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A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature

NCT06382155 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).

Conditions

  • Idiopathic Short Stature

Interventions

DRUG

Vosoritide Injection

Experimental Drug Lyophilized powder for reconstitution

DRUG

Human Growth Hormone

Commercial product containing somatotropin

DRUG

Placebo

Lyophilized powder for reconstitution

Sponsors & Collaborators

Principal Investigators

  • Medical Director MD · BioMarin Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2026-06-30
Completion
2036-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382155 on ClinicalTrials.gov