Adult Growth Hormone DeficiencyPhase 2NCT02946606
A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9
A Phase 2 study testing GX-H9 and Genotropin in people with Adult Growth Hormone Deficiency, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- GX-H9 and Genotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to 30 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must meet all of the following criteria to be enrolled in this study:
- 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.
- 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)
- 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.
Show all 12Show fewer
- 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.
- Has a BMI of ≥18.0 and 35.0 kg/m2 (both male and female subjects).
- Has a confirmed negative test result for anti-recombinant human growth hormone (anti-rhGH) antibodies at screening.
- 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.
- Female subjects must have a negative serum pregnancy test result at screening.
- Must be willing and able to provide written informed consent before performing any study procedures.
Who cannot join
- A subject meeting any of the following criteria will be excluded from the study:
- 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).
- 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.
- Has any clinically significant electrocardiogram (ECG) abnormality at screening.
- Has evidence of intracranial hypertension at screening.
- Has uncontrolled diabetes mellitus with diet and exercise, as determined based on glycated hemoglobin (HbA1c) levels ≥7.0% at screening.
Show all 22Show fewer
- Has impaired liver function defined as elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 × upper limit of normal (ULN).
- Has impaired kidney function defined as increased serum creatinine levels greater than 1.5 × ULN.
- Has had active acromegaly within 18 months before screening.
- Has active carpal tunnel syndrome.
- Has Prader-Willi syndrome.
- Has had active Cushing syndrome within 12 months before screening.
- 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.
- Has been treated with systemic corticosteroids other than replacement therapy within 3 months before screening.
- Is a female subject of childbearing potential who is pregnant, breastfeeding, or intends to become pregnant.
- 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.
- Has a history of noncompliance with medications, uncooperativeness, or alcohol/drug abuse.
- Has a positive result from serology examination for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has a known or suspected hypersensitivity to rhGH.
- Has donated blood or had any major blood loss greater than 500 mL within 90 days before screening.
- 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.
- Has received an investigational drug or product or has participated in a drug study within 60 days before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- GX-H9, Genotropin
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-H9Drug
Human growth hormone
GenotropinDrug
Human growth hormone
| Study group | Role | What they receive |
|---|---|---|
| Group 1: GX-H9 + Genotropin | Experimental | GX-H9 (weekly dose), Genotropin (daily) Receives: Drug: GX-H9; Drug: Genotropin |
| Group 2: GX-H9 + Genotropin | Experimental | GX-H9 (weekly dose), Genotropin (daily) Receives: Drug: GX-H9; Drug: Genotropin |
| Group 3: GX-H9 + Genotropin | Experimental | GX-H9 (weekly dose), Genotropin (daily) Receives: Drug: GX-H9; Drug: Genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength
Measured: 12 weeks
Secondary outcomes (23)
Pharmacokinetic (PK) profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-t
Measured: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-inf
Measured: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-tau
Measured: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Maximum serum concentration, Cmax
Measured: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: The time taken to reach the maximum concentration, Tmax
Measured: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Half-life, t1/2
Measured: 12 weeks
Pharmacodynamic (PD) profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGF-1, Cmax
Measured: 12 weeks
PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGF-1, AUC0-t
Measured: 12 weeks
PD profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGFBP-3, Cmax
Measured: 12 weeks
PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGFBP-3, AUC0-t
Measured: 12 weeks
Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product
Measured: 12 weeks
Immunogenicity Test After subcutaneous injection of GX-H9
Measured: 12 weeks
The changes of glucose metabolism indices
Measured: 12 weeks
Data in hormonal status of thyroid, estradiol(female), testosterone(male), and cortisol levels
Measured: 12 weeks
The lipid parameters as actual values and percent change from baseline (CFB)at week 12: total cholesterol
Measured: change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: High-density lipoprotein cholesterol
Measured: change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: low-density lipoprotein cholesterol
Measured: change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: Triglycerides
Measured: change from baseline at 12weeks
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: lipoprotein[a]
Measured: change from baseline at 12weeks
The waist circumference as actual values and CFB at week 12
Measured: change from baseline at 12weeks
The hip circumference as actual values and CFB at week 12
Measured: change from baseline at 12weeks
The waist-to-hip ratio as actual values and CFB at week 12
Measured: change from baseline at 12weeks
The BMI as actual values and CFB at week 12
Measured: change from baseline at 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startJan 2015
- Primary completion30 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eun Jig Lee, MD, PhD, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946606
- Sponsor's protocol ID
- GX-H9-002
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2015
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02946606
- Acronym / sponsor ID
- GX-H9-002
- Conditions
- Adult Growth Hormone Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: GX-H9 + Genotropin | Experimental | Drug: GX-H9, Drug: GenotropinGX-H9 (weekly dose), Genotropin (daily) |
| Group 2: GX-H9 + Genotropin | Experimental | Drug: GX-H9, Drug: GenotropinGX-H9 (weekly dose), Genotropin (daily) |
| Group 3: GX-H9 + Genotropin | Experimental | Drug: GX-H9, Drug: GenotropinGX-H9 (weekly dose), Genotropin (daily) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- Has documented confirmation (medical history) of GH deficiency during adulthood by 1 or more growth hormone (GH) stimulation tests, as follows:
- 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.
- 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.
- Has a BMI of ≥18.0 and 35.0 kg/m2 (both male and female subjects).
Key exclusion criteria (22 listed)
- 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).
- 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.
- Has any clinically significant electrocardiogram (ECG) abnormality at screening.
- Has evidence of intracranial hypertension at screening.
- Has uncontrolled diabetes mellitus with diet and exercise, as determined based on glycated hemoglobin (HbA1c) levels ≥7.0% at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-H9Human growth hormone | Drug | Group 1: GX-H9 + Genotropin, Group 2: GX-H9 + Genotropin, Group 3: GX-H9 + Genotropin |
| GenotropinHuman growth hormone | Drug | Group 1: GX-H9 + Genotropin, Group 2: GX-H9 + Genotropin, Group 3: GX-H9 + Genotropin |
Primary outcome
The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength
Time frame: 12 weeks
23 secondary outcomes
Pharmacokinetic (PK) profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-t
Time frame: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-inf
Time frame: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Area under the curve, AUC0-tau
Time frame: 12 weeks
PK profile of GX-H9 in the treatment of AGHD: Maximum serum concentration, Cmax
Time frame: 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
PK profile of GX-H9 in the treatment of AGHD: Half-life, t1/2
Time frame: 12 weeks
Pharmacodynamic (PD) profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGF-1, Cmax
Time frame: 12 weeks
PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGF-1, AUC0-t
Time frame: 12 weeks
PD profile of GX-H9 in the treatment of AGHD: Maximum serum concentration of IGFBP-3, Cmax
Time frame: 12 weeks
PD profile of GX-H9 in the treatment of AGHD: Area under curve of IGFBP-3, AUC0-t
Time frame: 12 weeks
Data in Physical examination, Vital signs, Electrocardiography, Clinical Laboratory Test Results Related to Investigational Product
Time frame: 12 weeks
Immunogenicity Test After subcutaneous injection of GX-H9
Time frame: 12 weeks
The changes of glucose metabolism indices
Time frame: 12 weeks
Data in hormonal status of thyroid, estradiol(female), testosterone(male), and cortisol levels
Time frame: 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
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
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
The lipid parameters as actual values and percent change from baseline (CFB) at week 12: Triglycerides
Time frame: 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
The waist circumference as actual values and CFB at week 12
Time frame: change from baseline at 12weeks
The hip circumference as actual values and CFB at week 12
Time frame: 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
The BMI as actual values and CFB at week 12
Time frame: change from baseline at 12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Adult Growth Hormone Deficiency
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Recruiting
BELux Children OutcoME During A(@)Dulthood With GHD
Growth Hormone Deficiency, Adult Growth Hormone Deficiency
RecruitingObservational study
Charactertizing Growth Hormone Deficiency in Traumatic Brain Injury
Growth Hormone Deficiency, Traumatic Brain Injury
RecruitingPhase 2
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
Adult Growth Hormone Deficiency
Enrolling by invitationObservational study
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
Adult Growth Hormone Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Jig Lee, MD, PhD principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GX-H9 and Genotropin in people with Adult Growth Hormone Deficiency, run by Genexine, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.