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

NCT05171855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-01-09

Study results available
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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).

Conditions

  • Hormone Deficiency
  • Adult Growth Hormone Deficiency
  • Endocrine System Diseases

Interventions

DRUG

Lonapegsomatropin

Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

Sponsors & Collaborators

  • Ascendis Pharma Endocrinology Division A/S

    lead INDUSTRY

Principal Investigators

  • Claus Strange · Ascendis Pharma A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2024-12-23
Completion
2024-12-23
FDA Drug
Yes

Countries

  • United States
  • Armenia
  • Australia
  • Canada
  • France
  • Georgia
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171855 on ClinicalTrials.gov