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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: Recruiting Phase 2 study of Achondroplasia, sponsored by Ascendis Pharma A/S.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of treatment emergent adverse events (TEAEs)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT06079398 shows while recruiting
NCT06079398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 143-participant average among 9 other Achondroplasia trials with a reported enrollment target (50% lower).
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 lists 17 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Achondroplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06079398's enrollment target sits among peer trials
72 9th of 9 higher than 1 of 9 other Achondroplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Achondroplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
RECRUITING · Phase 2
-
A Study of TYRA-300 in Children With Achondroplasia: BEACH301
RECRUITING · Phase 2
-
An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia
ACTIVE NOT RECRUITING · Phase 2
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A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH)
ACTIVE NOT RECRUITING · Phase 2
-
VIrtual STudy in Achondroplasia for the US (VISTA)
RECRUITING
-
Prospective Clinical Assessment Study in Children With Achondroplasia (ACH)
ACTIVE NOT RECRUITING
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