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COMPLETED Phase 3

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

NCT04615273 · View on ClinicalTrials.gov ↗

Study Summary

A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.

Interventions

  • OTHER Placebo
  • DRUG Somatropin
  • DRUG Lonapegsomatropin

Study Locations (20)

California

  • Ascendis Pharma Investigational Site — Fresno
  • Ascendis Pharma Investigational Site — Los Angeles
  • Ascendis Pharma Investigational Site — Los Angeles
  • Ascendis Pharma Investigational Site — Palo Alto
  • Ascendis Pharma Investigational Site — Torrance

Nevada

  • Ascendis Pharma Investigational Site — Las Vegas
  • Ascendis Pharma Investigational Site — Reno

New York

  • Ascendis Pharma Investigational Site — New York
  • Ascendis Pharma Investigational Site — New York

Alabama

  • Ascendis Pharma Investigational Site — Birmingham

Arizona

  • Ascendis Pharma Investigational Site — Phoenix

Illinois

  • Ascendis Pharma Investigational Site — Chicago

Indiana

  • Ascendis Pharma Investigational Site — Indianapolis

Massachusetts

  • Ascendis Pharma Investigational Site — Boston

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2020-12-03
Est. Completion 2023-12-01
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04615273

The ClinicalTrials.gov registry entry for NCT04615273 describes a study currently listed as completed. It is categorized as Phase 3, 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 264 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 3 conditions, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT04615273 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Nevada, New York. 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 NCT04615273 about?

NCT04615273 is a clinical study titled "A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency". A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficie...

What is the current status of trial NCT04615273?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2020-12-03. Estimated completion is 2023-12-01.

What conditions does trial NCT04615273 study?

This clinical trial studies the following conditions: Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04615273?

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

Who is sponsoring clinical trial NCT04615273?

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 NCT04615273 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Illinois, Indiana. 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