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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05171855




Registration number
NCT05171855
Ethics application status
Date submitted
24/09/2021
Date registered
29/12/2021
Date last updated
14/06/2024

Titles & IDs
Public title
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
Scientific title
A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
Secondary ID [1] 0 0
TCH-306EXT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Growth Hormone Deficiency 0 0
Endocrine System Diseases 0 0
Hormone Deficiency 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lonapegsomatropin

Experimental: Lonapegsomatropin - Lonapegsomatropin administered once-weekly by subcutaneous injection


Treatment: Drugs: Lonapegsomatropin
Study participants are individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events
Timepoint [1] 0 0
Throughout the 52 week treatment period
Secondary outcome [1] 0 0
Change from Baseline in Trunk Percent Fat
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Change from Baseline in Trunk Fat Mass
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Change from Baseline in Total Body Lean Mass
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Evaluate serum IGF-1 and IGF-1 SDS
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Evaluate serum hGH, lonapegsomatropin, and mPEG levels
Timepoint [5] 0 0
Week 52

Eligibility
Key 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 DXA scan
* Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above
Minimum age
23 Years
Maximum age
81 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diabetes mellitus if any of the following are met:

1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 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. Exceptions are:

1. Resection of in situ carcinoma of the cervix uteri
2. Complete eradication of squamous cell or basal cell carcinoma of the skin
* Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
* Female who is pregnant, plans to become pregnant, or is 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
Accrual to date
Final
233
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Ascendis Pharma Investigational Site - Saint Leonards
Recruitment hospital [2] 0 0
Ascendis Pharma Investigational Site - Sydney
Recruitment hospital [3] 0 0
Ascendis Pharma Investigational Site - Box Hill
Recruitment hospital [4] 0 0
Ascendis Pharma Investigational Site - Fitzroy
Recruitment hospital [5] 0 0
Ascendis Pharma Investigational Site - Parkville
Recruitment hospital [6] 0 0
Ascendis Pharma Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
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United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New York
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United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Armenia
State/province [14] 0 0
Yerevan
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
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Nantes
Country [19] 0 0
Georgia
State/province [19] 0 0
Tbilisi
Country [20] 0 0
Germany
State/province [20] 0 0
München
Country [21] 0 0
Greece
State/province [21] 0 0
Athens
Country [22] 0 0
Greece
State/province [22] 0 0
Thessaloníki
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Petah tikva
Country [25] 0 0
Israel
State/province [25] 0 0
Tel Aviv
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Italy
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Genova
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Italy
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Rome
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Japan
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Hyogo
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Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Chiba
Country [31] 0 0
Japan
State/province [31] 0 0
Fukuoka
Country [32] 0 0
Japan
State/province [32] 0 0
Ishikawa
Country [33] 0 0
Japan
State/province [33] 0 0
Kagoshima
Country [34] 0 0
Japan
State/province [34] 0 0
Kawasaki
Country [35] 0 0
Japan
State/province [35] 0 0
Kitakyushu
Country [36] 0 0
Japan
State/province [36] 0 0
Matsumoto
Country [37] 0 0
Japan
State/province [37] 0 0
Miyakojima
Country [38] 0 0
Japan
State/province [38] 0 0
Nagakute
Country [39] 0 0
Japan
State/province [39] 0 0
Nara
Country [40] 0 0
Japan
State/province [40] 0 0
Okayama
Country [41] 0 0
Japan
State/province [41] 0 0
Osaka
Country [42] 0 0
Japan
State/province [42] 0 0
Shizuoka
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Japan
State/province [43] 0 0
Suita
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Japan
State/province [44] 0 0
Yamagata
Country [45] 0 0
Japan
State/province [45] 0 0
Yokohama
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Soeul
Country [47] 0 0
Malaysia
State/province [47] 0 0
George Town
Country [48] 0 0
Malaysia
State/province [48] 0 0
Melaka
Country [49] 0 0
Malaysia
State/province [49] 0 0
Putrajaya
Country [50] 0 0
Poland
State/province [50] 0 0
Kraków
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Poland
State/province [52] 0 0
Wroclaw
Country [53] 0 0
Poland
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Lódz
Country [54] 0 0
Romania
State/province [54] 0 0
Bucharest
Country [55] 0 0
Romania
State/province [55] 0 0
Iasi
Country [56] 0 0
Serbia
State/province [56] 0 0
Belgrade
Country [57] 0 0
Slovakia
State/province [57] 0 0
Bratislava
Country [58] 0 0
Slovakia
State/province [58] 0 0
Lubochna
Country [59] 0 0
Spain
State/province [59] 0 0
Alicante
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
Sevilla
Country [62] 0 0
Turkey
State/province [62] 0 0
Ankara
Country [63] 0 0
Turkey
State/province [63] 0 0
Antalya
Country [64] 0 0
Turkey
State/province [64] 0 0
Aydin
Country [65] 0 0
Turkey
State/province [65] 0 0
Izmit
Country [66] 0 0
Turkey
State/province [66] 0 0
Kayseri
Country [67] 0 0
Ukraine
State/province [67] 0 0
Ivano-Frankivs'k
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kyiv
Country [69] 0 0
Ukraine
State/province [69] 0 0
Vinnytsia
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ascendis Pharma Endocrinology Division A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is 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 are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).
Trial website
https://clinicaltrials.gov/study/NCT05171855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries