A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

Adult Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01909479
• Other study ID #: CP-4-005
• Secondary ID: 2013-000830-37
• Status: Terminated
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2022
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 202
• Est. completion date: August 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases

Intervention

Drug:
• MOD-4023
Individualized once weekly dose of MOD-4023

Other:
• Placebo
Once weekly administration of placebo

Locations

Country	Name	City	State
Israel	Opko Biologics	Kiryat Gat

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26		Baseline to 26 weeks
Secondary	Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26		Baseline to 26 weeks
Secondary	Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26		Baseline to 26 weeks
Secondary	Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks		Baseline to 52 weeks
Secondary	Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks		26 weeks to 52 weeks
Secondary	Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26		Baseline to 26 weeks
Secondary	Change in Biochemical Marker IGF-1		Baseline to 26 weeks