A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
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|ClinicalTrials.gov Identifier: NCT01909479|
Recruitment Status : Terminated (Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated.)
First Posted : July 26, 2013
Results First Posted : August 12, 2022
Last Update Posted : August 12, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Adult Growth Hormone Deficiency||Drug: MOD-4023 Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||June 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2018|
Individualized once weekly dose of MOD-4023
|Placebo Comparator: Placebo||
Once weekly administration of placebo
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26 [ Time Frame: Baseline to 26 weeks ]
- Change in Biochemical Marker IGF-1 [ Time Frame: Baseline to 26 weeks ]
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|Ages Eligible for Study:||23 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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): NCT01909479
|Kiryat Gat, Israel, 8211804|
|Responsible Party:||OPKO Health, Inc.|
|Other Study ID Numbers:||
2013-000830-37 ( EudraCT Number )
|First Posted:||July 26, 2013 Key Record Dates|
|Results First Posted:||August 12, 2022|
|Last Update Posted:||August 12, 2022|
|Last Verified:||August 2022|
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