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Growth Hormone Therapy

Navepegritide for Achondroplasia

Phase 2

Recruiting

Research Sponsored by Ascendis Pharma Growth Disorders A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

"This trial will test the safety and effectiveness of a new medication called Navepegritide in infants under 2 years old with a specific genetic condition. The medication will be given once a week

Who is the study for?

This trial is for infants under 2 years with achondroplasia, a form of dwarfism. Parents must consent and be able to give weekly shots at home. Babies up to 1 year old need daily Vitamin D; older ones with low levels must start supplements before joining.Check my eligibility

What is being tested?

The trial tests Navepegritide (TransCon CNP) against a placebo in babies with achondroplasia. It's given as a shot once a week for a year. The goal is to see if it's safe and works better than no treatment.See study design

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effect of Navepegritide on growth

To evaluate the safety and tolerability of Navepegritide

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NavepegritideExperimental Treatment1 Intervention

Once weekly double-blinded treatment with SC injection of 100 µg/kg of Navepegritide for 52 weeks

Group II: Placebo for NavepegritidePlacebo Group1 Intervention

Once weekly double-blinded treatment with SC injection of 100 µg/kg of Placebo for Navepegritide for 52 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ascendis Pharma Growth Disorders A/SLead Sponsor

2 Previous Clinical Trials

224 Total Patients Enrolled

2 Trials studying Achondroplasia

224 Patients Enrolled for Achondroplasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently being enrolled in this ongoing medical study?

"The current status on clinicaltrials.gov indicates that patient recruitment is ongoing for this study. The trial's initial posting was on January 23rd, 2024, with the most recent update made on March 20th, 2024."

Answered by AI

What are the potential risks associated with Navepegritide in individuals undergoing treatment?

"Based on our assessment at Power, the safety rating for Navepegritide is a 2. This determination stems from the trial being in Phase 2, where some data supports its safety profile but none yet support its efficacy."

Answered by AI

Who meets the eligibility criteria to participate in this research study?

"Individuals diagnosed with achondroplasia and aged between 0 to 2 years are eligible for participation in this research. Approximately 72 such candidates will be accepted into the trial."

Answered by AI

Is this trial available for individuals older than 25 years?

"Eligible candidates for this research study are limited to infants and toddlers aged between 0 and 2 years. Among the ongoing clinical trials, there are a total of 13 studies focused on individuals under 18 years old, while only three trials cater to participants above the age of 65."

Answered by AI

What is the total number of participants being recruited for this research endeavor?

"Affirmative. Information provided on clinicaltrials.gov confirms that this specific medical trial is actively pursuing eligible participants. The trial was originally posted on January 23, 2024, and its most recent update was made on March 20, 2024. A total of 72 patients are being sought across two designated sites for participation in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia

2024. "A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079398.

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