5446W-13 A phase 3, multicenter study designed to evaluate the efficacy and safety of a long-acting

A phase 3, multicenter study designed to evaluate the efficacy and safety of a long-acting hGH product (MOD-4023) in adult subjects with growth hormone deficiency

Type of Study
Neuroscience - Growth Hormone Deficiency
Short Description
Growth Hormone Deficiency (GHD) is caused by the insufficient secretion of naturally produced human growth hormone (hGH).  MOD-4023 has the same active ingredient as the natural growth hormone from the body, but has been slightly changed so that its action in the body lasts longer, and therefore can be given by subcutaneous injections weekly instead of daily, which is the current standard of care.

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).
 
Status
Open
Principal Investigator
Frances Broyles, MD
Eligibility Notes
  • Male and female patients age 23 to 70, inclusive
  • Confirmed diagnosis of growth hormone deficiency
  • Body Mass Index (BMI) of 23.0 to 35.0 kg/m2, inclusive
  • Patients with a history of any cancer are not eligible for this study
Contact Name
Becky Wood & Lauren Lennox
Phone
206-320-7115
Alternate Phone
206-320-2563
Email
Becky.wood@swedish.org
Alternate Email
Lauren.lennox@swedish.org