Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT05171855Other idTCH-306EXT

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 220 participants (actual)
Sponsor: Ascendis Pharma Endocrinology Division A/S · Industry
Design: Not randomized · Open label (no masking)
Countries: 21 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
Start: 16 Dec 2021
Primary completion: 23 Dec 2024
Completion: 23 Dec 2024
First posted: 29 Dec 2021
Last update posted: 7 Jul 2026
Conditions: Adult Growth Hormone Deficiency · Endocrine System Diseases · Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022202320242025

Ph 3
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
NCT05171855
16 Dec 2021 to 23 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

LonapegsomatropinDrug

Arms3

Experimental
Lonapegsomatropin/Lonapegsomatropin
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.
Experimental
Placebo/Lonapegsomatropin
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.
Experimental
Somatropin/Lonapegsomatropin
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
Time frame · Up to 52 Weeks
Registry description
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.

Secondary outcomes(3)

Change From Baseline in Trunk Percent Fat at Week 52
Time frame · Baseline main trial to week 52 (extension period)
Registry description
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Change From Baseline in Trunk Fat Mass at Week 52
Time frame · Baseline main trial to week 52 (extension period)
Registry description
Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
Change From Baseline in Total Body Lean Mass at Week 52
Time frame · Baseline main trial to week 52 (extension period)
Registry description
Total body lean mass was assessed by dual-energy X-ray absorptiometry.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Up to 52 Weeks

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation

Group	Value (Participants)
Lonapegsomatropin/Lonapegsomatropin	48
Placebo/Lonapegsomatropin	52
Somatropin/Lonapegsomatropin	45

Secondary and other outcome results(3)

Secondary outcomeLeast squares mean· Baseline main trial to week 52 (extension period)

Change From Baseline in Trunk Percent Fat at Week 52

Group	Value (percent fat)
Lonapegsomatropin/Lonapegsomatropin	-1.21
Placebo/Lonapegsomatropin	-1.60
Somatropin/Lonapegsomatropin	-1.11

Secondary outcomeLeast squares mean· Baseline main trial to week 52 (extension period)

Change From Baseline in Trunk Fat Mass at Week 52

Group	Value (kilograms)
Lonapegsomatropin/Lonapegsomatropin	0.15
Placebo/Lonapegsomatropin	-0.16
Somatropin/Lonapegsomatropin	-0.00

Secondary outcomeLeast squares mean· Baseline main trial to week 52 (extension period)

Change From Baseline in Total Body Lean Mass at Week 52

Group	Value (kilograms)
Lonapegsomatropin/Lonapegsomatropin	2.26
Placebo/Lonapegsomatropin	1.97
Somatropin/Lonapegsomatropin	2.07

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lonapegsomatropin/LonapegsomatropinParticipants 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.	1 / 73	7 / 73	25 / 73
Placebo/LonapegsomatropinParticipants 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.	0 / 73	4 / 73	29 / 73
Somatropin/LonapegsomatropinParticipants 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.	0 / 74	5 / 74	21 / 74

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 23 Years up to 81 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * Diabetes mellitus if any of the following were met: 1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306 2. 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

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