the Research Team?
Claus Strange
Principal Investigator
Ascendis Pharma A/S
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
Trial Overview
The trial is testing Lonapegsomatropin's long-term effects when given once a week to adults with growth hormone deficiency. It's an open-label phase 3 study, meaning both researchers and participants know what treatment is being used.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascendis Pharma Endocrinology Division A/S
Lead Sponsor
Citations
12542 Results Of The Foresight Trial Support The Efficacy ...
ConclusionsThe results of the foresiGHt trial indicate that lonapegsomatropin is a safe, efficacious, and tolerable replacement for endogenous ...
Safety and Efficacy of Lonapegsomatropin in Children With ...
Overall, the mean (SD) duration of lonapegsomatropin treatment was 1.4 (0.4) years in enliGHten, with a maximum of 2.3 years. As specified by the parent trial ( ...
3.
karger.com
karger.com/hrp/article/doi/10.1159/000545064/923192/Children-with-Growth-Hormone-Deficiency-TreatedChildren with Growth Hormone Deficiency Treated ...
Children with growth hormone deficiency treated with Lonapegsomatropin demonstrated sustained height improvements for up to 6 years.
Study Details | NCT05171855 | A Trial to Investigate Long ...
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency · Study Overview · Contacts and Locations.
Children with Growth Hormone Deficiency Treated ...
Children with Growth Hormone Deficiency Treated with Lonapegsomatropin Demonstrated Sustained Height Improvements for up to 6 Years: enliGHten ...
Safety and Efficacy of Lonapegsomatropin in Children With ...
Children treated with once-weekly lonapegsomatropin showed continued improvement of height SDS through the second year of therapy without excess advancement of ...
Safety and Efficacy of Lonapegsomatropin in Children With ...
Conclusions: Treatment with lonapegsomatropin continued to be safe and well-tolerated, with no new safety signals identified. Children treated ...
NCT07221851 | Trial Investigating the Efficacy and Safety ...
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin ... Naïve to growth hormone and growth hormone promoting therapies.
Long-term Safety and Efficacy
Follow-up for up to 6 years demonstrated a safety profile consistent with prior observations (heiGHt and fliGHt), and no new signals.
Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Growth hormone medicines like Lonapegsomatropin Ascendis Pharma must not be used if the patient has an active tumour or an acute life-threatening illness. The ...
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