A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9

September 4, 2017 updated by: Genexine, Inc.

A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD)

This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of GX-H9 in the treatment of AGHD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The subjects who are adequately eligible to attend this clinical trial via screening will be sequentially assigned starting with Group 1. Each group will be comprised of subjects who will receive both GX-H9 and Genotropin, and subjects will be randomly assigned to either GX-H9 and Genotropin in the ratio of 4:1. The treatment will proceed as the proposed group order (Group 1, Group 2, Group 3), and safety and insulin-like growth factor (IGF-1) will be reviewed six weeks after each treatment by the safety monitoring committees before proceeding to the next group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Each subject must meet all of the following criteria to be enrolled in this study:

  1. Is a male or female aged ≥20 and 65 years with AGHD, either adult onset GHD due to hypothalamic pituitary disease or childhood onset GHD that is either idiopathic or due to hypothalamic pituitary disease or due to genetic causes.

  2. Has documented confirmation (medical history) of GH deficiency during adulthood by 1 or more growth hormone (GH) stimulation tests, as follows:

    • Insulin tolerance test (peak hGH≤3.0 ng/mL)
    • Arginine + growth-hormone-releasing hormone (peak hGH≤4.0 ng/mL)
  3. Has been treated with stable hormonal replacement therapies for deficiencies of other hypothalamo pituitary axes and must have been on an optimized and stable treatment regimen for at least 3 months before screening (free thyroxine [T4] level within normal range at screening). Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable.
  4. Has a screening IGF-1 level of at least 1 standard deviation (SD) score (IGF-1 SD score <1) below the mean IGF-1 level standardized for age and gender according to the central laboratory reference values.
  5. Has a BMI of ≥18.0 and 35.0 kg/m2 (both male and female subjects).
  6. Has a confirmed negative test result for anti-recombinant human growth hormone (anti-rhGH) antibodies at screening.
  7. Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 6 months after the last dose of study drug.
  8. Female subjects must have a negative serum pregnancy test result at screening.
  9. Must be willing and able to provide written informed consent before performing any study procedures.

Exclusion Criteria:

A subject meeting any of the following criteria will be excluded from the study:

  1. Has evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months which has to be confirmed by computed tomography or magnetic resonance imaging scan (with contrast) within 3 months before screening. (Subjects with inactive remnant intracranial tumors are eligible).
  2. Is currently receiving antitumor therapy and has a history of malignancy other than i) cranial tumor or leukemia causing GHD, or ii) fully treated basal cell carcinoma or evidence of active malignancy.
  3. Has any clinically significant electrocardiogram (ECG) abnormality at screening.
  4. Has evidence of intracranial hypertension at screening.
  5. Has uncontrolled diabetes mellitus with diet and exercise, as determined based on glycated hemoglobin (HbA1c) levels ≥7.0% at screening.
  6. Has impaired liver function defined as elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 × upper limit of normal (ULN).
  7. Has impaired kidney function defined as increased serum creatinine levels greater than 1.5 × ULN.
  8. Has had active acromegaly within 18 months before screening.
  9. Has active carpal tunnel syndrome.
  10. Has Prader-Willi syndrome.
  11. Has had active Cushing syndrome within 12 months before screening.
  12. Has any other major medical conditions, including eg, clinically manifested hypertension, tuberculosis, major surgery within the 3 months before screening, or significantly abnormal laboratory test results (eg, disturbed calcium homeostasis); or any other conditions (eg, acute infections) that may influence drug absorption, metabolism, or excretion, or that may interfere with any study variables in the judgment of the investigator.
  13. Has been treated with systemic corticosteroids other than replacement therapy within 3 months before screening.
  14. Is a female subject of childbearing potential who is pregnant, breastfeeding, or intends to become pregnant.
  15. Has been treated with anabolic steroids other than gonadal steroid replacement therapy within 2 months before screening. Oral estrogen replacement and hormonal contraceptives are not allowed in female subjects. For replacement purposes, transdermal estrogens are permitted in female subjects.
  16. Has a history of noncompliance with medications, uncooperativeness, or alcohol/drug abuse.
  17. Has a positive result from serology examination for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  18. Has a known or suspected hypersensitivity to rhGH.
  19. Has donated blood or had any major blood loss greater than 500 mL within 90 days before screening.
  20. Has a history of any medical or psychiatric condition that in the opinion of the investigator would pose a risk for participation in this study or interfere with the compliance needed for this study.
  21. Has received an investigational drug or product or has participated in a drug study within 60 days before screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: GX-H9 + Genotropin
GX-H9 (weekly dose), Genotropin (daily)
Drug: GX-H9
Human growth hormone
Drug: Genotropin
Human growth hormone
Experimental: Group 2: GX-H9 + Genotropin
GX-H9 (weekly dose), Genotropin (daily)
Drug: GX-H9
Human growth hormone
Drug: Genotropin
Human growth hormone
Experimental: Group 3: GX-H9 + Genotropin
GX-H9 (weekly dose), Genotropin (daily)
Drug: GX-H9
Human growth hormone
Drug: Genotropin
Human growth hormone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetic (PK) profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-t
Time Frame: 12 weeks
12 weeks
PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-inf
Time Frame: 12 weeks
12 weeks
PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-tau
Time Frame: 12 weeks
12 weeks
PK profile of GX-H9 in the treatment of AGHD: Maximum serum concentration, Cmax
Time Frame: 12 weeks
12 weeks
PK profile of GX-H9 in the treatment of AGHD: The time taken to reach the maximum concentration, Tmax
Time Frame: 12 weeks
12 weeks
PK profile of GX-H9 in the treatment of AGHD: Half-life, t1/2
Time Frame: 12 weeks
12 weeks
Pharmacodynamic (PD) profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGF-1, Cmax
Time Frame: 12 weeks
12 weeks
PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGF-1, AUC0-t
Time Frame: 12 weeks
12 weeks
PD profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGFBP-3, Cmax
Time Frame: 12 weeks
12 weeks
PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGFBP-3, AUC0-t
Time Frame: 12 weeks
12 weeks
Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product
Time Frame: 12 weeks
12 weeks
Immunogenicity Test After subcutaneous injection of GX-H9
Time Frame: 12 weeks
12 weeks
The changes of glucose metabolism indices
Time Frame: 12 weeks
12 weeks
Data in hormonal status of thyroid, estradiol(female), testosterone(male), and cortisol levels
Time Frame: 12 weeks
12 weeks
The lipid parameters as actual values and percent change from baseline (CFB)at week 12: total cholesterol
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: High-density lipoprotein cholesterol
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: low-density lipoprotein cholesterol
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: Triglycerides
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: lipoprotein[a]
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The waist circumference as actual values and CFB at week 12
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The hip circumference as actual values and CFB at week 12
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The waist-to-hip ratio as actual values and CFB at week 12
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks
The BMI as actual values and CFB at week 12
Time Frame: change from baseline at 12weeks
change from baseline at 12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genexine, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eun Jig Lee, MD, PhD, Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GX-H9-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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