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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05171855
Recruitment Status : Recruiting
First Posted : December 29, 2021
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Ascendis Pharma A/S ( 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).

Condition or disease Intervention/treatment Phase
Adult Growth Hormone Deficiency Endocrine System Diseases Hormone Deficiency Drug: Lonapegsomatropin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label treatment with weekly Lonapegsomatropin
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
Actual Study Start Date : December 16, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025


Arm Intervention/treatment
Experimental: Lonapegsomatropin
Lonapegsomatropin administered once-weekly by subcutaneous injection
Drug: Lonapegsomatropin
Study participants are individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks
Other Name: ACP-011




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 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 :
  1. Change from Baseline in Trunk Percent Fat [ Time Frame: Week 52 ]
    Change from baseline in trunk percent fat (as assessed by dual-energy x ray absorptiometry [DXA]) at Week 52

  2. Change from Baseline in Trunk Fat Mass [ Time Frame: Week 52 ]
    Change from baseline in trunk fat mass (as assessed by dual-energy x ray absorptiometry [DXA]) at Week 52

  3. Change from Baseline in Total Body Lean Mass [ Time Frame: Week 52 ]
    Change from baseline in total body lean mass (as assessed by dual-energy x ray absorptiometry [DXA]) at Week 52

  4. Evaluate serum IGF-1 and IGF-1 SDS [ Time Frame: Week 52 ]
    To evaluate the pharmacodynamics (PD) of once-weekly lonapegsomatropin in adults with growth hormone deficiency

  5. Evaluate serum hGH, lonapegsomatropin, and mPEG levels [ Time Frame: Week 52 ]
    To evaluate the pharmacokinetics (PK) of once-weekly lonapegsomatropin in adults with growth hormone deficiency



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05171855


Contacts
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Contact: Michael Beckert, MD +49 (172) 155 2596 mb@ascendispharma.com
Contact: Katherine A Triana, MD, MSCR +1 (650) 374-7564 kae@ascendispharma.com

Locations
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United States, Nevada
Ascendis Pharma Investigational Site Recruiting
Las Vegas, Nevada, United States, 89148
Sponsors and Collaborators
Ascendis Pharma Endocrinology Division A/S
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Responsible Party: Ascendis Pharma Endocrinology Division A/S
ClinicalTrials.gov Identifier: NCT05171855    
Other Study ID Numbers: TCH-306EXT
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ascendis Pharma A/S ( Ascendis Pharma Endocrinology Division A/S ):
Human Growth Hormone
hGH
rhGH
GHD
Adult Growth Hormone Deficiency
Long Acting Growth Hormone
Lonapegsomatropin
Prodrug
Growth Hormone Replacement Therapy
Sustained Release Growth Hormone
Growth Hormone Deficiency
TransCon hGH
Skytrofa
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases