NCT05171855|CompletedPhase 3ResultsFDA Drug

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

A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

Ascendis Pharma Endocrinology Division A/S ClinicalTrials.gov

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1 other identifier

TCH-306EXT

Study Type

interventional

Target

220

Locations

21 countries

Sites

Timeline

RegisteredDec 2021

StartedDec 2021

CompletionDec 2024

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

220

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Dec 2021

Typical duration for phase_3

Geographic Reach

21 countries

85 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

September 24, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

December 16, 2021

Completed

13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

January 9, 2026

Completed

Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

September 24, 2021

Results QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

Adult Growth Hormone Deficiency Endocrine System Diseases Hormone Deficiency

Keywords

Human Growth HormonehGHrhGHGHDAdult Growth Hormone DeficiencyLong Acting Growth HormoneLonapegsomatropinProdrugGrowth Hormone Replacement TherapySustained Release Growth HormoneGrowth Hormone DeficiencyTransCon hGHSkytrofa

Outcome Measures

Primary Outcomes (1)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
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 any dose that met any of the following criteria: resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the trial drug or was considered a significant medical event by the investigator.
Up to 52 Weeks

Secondary Outcomes (3)

Change From Baseline in Trunk Percent Fat at Week 52
Baseline main trial to week 52 (extension period)
Change From Baseline in Trunk Fat Mass at Week 52
Baseline main trial to week 52 (extension period)
Change From Baseline in Total Body Lean Mass at Week 52
Baseline main trial to week 52 (extension period)

Study Arms (3)

Lonapegsomatropin/Lonapegsomatropin

EXPERIMENTAL

Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

Drug: Lonapegsomatropin

Placebo/Lonapegsomatropin

EXPERIMENTAL

Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

Drug: Lonapegsomatropin

Somatropin/Lonapegsomatropin

EXPERIMENTAL

Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.

Drug: Lonapegsomatropin

Interventions

LonapegsomatropinDRUG

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

Also known as: ACP-011

Lonapegsomatropin/LonapegsomatropinPlacebo/LonapegsomatropinSomatropin/Lonapegsomatropin

Eligibility Criteria

Age23 Years - 81 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signing of the trial specific informed consent
Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 dual-X-ray-absorptiometry (DXA) scan
Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above

You may not qualify if:

Diabetes mellitus if any of the following were met:
Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
Active malignant disease or history of malignancy.
Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
Female who was pregnant, plans to become pregnant, or was breastfeeding
Female participant of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/section 10.4 of the protocol
Male participant not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/ section 10.4 of the protocol
Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures

Contact the study team to confirm eligibility.