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Weekly Lonapegsomatropin for Growth Hormone Deficiency (foresiGHt Trial)
foresiGHt Trial Summary
This trial is testing a new, long-acting growth hormone product given once a week, versus a placebo control and daily somatropin product, in adults with growth hormone deficiency.
foresiGHt Trial Timeline
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.foresiGHt Trial Design
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- You have a current or past history of cancer, with some exceptions.You have had a pituitary adenoma or other non-cancerous brain tumor that has grown in the last 12 months before screening.You have acromegaly or Cushing's disease that has not improved within a certain period of time.You have Prader-Willi Syndrome or other genetic diseases that could affect the study's goals.You have been diagnosed with diabetes and it is not well controlled, or it was diagnosed less than 26 weeks ago, or you recently changed your diabetes treatment, or you have certain serious diabetes-related problems.You had a stroke within the past 5 years before the screening.You have taken anabolic steroids or certain types of corticosteroids in the past 90 days.You have a history of drug or alcohol abuse, or you have had an eating disorder.You have tested positive for HIV, hepatitis B, or hepatitis C.You must be between 23 and 80 years old to participate.You have not received growth hormone treatment or medications that stimulate growth hormone production for at least 12 months before screening.Your growth hormone level after a macimorelin test is less than or equal to 2.8 ng/mL.You have been very sick or had serious complications within the last six months.You have severe heart failure.Your heart takes too long to recharge between beats, as shown on a heart test.Your high blood pressure is not well controlled.You have a history of certain brain diseases, surgeries, or injuries that affect your hormone levels.You have a history of certain brain diseases or injuries that can cause growth hormone deficiency in adults.You need to pass specific tests related to growth hormone if you are in Japan.You have a history of antibodies that can stop the human growth hormone from working.Your kidney function, measured by eGFR, is less than 60 mL/min/1.73m2.You have had radiation treatment to your head or surgery on your pituitary gland or hypothalamus within a certain time period.Your liver enzymes (AST or ALT) are more than three times the normal limit.You have had a bad reaction to the test drug somatropin or any of its ingredients before.You cannot get a DXA scan or the results of your DXA scan are unclear.You need to have low levels of growth hormone as evidenced by specific medical tests.Your thyroid hormone levels are normal when tested at the central laboratory.Your growth hormone level does not peak above 5 ng/mL during an insulin tolerance test.You will undergo a glucagon stimulation test based on your body mass index (BMI).You are between 23 and 80 years old.Criterion: Criteria used to diagnose adult growth hormone deficiency (AGHD).
- Group 1: Placebo
- Group 2: Somatropin
- Group 3: Lonapegsomatropin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 medical conditions does Lonapegsomatropin typically help to improve?
"Lonapegsomatropin can be used to effectively treat general surgery, short stature, and open epiphyses."
Can elders participate in this research project?
"This particular study requires that participants are within the ages of 23-80, however, there are other clinical trials for those outside of this age range. For example, 46 studies exist for people under 18 and 39 for seniors over the age of 65."
What are the preliminary findings of other research groups using Lonapegsomatropin?
"Out of the 36 ongoing studies on Lonapegsomatropin, 15 are in their third phase. This medication is being trialed extensively in Philadelphia, Pennsylvania but there are a total of 647 locations running these clinical trials."
Are patients being enrolled in this trial at the current time?
"That is correct, the online information does show that the trial is currently ongoing. The clinical trial was first posted on December 3rd 2020 and was edited most recently on April 12th 2022. They are searching for a total of 240 participants from 19 different sites."
Are there long-term health concerns with taking Lonapegsomatropin?
"There is some evidence to suggest that Lonapegsomatropin is effective and safe, as this medication has reached Phase 3 in clinical trials."
If I take part in this trial, what are the benefits for me?
"This prospective study is investigating the effect of a new medication on endocrine system diseases. Those between 23 and 80 years old may be eligible to participate, with around 240 people needed for the trial."
Do we have precedent for this kind of medical research?
"Lonapegsomatropin has a long research history dating back to 2005 when the first trial, sponsored by BioPartners GmbH, was conducted. This initial study only involved 144 individuals. However, after this Phase 3 drug approval, Lonapegsomatropin's clinical trials expanded rapidly. As of now, there are 36 live trials in 170 different cities and across 45 countries worldwide."
Are there other research centers participating in this clinical trial within the state?
"Enrollment for this trial is currently open at 19 locations, which are situated in cities such as Reno, Phoenix and Boston. If you are considering participating in this study, it would be convenient to choose a location near you to limit travel time and costs."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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