Summary of somavaratan clinical trial program

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Somavaratan clinical trial programs

Investigating the potential of a long-acting form of recombinant human growth hormone for growth hormone deficiency

Building a strong foundation of data to improve GHD treatment approaches

Versartis is committed to developing solutions to address the unmet needs of patients with GHD. By minimizing the treatment burden associated with current growth hormone injections, the goal is to transform the treatment paradigm for patients with GHD.

Versartis designed the somavaratan clinical trial program to:

  • Build a deep and broad foundation of data focusing on patients with GHD
  • Evaluate somavaratan as a twice-monthly treatment for GHD1,2
  • Be representative of the patients that many endocrinologists see in clinical practice in the United States today by recruiting children with moderate GHD for the pediatric trials2,3

For more information about the eligibility criteria and stratification procedures in our pediatric GHD trials, click here.

Pediatric GHD

Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH (VELOCITY)

  • VELOCITY is a phase 3 trial comparing the safety and efficacy of somavaratan with daily rhGH over 12 months of treatment
  • Dose selection for somavaratan in VELOCITY was supported by results of earlier trials2
  • Treatment adherence was monitored using an electronic, patient-reported outcome system (eDiary, Bracket, Inc)
  • Enrollment completed; top-line data: September 2017

Design: randomized, open-label, multicenter, noninferiority study


Chart

After 12 months, all participants in the VELOCITY trial are eligible to enroll in a long-term safety study of somavaratan called VISTA. Learn more about the VISTA trial in the next section.

View full study at clinicaltrials.gov

Versartis Long-Term Safety Study of Somavaratan (VISTA)

  • VISTA is a multicenter, open-label study assessing long-term safety of somavaratan administration in pediatric patients with GHD
  • VISTA is open to patients rolling over from the prior phase 2a trial and patients rolling over from VELOCITY, as well as new treatment-naïve subjects with GHD
  • Study is ongoing—patients from phase 2a are currently entering 4th year of total somavaratan exposure

Design: open-label, multicenter, safety study


Chart

See poster by Miller et al, presented at ECE 2017

View full study at clinicaltrials.gov

Somavaratan is an investigational new drug that has not been approved for sale in any country.

References
1. Yuen KCJ, Biller BMK, Rogoff D, et al. Somavaratan, a long-acting recombinant human growth hormone, for the treatment of adults with growth hormone deficiency: results of VITAL, an open-label, dose-finding, international, phase 2 study (NCT02526420). Presented at: Endocrine Society Annual Meeting; April 1-4, 2017; Orlando, FL.
2. Moore WV, Fechner PY, Nguyen HJ, et al. Safety and efficacy of somavaratan (VRS-317), a long-acting rhGH, in children with growth hormone deficiency (GHD): 3-year update of the VERTICAL and VISTA trials (NCT01718041, NCT02068521). Presented at: Endocrine Society Annual Meeting; April 1-4, 2017; Orlando, FL.
3. Versartis reports new data on long-acting somavaratan in growth hormone deficiency at ENDO 2017 [press release]. Menlo Park, CA: Versartis, Inc.; April 3, 2017. http://ir.versartis.com/releasedetail.cfm?ReleaseID=1019742&corpSection=IR. Accessed July 26, 2017.