A multicentre, multinational, randomized, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin FlexPro in adults with growth hormone deficiency for 35 weeks, with a 53-week extension period
A study for adults with growth hormone deficiency using study drug NNC0195-0092
Sponsor: Novo Nordisk AVS
Enrolling: Male and Female Patients
IRB Number: AAAO2553
U.S. Govt. ID: NCT02229851
Contact: Pamela Freda: 212-305-2254 / puf1@cumc.columbia.edu
Additional Study Information: The purpose of this study is to investigate how well weekly injections of the growth hormone drug NNC0195-0092 works in adults with growth hormone deficiency. Growth hormone deficiency is a disorder that involves the pituitary gland (a small gland located at the base of the brain). The gland produces growth hormone and other hormones (chemical messengers of the body). In children, growth will be slower than normal when lower levels of growth hormone are produced. In adults, growth hormone is needed to maintain the right distribution of body fat, muscle and bone. A low level or absence of growth hormone can also cause emotional symptoms such as tiredness and lack of motivation in adults. NNC0195-0092 is a new growth hormone drug developed to have a relatively long effect in the body and is currently under investigation for once-weekly administration. NNC0195-0092 has been tested in several other clinical trials where it has been safe and well tolerated. This study will also examine whether the drug is safe and effective for use.
This study is closed
Pamela Freda, MD
Do You Qualify?
Do you have an active malignant disease or history of malignancy? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Pamela Freda