Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06433557
PHASE2

A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia

Sponsor: Ascendis Pharma Growth Disorders A/S

View on ClinicalTrials.gov

Summary

This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.

Official title: A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia

Key Details

Gender

All

Age Range

2 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-07-26

Completion Date

2027-11

Last Updated

2026-02-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections

For navepegritide, a once weekly s.c. dose of 100 μg CNP/kg. For lonapegsomatropin, a once weekly s.c. dose of lonapegsomatropin 0.30 mg hGH/kg as starting dose. Treatment duration of up to 156 weeks.

Locations (3)

Ascendis Pharma Investigational Site

Copenhagen, Denmark

Ascendis Pharma Investigational Site

Dublin, Ireland

Ascendis Pharma Investigational Site

London, United Kingdom