A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
- Conditions
- Endocrine System DiseasesHormone DeficiencyAdult Growth Hormone Deficiency
- Interventions
- Registration Number
- NCT05171855
- Lead Sponsor
- Ascendis Pharma Endocrinology Division A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
- 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
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Diabetes mellitus if any of the following are met:
- Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 in trial TCH-306
- Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
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Active malignant disease or history of malignancy. Exceptions are:
- Resection of in situ carcinoma of the cervix uteri
- Complete eradication of squamous cell or basal cell carcinoma of the skin
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Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
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Female who is pregnant, plans to become pregnant, or is breastfeeding
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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
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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
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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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lonapegsomatropin Lonapegsomatropin Lonapegsomatropin administered once-weekly by subcutaneous injection
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events Throughout the 52 week treatment period To evaluate the safety and tolerability of once-weekly lonapegsomatropin in adults with growth hormone deficiency
- Secondary Outcome Measures
Name Time Method Change from Baseline in Total Body Lean Mass Week 52 Change from baseline in total body lean mass (as assessed by dual-energy x ray absorptiometry \[DXA\]) at Week 52
Change from Baseline in Trunk Fat Mass Week 52 Change from baseline in trunk fat mass (as assessed by dual-energy x ray absorptiometry \[DXA\]) at Week 52
Evaluate serum IGF-1 and IGF-1 SDS Week 52 To evaluate the pharmacodynamics (PD) of once-weekly lonapegsomatropin in adults with growth hormone deficiency
Change from Baseline in Trunk Percent Fat Week 52 Change from baseline in trunk percent fat (as assessed by dual-energy x ray absorptiometry \[DXA\]) at Week 52
Evaluate serum hGH, lonapegsomatropin, and mPEG levels Week 52 To evaluate the pharmacokinetics (PK) of once-weekly lonapegsomatropin in adults with growth hormone deficiency
Trial Locations
- Locations (1)
Ascendis Pharma Investigational Site
🇬🇧Leeds, United Kingdom