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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: Completed Phase 3 study of Growth Hormone Deficiency and Endocrine System Diseases, sponsored by Ascendis Pharma Endocrinology Division A/S.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Trunk percent fat was assessed by dual-energy X-ray absorptiometry.

Conditions Studied

Growth Hormone Deficiency Endocrine System Diseases Hormone Deficiency

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
Ascendis Pharma Endocrinology Division A/S

7 total trials

What the finished NCT04615273 record still lists

NCT04615273 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 371-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (29% lower).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Growth Hormone Deficiency

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04615273's enrollment target sits among peer trials

264 4th of 16 higher than 13 of 16 other Growth Hormone Deficiency trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Growth Hormone Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04615273, the US trial registry maintained by the National Library of Medicine. NCT04615273 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.