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Growth Hormone Analog

TransCon hGH for Growth Hormone Deficiency (enliGHten Trial)

Phase 3
Waitlist Available
Research Sponsored by Ascendis Pharma A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

enliGHten Trial Summary

This trial is testing a long-term extension of a growth hormone given once a week to children with growth hormone deficiency. Approximately 300 children will be included from various countries, and all will receive the hormone.

Eligible Conditions
  • Childhood-onset Growth Hormone Deficiency
  • Pituitary Disease
  • Endocrine Disorders
  • Hormone Deficiency

enliGHten Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]
Secondary outcome measures
Annualized height velocity (HV) with long-term dosing of weekly TransCon hGH treatment
Change in height standard deviation scores with long-term dosing of weekly TransCon hGH treatment
Incidence of antibodies against TransCon hGH with long-term dosing of weekly TransCon hGH treatment
+1 more

Side effects data

From 2019 Phase 3 trial • 146 Patients • NCT03305016
12%
Pyrexia
10%
Nasopharyngitis
10%
Upper respiratory tract infection
8%
Headache
5%
Oropharyngeal pain
1%
Atrioventricular block
1%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lonapegsomatropin

enliGHten Trial Design

1Treatment groups
Experimental Treatment
Group I: TransCon hGHExperimental Treatment1 Intervention
Once weekly subcutaneous injection of TransCon hGH
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved

Find a Location

Who is running the clinical trial?

Ascendis Pharma A/SLead Sponsor
11 Previous Clinical Trials
1,259 Total Patients Enrolled
Michael Beckert, MDStudy DirectorAscendis Pharma A/S
7 Previous Clinical Trials
441 Total Patients Enrolled
Aimee D Shu, MDStudy DirectorAscendis Pharma, Inc.
3 Previous Clinical Trials
390 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for this clinical trial?

"According to the latest information available on clinicaltrials.gov, this particular study is not recruiting patients at this time. The trial was first posted on December 19th, 2017 and was last updated on October 13th, 2021. Although this particular trial has finished enrolling candidates, there are 108 other trials that are still looking for test subjects."

Answered by AI

How many research participants are being asked to join this clinical trial?

"This study is no longer recruiting patients. The clinical trial was originally posted on December 19th, 2017 and was last updated on October 13th, 2021. However, there are currently 73 trials searching for patients with pituitary diseases and 35 studies for TransCon hGH that are actively looking for participants."

Answered by AI

Does the FDA have any reservations about TransCon hGH?

"TransCon hGH is estimated to be a safe medication, as it has received a score of 3. This is due to the fact that this drug is currently in Phase 3 trials, meaning that there is some efficacy data as well as multiple rounds of safety data supporting its use."

Answered by AI

Have similar clinical trials been conducted in the past?

"TransCon hGH has had 35 active trials over the course of 15 years, with the first one being conducted in 2005. So far, these trials have taken place across 170 cities and 45 countries. The initial trial, which was sponsored by BioPartners GmbH, completed Phase 3 drug approval after enrolling 144 patients. In total, 209 clinical trials have been done involving Transcon hGH."

Answered by AI

How many research facilities are coordinating this experiment?

"There are 21 sites currently active for this study, with locations including Charlottesville, New york and Tacoma. If you choose to participate in this trial, please select the site closest to your residence to minimize travel inconvenience."

Answered by AI

For what sorts of medical conditions is TransCon hGH generally prescribed?

"TransCon hGH is not just for general surgery patients. It can also help people who are dealing with short stature, open epiphyses, and antiretroviral therapy."

Answered by AI

What are the most similar medical trials to TransCon hGH?

"The first clinical trials studying TransCon hGH took place in 2005 at the Children's Hospital of Philadelphia. As of now, 209 have completed the study. There are 35 active trials being conducted with a large number taking place in Charlottesville, Virginia."

Answered by AI

Does this experimental treatment include elderly participants?

"Among the 154 total trials, this study is for children aged 1 year to 18 years old."

Answered by AI

To whom does this research opportunity extend?

"Researchers are looking for 300 individuals that have a pituitary gland disease and fall in the 1-18 year old age range. The key requirements for participants are as follows: Children who have not taken a permanent break from the study drug in the last trial."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Ascendis Pharma Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
~41 spots leftby Apr 2025