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Versartis Is Committed to Developing Somavaratan to Address Unmet Patient Needs.

Versartis’ mission is focused on developing, manufacturing and commercializing novel therapeutics to improve and transform treatment for patients with endocrine disorders.

Central to our development efforts is sound scientific and clinical research to evaluate the potential benefit for people with endocrine diseases. Through our ongoing clinical trials, we endeavor to better understand our investigational drugs and, if supported by the data, to ultimately seek regulatory approval for new medications to advance patient care. Our current clinical trial efforts are focused on developing somavaratan (VRS-317), a twice-monthly, long-acting form of growth hormone for children and adults with growth hormone deficiency, or GHD.

For additional information about current ongoing Versartis clinical trials, hover over a trial logo below.

Vista

Status: Currently enrolling pediatric patients with GHD in the United States and Europe.
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The Versartis Long-Term Safety Study of Somavaratan (VISTA) is a multi-center, open-label study assessing long-term somavaratan administration. It is open to pediatric patients completing a somavaratan study in growth hormone deficiency (GHD), as well as new pediatric patients with GHD. All patients will receive somavaratan 3.5 mg/kg twice monthly.
The trial is being conducted in the United States, Canada and Europe.

j14vr5

Status: Currently Enrolling Phase 3 Treatment-Naïve Pediatric Patients with GHD in Japan.
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The J14VR5 trial is a randomized, open-label, Phase 2/3, multi-center trial of somavaratan (VRS-317) in pre-pubertal Japanese children with GHD.
The trial is being conducted in Japan.

15vr8

Status: Currently Enrolling Adult Patients with GHD in the United States and Australia.
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The 15VR8 trial is an open-label, long-term safety study to evaluate the safety of somavaratan in adults with GHD. Enrollment is open to adult patients with GHD completing the Versartis Phase 2 trial (VITAL), as well as new adult patients with GHD.
The trial is being conducted in the United States and Australia.

Velocity

Status: Enrollment Completed.
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The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Trial is a randomized, one-year, open-label, multi-center, Phase 3 registration trial exploring somavaratan (VRS-317) in pre-pubertal children with GHD.
The trial is being conducted in the United States, Canada and Europe.

If you are interested in participating in a Versartis clinical trial, please email clinicaloperations@versartis.com. If you are already participating in a Versartis clinical trial and have any questions or wish to report a problem with the study drug or side effect(s), please contact your study doctor as soon as possible.

Versartis is committed to providing sound clinical evidence to establish somavaratan’s potential effectiveness and safety in patients with GHD, and has previously completed a number of clinical studies.

Completed Somavaratan Trials

Phase 1a (11VR1.1) – Adult GHD Single ascending dose trial – First in-human trial of somavaratan
Phase 1b/2a (12VR2 or “VERTICAL” Trial) – Pediatric GHD dose finding and 6-month efficacy trial
Phase 2 (15VR7 or “VITAL” Trial) – Adult GHD dose-finding safety study