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

Phase 3

Completed

• Conditions: Hormone Deficiency; Endocrine System Diseases; Growth Hormone Deficiency
• Interventions: Drug: Lonapegsomatropin; Other: Placebo; Drug: Somatropin

• Registration Number: NCT04615273
• Lead Sponsor: Ascendis Pharma Endocrinology Division A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Study Start: 2020-12-03
• Primary Completion: 2023-11-02
• Study Completion: 2023-12-01
• Status Verified: 2024-12
• Results First Submitted: 2024-12-20
• Results First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Results First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lonapegsomatropin	Lonapegsomatropin	Lonapegsomatropin administered once-weekly by subcutaneous injection.
Placebo	Placebo	Placebo for Lonapegsomatropin administered once-weekly by subcutaneous injection.
Somatropin	Somatropin	Somatropin administered once-daily by subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trunk Percent Fat at Week 38	Baseline, Week 38	Trunk percent fat was assessed by dual-energy X-ray absorptiometry.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Body Lean Mass at Week 38	Baseline, Week 38	Total body lean mass was assessed by dual-energy X-ray absorptiometry.
Change From Baseline in Trunk Fat Mass at Week 38	Baseline, Week 38	Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation	Up to 38 weeks	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does 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 is any untoward medical occurrence at any dose: resulted in death; was life threatening; required prolong inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect or was considered a significant medical event by the investigator.

Trial Locations

Locations (1)

Ascendis Pharma Investigational Site; 🇬🇧 Leeds, United Kingdom