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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-01-15

Study results available
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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

  • Growth Hormone Deficiency
  • Endocrine System Diseases
  • Hormone Deficiency

Interventions

DRUG

Lonapegsomatropin

Due to the different human growth hormone (hGH) dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.

OTHER

Placebo

The placebo for lonapegsomatropin drug product contained the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution was administered by subcutaneous (SC) injection via syringe and needle. Due to the different hGH dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo received the same dose volume as if they were randomized to once-weekly lonapegsomatropin.

DRUG

Somatropin

Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on participant's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.

Sponsors & Collaborators

  • Ascendis Pharma Endocrinology Division A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2023-11-02
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States
  • Armenia
  • Australia
  • Canada
  • Denmark
  • France
  • Georgia
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • New Zealand
  • 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 NCT04615273 on ClinicalTrials.gov