Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Growth Hormone Deficiency
• Age: Between 23 years - 75 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Adult growth hormone deficiency (AGHD) Diagnosis Criteria
  2. Participants who are hGH treatment-naïve or no exposure to hGH therapy or GH secretagogue for at least 12 months prior
  3. For participants on hormone replacement therapies for any hormone deficiencies other than GH (eg, adrenal, thyroid, estrogen, testosterone) must be on adequate and stable doses for =6 weeks prior to and throughout screening
  4. For participants not on glucocorticoid replacement therapy, documentation of adequate adrenal function at screening
  5. On a stable diet and exercise regime at screening with no intention to modify diet or exercise pattern during the trial
  6. No plans to undergo bariatric surgery during the trial
  7. Able and willing to provide a written Informed Consent Form

  
  

You may not be eligible for this study if the following are true:

• 1. Known Prader-Willi Syndrome and/or other genetic diseases that may have an impact on an endpoint
  2. Diabetes mellitus not controlled and at goal at screening
  3. Active malignant disease or history of malignancy
  4. Evidence of growth of pituitary adenoma or other benign intracranial tumor within the last 12 months
  5. Participants with acromegaly without remission / with documented remission less than 24 months
  6. Participants with Cushing’s disease without remission / with documented remission less than 24 months
  7. Participants with prior cranial irradiation or hypothalamic-pituitary surgery: the procedure took place less than 12 months
  8. Heart failure NYHA class 3 or greater
  9. Poorly controlled hypertension
  10. Cerebrovascular accident within 5 years prior
  11. Anabolic steroids
  12. Currently using or have used within 26 weeks prior to screening any weight-loss or appetite-suppressive medications
  13. Known history of hypersensitivity and/or idiosyncrasy to any of the test compounds
  14. Known history of neutralizing anti-hGH antibodies
  15. Female who is pregnant, breast-feeding or intends to become pregnant
  16. Male subjects must use a condom, or his female partner of childbearing potential must use an effective form of contraception as described above, from the beginning of screening to the last trial visit
  17. Known substance abuse or known eating disorders
  18. Any disease or condition that, in the judgement of the investigator, may make the subject unlikely to comply with the requirements of the trial
  19. Participation in another interventional clinical trial involving an investigational compound