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Growth Hormone Receptor Agonist
Lonapegsomatropin for Growth Hormone Deficiency
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
Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above
Be older than 18 years old
Must not have
Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
Diabetes mellitus with poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 in trial TCH-306
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
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.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for growth hormone therapies include joint pain, swelling due to fluid retention, muscle pain, numbness or tingling skin sensations and increased cholesterol levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My last eye exam showed no signs of high brain pressure or serious diabetes-related eye problems.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking diabetes medication that is not metformin or DPP-4 inhibitors.
Select...
My diabetes is not well-controlled, with an HbA1C over 7.5%.
Select...
I am not pregnant, planning to become pregnant, or breastfeeding.
Select...
I am a woman able to have children and agree to use birth control during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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
Secondary outcome measures
Change from Baseline in Total Body Lean Mass
Change from Baseline in Trunk Fat Mass
Change from Baseline in Trunk Percent Fat
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LonapegsomatropinExperimental Treatment1 Intervention
Lonapegsomatropin administered once-weekly by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lonapegsomatropin
FDA approved
Find a Location
Who is running the clinical trial?
Ascendis Pharma Endocrinology Division A/SLead Sponsor
6 Previous Clinical Trials
2,020 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Lonapegsomatropin
Awards:
This trial has 3 awards, including:- 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.
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.
Growth Hormone Deficiency Patient Testimony for trial: Trial Name: NCT05171855 — Phase 3
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