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NCT05171855 · ClinicalTrials.gov registry record · Phase 3

A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

A Phase 3 study, sponsored by Ascendis Pharma Endocrinology Division A/S.

Completed
Registry status
Phase 3
Development phase
220
Enrollment target

NCT05171855: Completed Phase 3 study, sponsored by Ascendis Pharma Endocrinology Division A/S.

NCT05171855 is a Phase 3 study that has completed, run by Ascendis Pharma Endocrinology Division A/S. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05171855, a Phase 3 study, has completed, sponsored by Ascendis Pharma Endocrinology Division A/S.

COMPLETED
Registry status
Phase 3
Development phase
220 participants
Enrollment target

Study Summary

This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants were adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt; NCT04615273).

Primary Outcome

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE was any untoward medical occurrence at an

Interventions

  • DRUG Lonapegsomatropin

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2021-12-16
Est. Completion 2024-12-23
Phase Phase 3

What the finished NCT05171855 record still lists

NCT05171855 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 1 intervention - of which Lonapegsomatropin is the first listed.

NCT05171855 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05171855 about?

NCT05171855 is a clinical study titled "A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency". This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants were adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period ...

What is the current status of trial NCT05171855?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2021-12-16. Estimated completion is 2024-12-23.

What interventions are being tested in trial NCT05171855?

The interventions under investigation include: Lonapegsomatropin (DRUG).

Who is sponsoring clinical trial NCT05171855?

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

How this trial's enrollment target compares

Where NCT05171855's enrollment target sits among peer trials

220 1318th of 2000 higher than 672 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT05171855, the US trial registry maintained by the National Library of Medicine. NCT05171855 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.