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Growth Hormone Receptor Agonist

Somavaratan for Human Growth Hormone Deficiency

Phase 3
Waitlist Available
Research Sponsored by Versartis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This study is a multi-center, open-label safety study assessing long-term somavaratan administration.

Eligible Conditions
  • Human Growth Hormone Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
Height velocity
IGF-I expression
Immunogenicity

Side effects data

From 2017 Phase 3 trial • 138 Patients • NCT02339090
17%
Pyrexia
17%
Injection site pain
15%
Headache
14%
Cough
12%
Upper respiratory tract infection
12%
Vomiting
12%
Pain in extremity
11%
Arthralgia
7%
Nasopharyngitis
7%
Otitis media
7%
Oropharyngeal pain
7%
Diarrhoea
6%
Ear infection
6%
Injection site haematoma
5%
Nausea
2%
Arnold-Chiari malformation
2%
Nasal congestion
2%
Hypothyroidism
1%
Adrenal insufficiency
1%
Syringomyelia
1%
Glomerulonephritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Somavaratan
rhGH

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SomavaratanExperimental Treatment1 Intervention
fusion protein, subcutaneous bolus injection, 3.5 mg/kg twice monthly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somavaratan
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Versartis Inc.Lead Sponsor
7 Previous Clinical Trials
750 Total Patients Enrolled
1 Trials studying Human Growth Hormone Deficiency
50 Patients Enrolled for Human Growth Hormone Deficiency
Will Charlton, MDStudy DirectorVesrartis
6 Previous Clinical Trials
682 Total Patients Enrolled
~2 spots leftby Dec 2025
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