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NCT06079398 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Achondroplasia, sponsored by Ascendis Pharma A/S.

Recruiting
Registry status
Phase 2
Development phase
72
Enrollment target
17
Study locations

NCT06079398 is a Phase 2 study of Achondroplasia that is actively recruiting participants, run by Ascendis Pharma A/S. The registered enrollment target is 72 participants, below the 143-participant average among 9 other Achondroplasia trials with a reported enrollment target (50% lower). The trial reports 17 study locations across 4 states.

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The verdict

NCT06079398, a Phase 2 study of Achondroplasia, is actively recruiting participants, sponsored by Ascendis Pharma A/S.

RECRUITING
Registry status
Phase 2
Development phase
72 participants
Enrollment target
17
Study locations

Study Summary

This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH, aged 0 to \< 2 years at the time of randomization.

Conditions Studied

Achondroplasia

Interventions

  • DRUG Navepegritide
  • DRUG Placebo for Navepegritide

Study Locations (17)

Other

  • Ascendis Investigational Site - Parkville
  • Ascendis Investigational Site - Linz
  • Ascendis Investigational Site - Copenhagen
  • Ascendis Investigational Site - Helsinki
  • Ascendis Investigational Site - Paris
  • Ascendis Investigational Site - Berlin
  • Ascendis Investigational Site - Cologne
  • Ascendis Investigational Site - Dublin
  • Ascendis Investigational Site - Milan
  • Ascendis Investigational Site - Auckland
  • Ascendis Investigational Site - Oslo
  • Ascendis Investigational Site - Coimbra
  • Ascendis Investigational Site - Stockholm
  • Ascendis Investigational Site - London

Minnesota

  • Ascendis Investigational Site - Saint Paul

Texas

  • Ascendis Investigational Site - Houston

Wisconsin

  • Ascendis Investigational Site - Madison

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2024-01-23
Est. Completion 2028-12
Phase Phase 2

Sponsor

Ascendis Pharma A/S

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06079398

The ClinicalTrials.gov registry entry for NCT06079398 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 9 other Achondroplasia trials with a reported enrollment target (50% lower). The listed sponsor is Ascendis Pharma A/S, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Achondroplasia appearing as the primary indexed condition, and to 2 interventions - of which Navepegritide is the first listed.

NCT06079398 reports 17 study locations spanning 4 distinct geographic areas - top geographies include Other, Minnesota, Texas.

Frequently Asked Questions

What is clinical trial NCT06079398 about?

NCT06079398 is a clinical study titled "A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia". This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetic...

What is the current status of trial NCT06079398?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2024-01-23. Estimated completion is 2028-12.

What conditions does trial NCT06079398 study?

This clinical trial studies the following conditions: Achondroplasia.

What interventions are being tested in trial NCT06079398?

The interventions under investigation include: Navepegritide (DRUG), Placebo for Navepegritide (DRUG).

Who is sponsoring clinical trial NCT06079398?

This trial is sponsored by Ascendis Pharma A/S, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06079398 being conducted?

This trial has 17 study locations across Minnesota, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.