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NCT05690386 · ClinicalTrials.gov registry record · Phase 2

A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome

A Phase 2 study of Turner Syndrome, sponsored by Ascendis Pharma Endocrinology Division A/S.

Active
Registry status
Phase 2
Development phase
48
Enrollment target
19
Study locations

NCT05690386 is a Phase 2 study of Turner Syndrome that is active but no longer recruiting, run by Ascendis Pharma Endocrinology Division A/S. The registered enrollment target is 48 participants, below the 516-participant average among 14 other Turner Syndrome trials with a reported enrollment target (91% lower). The trial reports 19 study locations across 16 states.

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The verdict

NCT05690386, a Phase 2 study of Turner Syndrome, is active but no longer recruiting, sponsored by Ascendis Pharma Endocrinology Division A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
48 participants
Enrollment target
19
Study locations

Study Summary

A 104 week dose finding open label trial followed by an optional 78 week open label extension of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus daily somatropin product in prepubertal individuals with Turner syndrome. Approximately 48 individuals (12 individuals per arm) will be randomized to receive one of three doses of lonapegsomatropin or a daily injection of somatropin. This is a trial that will be conducted in the United States.

Conditions Studied

Turner Syndrome

Interventions

  • DRUG Somatropin
  • BIOLOGICAL Lonapegsomatropin

Study Locations (19)

California

  • Ascendis Pharma Investigational Site - Palo Alto
  • Ascendis Pharma Investigational Site - San Diego

Florida

  • Ascendis Pharma Investigational Site - Orlando
  • Ascendis Pharma Investigational Site - St. Petersburg

Texas

  • Ascendis Pharma Investigational Site - El Paso
  • Ascendis Pharma Investigational Site - Fort Worth

Colorado

  • Ascendis Pharma Investigational Site - Aurora

Georgia

  • Ascendis Pharma Investigational Site - Atlanta

Idaho

  • Ascendis Pharma Investigational Site - Idaho Falls

Illinois

  • Ascendis Pharma Investigational Site - Chicago

Massachusetts

  • Ascendis Pharma Investigational Site - Boston

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2023-02-15
Est. Completion 2027-12
Phase Phase 2

Sponsor

Ascendis Pharma Endocrinology Division A/S

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05690386

The ClinicalTrials.gov registry entry for NCT05690386 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 516-participant average among 14 other Turner Syndrome trials with a reported enrollment target (91% lower). The listed sponsor is Ascendis Pharma Endocrinology Division A/S, which has 7 total studies on file at ClinicalTrials.gov.

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

NCT05690386 reports 19 study locations spanning 16 distinct geographic areas - top geographies include California, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT05690386 about?

NCT05690386 is a clinical study titled "A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome". A 104 week dose finding open label trial followed by an optional 78 week open label extension of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus daily somatropin product in prepubertal individuals with Turner syndrome. Approximately 48 individuals (12 individ...

What is the current status of trial NCT05690386?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2023-02-15. Estimated completion is 2027-12.

What conditions does trial NCT05690386 study?

This clinical trial studies the following conditions: Turner Syndrome.

What interventions are being tested in trial NCT05690386?

The interventions under investigation include: Somatropin (DRUG), Lonapegsomatropin (BIOLOGICAL).

Who is sponsoring clinical trial NCT05690386?

This trial is sponsored by Ascendis Pharma Endocrinology Division A/S, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05690386 being conducted?

This trial has 19 study locations across California, Colorado, Florida, Georgia, Idaho. 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.