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ACTIVE NOT RECRUITING Phase 2

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

NCT05690386 · View on ClinicalTrials.gov ↗

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

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascendis Pharma Endocrinology Division A/S, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05690386 reports 19 study locations spanning 16 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05690386?

The interventions under investigation include: Somatropin (DRUG), Lonapegsomatropin (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05690386?

This trial is sponsored by Ascendis Pharma Endocrinology Division A/S, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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