Recruiting

teACHNavepegritide for Growth in Adolescents with Achondroplasia

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What is being tested

Navepegritide

+ Placebo for navepegritide

Drug
Who is being recruted

Achondroplasia+5

+ Bone Diseases

+ Bone Diseases, Developmental

From 12 to 17 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorAscendis Pharma A/S
Study ContactAscendis Registry Inquiries
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 10, 2024

Actual date on which the first participant was enrolled.

This study aims to assess how effective and safe the medication navepegritide is for teenagers aged 12 to 18 who have achondroplasia, a condition that affects bone growth and can lead to shorter stature. The trial focuses on whether a weekly injection of navepegritide can improve the growth rate in these adolescents over a year-long period. The participants' annual growth rate is closely monitored to understand if the treatment offers significant benefits over a placebo, which is an inactive substance that looks like the drug but has no effect. Participants in the study receive either the navepegritide injection or a placebo once a week for 52 weeks. The primary measurement of the trial's success is the Annualized Growth Velocity, which is how much the participants grow in height over the year. By comparing the growth rates of those receiving the medication against those taking the placebo, researchers aim to determine the effectiveness of navepegritide in promoting growth. The study also carefully monitors any side effects to ensure the treatment is safe for adolescents with achondroplasia.

Official TitleA Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of Navepegritide Administered Once Weekly for 52 Weeks in Adolescents (12-18 Years of Age) With Achondroplasia.
NCT06732895
Principal SponsorAscendis Pharma A/S
Study ContactAscendis Registry Inquiries
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AchondroplasiaBone DiseasesBone Diseases, DevelopmentalDwarfismMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOsteochondrodysplasiasGenetic Diseases, Inborn

Criteria

5 inclusion criteria required to participate
Written, signed informed consent and/or assent of the participant, participant parent(s) or legal guardian(s) of the participant, and as required by the institutional review board/human research ethics committee/independent ethics committee (IRB/HREC/IEC). For participants who are below the age of consent, a written assent will be obtained in accordance with applicable requirements as required by IRB/HREC/IEC. Upon reaching the legal age of consent, depending on applicable requirements, these participants will be asked to give their own written consent.
Male or female, between 12 (inclusive) and 18 years of age at the time of randomization
Clinical diagnosis of ACH with documented genetic confirmation available. Documentation of historic test results are acceptable for proof of diagnosis.
Parent(s)/legal guardian(s) willing and able to administer weekly SC injections of IMP and to follow the protocol.
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19 exclusion criteria prevent from participating
Known history of any bone-related surgery affecting growth potential of long bones, such as: * Orthopedic reconstructive surgery for bone lengthening (e.g., procedures for leg bowing such as 8-plate are not exclusionary). * Ventriculoperitoneal (VP) shunt and laminectomy with full recovery are allowed with minimum of 6 months of bone healing. * Bone fracture within 6 months prior to screening (within 2 months for fracture of digits and buckle fractures).
Participation (signed informed consent) in any interventional clinical trial within 3 months prior to Screening unless no doses of IMP was given.
Decreased growth velocity (AGV less than 1.5 cm/year based on measurement over a period of at least 6 months) or radiological evidence of growth plate closure.
Known or suspected hypersensitivity to the IMP or related products (trehalose, tris\[hydroxymethyl\]aminomethane, succinate, and mPEG).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Ascendis Investigational Site

Montreal, CanadaOpen Ascendis Investigational Site in Google Maps
Recruiting

Ascendis Investigational Site

Copenhagen, Denmark
Recruiting

Ascendis Investigational Site

Paris, France
Recruiting

Ascendis Investigational Site

Dublin, Ireland
Recruiting
5 Study Centers