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Lonapegsomatropin for Growth Hormone Deficiency
Study Summary
This trial is designed to evaluate the long-term safety and efficacy of a growth hormone deficiency treatment administered once-weekly. The study participants are adults (males and females) who have completed the treatment period in a previous study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My last eye exam showed no signs of high brain pressure or serious diabetes-related eye problems.I am taking diabetes medication that is not metformin or DPP-4 inhibitors.My diabetes is not well-controlled, with an HbA1C over 7.5%.You have had a bad reaction to the study drug somatropin or any of its ingredients in the past.I am not pregnant, planning to become pregnant, or breastfeeding.I am a woman able to have children and agree to use birth control during the trial.I am a male and willing to follow the contraceptive guidelines during the trial.I have cancer or a history of it, except for treated skin cancer or cervical carcinoma in situ.
- Group 1: Lonapegsomatropin
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the efficacy of Lonapegsomatropin in previous clinical trials?
"At this moment, there are 2 concurrent clinical trials testing Lonapegsomatropin. These studies have reached Phase 3 and are being conducted in 56 different locations."
Would this experiment be interested in participants who are over 30 years old?
"According to the inclusion criteria found on this clinical trial's website, 23 studies are for people under 18 years old and 28 are for patients 65 and older."
What is the FDA's assessment of Lonapegsomatropin?
"Given that this is a Phase 3 trial, our team has determined that the Lonapegsomatropin drug intervention is safe (scoring a 3 on our 1-3 scale). There is efficacy data as well as multiple rounds of safety data supporting this assumption."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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