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NCT04615273 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Growth Hormone Deficiency and Endocrine System Diseases, sponsored by Ascendis Pharma Endocrinology Division A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
- 20
- Study locations
NCT04615273 is a Phase 3 study of Growth Hormone Deficiency and Endocrine System Diseases that has completed, run by Ascendis Pharma Endocrinology Division A/S. The registered enrollment target is 264 participants, below the 371-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT04615273, a Phase 3 study of Growth Hormone Deficiency and Endocrine System Diseases, has completed, sponsored by Ascendis Pharma Endocrinology Division A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| 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, categorized as Phase 3. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 371-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (29% 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 3 conditions, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04615273 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Nevada, New York.
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.
What interventions are being tested in trial NCT04615273?
The interventions under investigation include: Placebo (OTHER), Somatropin (DRUG), Lonapegsomatropin (DRUG).
Who is sponsoring clinical trial NCT04615273?
This trial is sponsored by Ascendis Pharma Endocrinology Division A/S, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
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