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Growth Hormone Product
Weekly Lonapegsomatropin for Growth Hormone Deficiency (foresiGHt Trial)
Phase 3
Waitlist Available
Research Sponsored by Ascendis Pharma Endocrinology Division A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 weeks
Awards & highlights
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.
Who is the study for?
Adults aged 23-80 with growth hormone deficiency can join this trial. They must not have had growth hormone therapy in the past year, be on a stable diet and exercise routine, and pass specific GH stimulation tests. People with certain genetic diseases, uncontrolled diabetes, recent cancers, or pituitary tumor growth are excluded.
What is being tested?
The trial is testing lonapegsomatropin (a long-acting growth hormone) given weekly against a placebo and daily somatropin injections for 38 weeks. Participants will be randomly assigned to one of these treatments in equal numbers across various global locations.
What are the potential side effects?
Potential side effects may include reactions at the injection site, headaches, joint pain, muscle pain, swelling due to fluid retention (edema), increased blood sugar levels and possible development of antibodies that might reduce the drug's effectiveness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 38 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Trunk Percent Fat
Secondary study objectives
Change from Baseline in Total Body Lean Mass
Change from Baseline in Trunk Fat Mass
Evaluate serum IGF-1 and IGFBP-3 and IGF-1 SDS and IGFBP-3 SDS
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LonapegsomatropinExperimental Treatment1 Intervention
Lonapegsomatropin administered once-weekly by subcutaneous injection
Group II: SomatropinActive Control1 Intervention
Somatropin administered once-daily by subcutaneous injection
Group III: PlaceboPlacebo Group1 Intervention
Placebo for Lonapegsomatropin administered once-weekly by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lonapegsomatropin
2020
Completed Phase 3
~270
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Who is running the clinical trial?
Ascendis Pharma Endocrinology Division A/SLead Sponsor
6 Previous Clinical Trials
1,989 Total Patients Enrolled
2 Trials studying Human Growth Hormone Deficiency
1,400 Patients Enrolled for Human Growth Hormone Deficiency
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Somatropin
- Group 3: Lonapegsomatropin
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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