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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lonapegsomatropin | Drug | Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Trunk Percent Fat at Week 52 | Trunk percent fat was assessed by dual-energy X-ray absorptiometry. | Baseline main trial to week 52 (extension period) |
| Change From Baseline in Trunk Fat Mass at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
Diabetes mellitus if any of the following were met:
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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| Name | Affiliation | Role |
|---|---|---|
| Study Director, MD | Ascendis Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascendis Pharma Investigational Site | Phoenix | Arizona | 85048 | United States | ||
| Ascendis Pharma Investigational Site |
The study TCH-306 EXT enrolled participants who had completed treatment in TCH-306 (NCT04615273) study. In Japan only, participants switched from commercially available somatropin therapy (results reported separately).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2023 | Dec 18, 2025 |
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Open label treatment with weekly Lonapegsomatropin
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|
Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
| Baseline main trial to week 52 (extension period) |
| Change From Baseline in Total Body Lean Mass at Week 52 | Total body lean mass was assessed by dual-energy X-ray absorptiometry. | Baseline main trial to week 52 (extension period) |
| Torrance |
| California |
| 90509 |
| United States |
| Ascendis Pharma Investigational Site | Chicago | Illinois | 60611 | United States |
| Ascendis Pharma Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Ascendis Pharma Investigational Site | Boston | Massachusetts | 02114 | United States |
| Ascendis Pharma Investigational Site | Dearborn | Michigan | 48126 | United States |
| Ascendis Pharma Investigational Site | Rochester | Minnesota | 55905 | United States |
| Ascendis Pharma Investigational Site | St Louis | Missouri | 63110 | United States |
| Ascendis Pharma Investigational Site | Las Vegas | Nevada | 89148 | United States |
| Ascendis Pharma Investigational Site | Reno | Nevada | 89511 | United States |
| Ascendis Pharma Investigational Site | New York | New York | 10017 | United States |
| Ascendis Pharma Investigational Site | Portland | Oregon | 97239 | United States |
| Ascendis Pharma Investigational Site | Dallas | Texas | 75390 | United States |
| Ascendis Pharma Investigational Site | San Antonio | Texas | 78232 | United States |
| Ascendis Pharma Investigational Site | Seattle | Washington | 98108 | United States |
| Ascendis Pharma Investigational Site | Yerevan | 0075 | Armenia |
| Ascendis Pharma Investigational Site | Saint Leonards | New South Wales | 2065 | Australia |
| Ascendis Pharma Investigational Site | Sydney | New South Wales | 2109 | Australia |
| Ascendis Pharma Investigational Site | Box Hill | Victoria | 3128 | Australia |
| Ascendis Pharma Investigational Site | Fitzroy | Victoria | 3065 | Australia |
| Ascendis Pharma Investigational Site | Parkville | Victoria | 3050 | Australia |
| Ascendis Pharma Investigational Site | Perth | Western Australia | 6009 | Australia |
| Ascendis Pharma Investigational Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Ascendis Pharma Investigational Site | Lyon | 69677 | France |
| Ascendis Pharma Investigational Site | Marseille | 13385 | France |
| Ascendis Pharma Investigational Site | Nantes | 44093 | France |
| Ascendis Pharma Investigational Site | Tbilisi | 0144 | Georgia |
| Ascendis Pharma Investigational Site | Tbilisi | 0159 | Georgia |
| Ascendis Pharma Investigational Site | München | 80336 | Germany |
| Ascendis Pharma Investigational Site | Athens | 11527 | Greece |
| Ascendis Pharma Investigational Site | Thessaloniki | 54636 | Greece |
| Ascendis Pharma Investigational Site | Haifa | 31048 | Israel |
| Ascendis Pharma Investigational Site | Petah Tikva | 4941480 | Israel |
| Ascendis Pharma Investigational Site | Tel Aviv | 6423906 | Israel |
| Ascendis Pharma Investigational Site | Genova | 16132 | Italy |
| Ascendis Pharma Investigational Site | Rome | 00161 | Italy |
| Ascendis Pharma Investigational Site | Rome | 00168 | Italy |
| Ascendis Pharma Investigational Site | Kobe | Hyōgo | 650-0047 | Japan |
| Ascendis Pharma Investigational Site | Kawasaki | Kanagawa | 216-8511 | Japan |
| Ascendis Pharma Investigational Site | Yokohama | Kanagawa | 222-0036 | Japan |
| Ascendis Pharma Investigational Site | Chiba | 260-8677 | Japan |
| Ascendis Pharma Investigational Site | Fukuoka | 812-8582 | Japan |
| Ascendis Pharma Investigational Site | Ishikawa | 920-0293 | Japan |
| Ascendis Pharma Investigational Site | Kagoshima | 890-8520 | Japan |
| Ascendis Pharma Investigational Site | Kawasaki | 210-0024 | Japan |
| Ascendis Pharma Investigational Site | Kawasaki | 211-8533 | Japan |
| Ascendis Pharma Investigational Site | Kitakyushu | 807-8555 | Japan |
| Ascendis Pharma Investigational Site | Matsumoto | 390-8510 | Japan |
| Ascendis Pharma Investigational Site | Miyakojima | 534-0021 | Japan |
| Ascendis Pharma Investigational Site | Nagakute | 480-1195 | Japan |
| Ascendis Pharma Investigational Site | Nara | 634-8522 | Japan |
| Ascendis Pharma Investigational Site | Okayama | 700-8558 | Japan |
| Ascendis Pharma Investigational Site | Osaka | 550-0006 | Japan |
| Ascendis Pharma Investigational Site | Shizuoka | 422-8527 | Japan |
| Ascendis Pharma Investigational Site | Suita | 565-0871 | Japan |
| Ascendis Pharma Investigational Site | Yamagata | 990-9585 | Japan |
| Ascendis Pharma Investigational Site | Yokohama | 236-0004 | Japan |
| Ascendis Pharma Investigational Site | George Town | 10450 | Malaysia |
| Ascendis Pharma Investigational Site | Malacca | 75400 | Malaysia |
| Ascendis Pharma Investigational Site | Putrajaya | 62250 | Malaysia |
| Ascendis Pharma Investigational Site | Krakow | 31-501 | Poland |
| Ascendis Pharma Investigational Site | Lodz | 93-338 | Poland |
| Ascendis Pharma Investigational Site | Warsaw | 03-242 | Poland |
| Ascendis Pharma Investigational Site | Wroclaw | 50-367 | Poland |
| Ascendis Pharma Investigational Site | Bucharest | 11868 | Romania |
| Ascendis Pharma Investigational Site | Iași | 700106 | Romania |
| Ascendis Pharma Investigational Site | Belgrade | 11000 | Serbia |
| Ascendis Pharma Investigational Site | Bratislava | 82606 | Slovakia |
| Ascendis Pharma Investigational Site | Ľubochňa | 3491 | Slovakia |
| Ascendis Pharma Investigational Site | Soeul | 06591 | South Korea |
| Ascendis Pharma Investigational Site | Alicante | 3010 | Spain |
| Ascendis Pharma Investigational Site | Barcelona | 8035 | Spain |
| Ascendis Pharma Investigational Site | Barcelona | 8041 | Spain |
| Ascendis Pharma Investigational Site | Seville | 41013 | Spain |
| Ascendis Pharma Investigational Site | Ankara | 06560 | Turkey (Türkiye) |
| Ascendis Pharma Investigational Site | Antalya | 07070 | Turkey (Türkiye) |
| Ascendis Pharma Investigational Site | Aydin | 09010 | Turkey (Türkiye) |
| Ascendis Pharma Investigational Site | İzmit | 41001 | Turkey (Türkiye) |
| Ascendis Pharma Investigational Site | Kayseri | 38039 | Turkey (Türkiye) |
| Ascendis Pharma Investigational Site | Ivano-Frankivsk | 76008 | Ukraine |
| Ascendis Pharma Investigational Site | Kyiv | 03115 | Ukraine |
| Ascendis Pharma Investigational Site | Kyiv | 04001 | Ukraine |
| Ascendis Pharma Investigational Site | Kyiv | 04114 | Ukraine |
| Ascendis Pharma Investigational Site | Vinnytsia | 21010 | Ukraine |
| Ascendis Pharma Investigational Site | Leeds | LS9 7TF | United Kingdom |
| 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. |
| FG002 | 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. |
| COMPLETED | Completed 52-Weeks Treatment in TCH-306 EXT |
|
| NOT COMPLETED |
|
|
Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT. | Posted | Count of Participants | Participants | Up to 52 Weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Trunk Percent Fat at Week 52 | Trunk percent fat was assessed by dual-energy X-ray absorptiometry. | Analysis was performed on safety analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent fat | Baseline main trial to week 52 (extension period) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Trunk Fat Mass at Week 52 | Trunk fat mass was assessed by dual-energy X-ray absorptiometry. | Analysis was performed on safety analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | kilograms | Baseline main trial to week 52 (extension period) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Body Lean Mass at Week 52 | Total body lean mass was assessed by dual-energy X-ray absorptiometry. | Analysis was performed on safety analysis set. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | kilograms | Baseline main trial to week 52 (extension period) |
|
From first dose of the study drug up to Week 52
Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 73 | 7 | 73 | 25 | 73 |
| EG001 | 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. | 0 | 73 | 4 | 73 | 29 | 73 |
| EG002 | 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. | 0 | 74 | 5 | 74 | 21 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Norovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebral cyst | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sarcoidosis of lymph node | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Ascendis Pharma | +45 61161658 | Asnd_registryinquiries@ascendispharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2024 | Dec 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723007 | lonapegsomatropin |
Not provided
Not provided
Not provided
| >= 30 to <= 60 years |
|
| > 60 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| TEAE Leading to Study Discontinuation |
|
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|
|
|