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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
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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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:
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I am taking diabetes medication that is not metformin or DPP-4 inhibitors.
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My diabetes is not well-controlled, with an HbA1C over 7.5%.
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I am not pregnant, planning to become pregnant, or breastfeeding.
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I am a woman able to have children and agree to use birth control during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Change from Baseline in Total Body Lean Mass
Change from Baseline in Trunk Fat Mass
Change from Baseline in Trunk Percent Fat
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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

Lonapegsomatropin (Growth Hormone Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05171855 — Phase 3
Growth Hormone Deficiency Research Study Groups: Lonapegsomatropin
Growth Hormone Deficiency Clinical Trial 2023: Lonapegsomatropin Highlights & Side Effects. Trial Name: NCT05171855 — Phase 3
Lonapegsomatropin (Growth Hormone Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05171855 — Phase 3
Growth Hormone Deficiency Patient Testimony for trial: Trial Name: NCT05171855 — Phase 3
~0 spots leftby Dec 2024
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