An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)

15VR8

Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).

2016-02-11

2018-01-11

2018-01-11

Terminated

Early phase I

36

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2023-04-13