Treatment of Adults With Growth Hormone Deficiency

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency.

The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.

Study Overview

• Status: Completed
• Conditions: Adult Growth Hormone Deficiency; Pituitary Disorders
• Intervention / Treatment: Drug: growth hormone

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States
      • Oregon Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female of at least 23 years and not more than 70 years of age
• GHD of either adult onset(AO)or Childhood onset(CO), either idiopathic or secondary to pituitary disease
• Confirmed diagnosis of GHD defined
• IGF-1 SDS ≤ -1 at screening
• No exposure to rhGH within the last 6 months
• Patients with adequate adrenal function, which is confirmed by ACTH stimulation test at screening; or Patients with known secondary hypoadrenalism on adequate glucocorticoid replacement therapy
• If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 3 months before study entry
• Women of child-bearing potential to be using a reliable method of contraception at the screening and be willing to use it throughout the study
• A negative serum pregnancy test is required at screening for females of child-bearing potential.

Exclusion Criteria:

• History of malignancy other than cranial tumor or leukemia causing GHD or fully treated basal cell carcinoma
• Evidence of active malignancy
• Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 12 months
• Significant hepatic dysfunction
• Chronic renal impairment
• Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease
• Prader-Willi syndrome
• Acute severe illness in the last 6 months
• Benign intracranial hypertension
• Active Cushing's syndrome within the last 12 months
• Uncontrolled hypertension
• Patients with overt diabetes mellitus or evidence of persistent impaired glucose tolerance
• Severe psychiatric disease or patients who cannot understand the objective and methods of the study or patients with current alcohol abuse
• Pregnancy or lactation
• Known hypersensitivity to any ingredient of the study drug
• Inability to undergo scanning by dual-energy X ray absorptiometry (DXA) due to a body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning
• Weight reducing drugs or appetite suppressants
• Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry
• Methylphenidate within 2 months before study entry
• Systemic corticosteroids other than in replacement doses within the 3 months before study entry.
• History of non-compliance with medications, un-cooperativeness or drug abuse
• Patients participating in another study parallel to, or within 6 months prior to study entry, or previous participation in this study
• Patients who are not able to comply with the study protocol for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: growth hormone; subcutaneous injection, once-weekly
Experimental: LB03002	Drug: growth hormone; subcutaneous injection, once-weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Fat Mass at the end of 26-week treatment from baseline	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in the following parameters at the end of 26-week treatment from baseline; other body composition parameters, QoL Score, Serum IGF-I, IGFBP-3 levels & SDS, Lipid profile, waist-to-hip ratio	26 weeks

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Collaborators: BioPartners GmbH
• Investigators: Study Chair: HJ Ji, PhD, LG Life Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: February 20, 2006
• First Submitted That Met QC Criteria: February 20, 2006
• First Posted (Estimate): February 22, 2006

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Growth hormone deficiency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Pituitary Diseases; Dwarfism, Pituitary; Endocrine System Diseases; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: BPLG-005