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

NCT01909479 | Terminated Phase 3 Results DMC

• 2 other identifiers: CP-4-0052013-000830-37
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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).

Conditions

Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26

  Baseline to 26 weeks

• Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26

  Baseline to 26 weeks

• Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks

  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

  26 weeks to 52 weeks

• Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26

  Baseline to 26 weeks

Study Arms (2)

MOD-4023

EXPERIMENTAL

Drug: MOD-4023

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

MOD-4023 DRUG

Individualized once weekly dose of MOD-4023

MOD-4023

Placebo OTHER

Once weekly administration of placebo

Placebo

Eligibility Criteria

• Age: 23 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Signs of intracranial hypertension at screening
• Heart insufficiency, NYHA class \> 2 (Appendix B)
• History of Acromegaly

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

Opko Biologics

Kiryat Gat, 8211804, Israel

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

MOD-4023

Condition Hierarchy (Ancestors)

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; Endocrine System Diseases

Results Point of Contact

• Title: OPKO Health Inc
• Organization: OPKO Health Inc

contact@opko.com

3055754100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2018
• Last Updated: August 12, 2022
• Results First Posted: August 12, 2022

Record last verified: 2022-08

Locations

IL (1)