A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
Primary Purpose
Adult Growth Hormone Deficiency
Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
MOD-4023
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Adult Growth Hormone Deficiency
Eligibility Criteria
Inclusion Criteria:
- Men and women between the age of 23 to 70 years old at screening, inclusive
- GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
- No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
- The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
- Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
- Subject had a DXA screening and the results are interpretable according to the study plan.
Exclusion Criteria:
- Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
- Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
- History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
- Signs of intracranial hypertension at screening
- Heart insufficiency, NYHA class > 2 (Appendix B)
- History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
- History of Acromegaly
Sites / Locations
- Opko Biologics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MOD-4023
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Secondary Outcome Measures
Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
Change in Biochemical Marker IGF-1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01909479
Brief Title
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
Official Title
A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product (MOD-4023) In Adult Subjects With Growth Hormone Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated.
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Growth Hormone Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOD-4023
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MOD-4023
Intervention Description
Individualized once weekly dose of MOD-4023
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Once weekly administration of placebo
Primary Outcome Measure Information:
Title
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time Frame
Baseline to 26 weeks
Secondary Outcome Measure Information:
Title
Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time Frame
Baseline to 26 weeks
Title
Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time Frame
Baseline to 26 weeks
Title
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
Time Frame
Baseline to 52 weeks
Title
Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
Time Frame
26 weeks to 52 weeks
Title
Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
Time Frame
Baseline to 26 weeks
Title
Change in Biochemical Marker IGF-1
Time Frame
Baseline to 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women between the age of 23 to 70 years old at screening, inclusive
GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
Subject had a DXA screening and the results are interpretable according to the study plan.
Exclusion Criteria:
Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
Signs of intracranial hypertension at screening
Heart insufficiency, NYHA class > 2 (Appendix B)
History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
History of Acromegaly
Facility Information:
Facility Name
Opko Biologics
City
Kiryat Gat
ZIP/Postal Code
8211804
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
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