Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
Sponsored by Versartis Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Female participants of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
- Documented GHD during adulthood
- Participants naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening
- Participants taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months
- Underlying disorders responsible for the participant's GHD must have been clinically stable for at least 6 months
- Participants receiving daily rhGH injections must washout for ≥ 14 days
- Body mass index (BMI) (kilograms [kg]/meter square [m^2]) between 18.0 and 40.0
Exclusion Criteria
- Untreated adrenal insufficiency
- Recently diagnosed thyroid dysfunction which is not being treated or has not been stable on therapy for at least 3 months
- Currently taking anti-inflammatory dose of glucocorticoids that could potentially compromise safety or efficacy assessments
- Currently taking a GHRH or IGF-I product
- Current significant cardiovascular disease, heart insufficiency of New York Heart Association (NYHA) class > 2
- Current significant disease thought to increase risk of receiving growth hormone or confound assessment of study outcomes
- History of diabetes mellitus or inadequate glucose control
- Current drug or alcohol abuse
- Current human immunodeficiency virus (HIV) wasting syndrome (HIV testing not required)
- History of malignancy in adulthood (participants with a history of childhood malignancy that were subsequently treated with rhGH in childhood and remain GHD in adulthood may be enrolled)
- Women who are pregnant or breastfeeding
- Treatment with an investigational drug other than somavaratan within 30 days prior to Screening
- A significant abnormality in Screening laboratory results