This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

15VR8

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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