Adult Growth Hormone Deficiency (AGHD)Phase 2NCT02719990
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
A Phase 2 study testing somavaratan in people with Adult Growth Hormone Deficiency (AGHD), run by Versartis Inc..
Trial summary
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adult Growth Hormone Deficiency (AGHD)
- What is being tested?
- somavaratan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2016to 11 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
Read the detailed description
An open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with GHD. This multicenter study is open to participants completing a Versartis adult GHD study as well as approximately 40 new somavaratan naïve participants (either recombinant human growth hormone [rhGH] treatment naïve or currently receiving daily rhGH therapy). All participants will receive twice-monthly (every 15 days ± 2 days) subcutaneous (SC) somavaratan. Doses will be titrated to each participant's individual insulin-like growth factor-I (IGF-I) responses based on the IGF-I level 7 days post-dose until a maintenance dose is achieved. Participants receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 milligrams [mg], 40 mg for women on estrogen, rounded down to the nearest even number) and will be titrated per the Dose Titration Plan. New participants enrolling in this study will be assigned to one of two cohorts based on sensitivity to rhGH and titrated per the Dose Titration Plan.
- Conditions
- Adult Growth Hormone Deficiency (AGHD)
- Being tested
- somavaratan
- Keywords
- VRS-317, Long Acting Growth Hormone, Versartis, somavaratan, Growth Hormone Deficiency, Adult Growth Hormone Deficiency, AGHD, Growth Hormone Replacement, Growth Hormone Replacement Therapy, XTEN
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somavaratanDrug
Also called VRS-317
Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly
| Study group | Role | What they receive |
|---|---|---|
| Somavaratan | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult participants with GHD Receives: Drug: somavaratan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Measured: From first dose of study drug up to approximately 2 years
Secondary outcomes (6)
Average Dose Level During Titration/Maintenance
Total average dose received by a participant during titration/maintenance has been reported.
Measured: Up to Month 12
Number of Participants With Dose Adjustments
The number of participants with a dose adjustment (titrated up/down) at each month are summarized.
Measured: Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Number of Participants Who Were Anti-drug Antibody (ADA) Positive
Measured: Up to approximately 2 years
Number of Participants With Positive Neutralizing Antibodies (NABs)
Measured: Up to approximately 2 years
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Changes in the IGF-I levels were assessed as Standard Deviation Scores (SDS). The SDS was calculated as the actual value of IGF-I minus mean reference value of IGF-1 divided by reference standard deviation of IGF-I. The mean and the standard deviation (SD) vary depending on the age and sex of the participant. Change in IGF-I level (SDS) at specified timepoints from baseline was assessed. A higher score reflects a better outcome.
Measured: Baseline, Month 2 Day 1, Month 2 Day 8, Month 3 Day 1, Month 3 Day 8, Month 4 Day 1, Month 4 Day 8, Month 5 Day 1, Month 5 Day 8, Month 6 Day 1, Month 6 Day 8, Month 7 Day 1, Month 7 Day 8, Month 8 Day 1, Month 8 Day 8, Month 10 Day 1, and Month 10 Day 8
Mean Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) SDS During Maintenance Period
Measured: Baseline up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start11 Feb 2016
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Why it stopped: Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (PGHD) did not meet its primary endpoint of non-inferiority.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Growth Hormone Deficiency (AGHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versartis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Will Charlton, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719990
- Sponsor's protocol ID
- 15VR8
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2016
- Last updated
- 13 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)
- ClinicalTrials.gov ID
- NCT02719990
- Acronym / sponsor ID
- 15VR8
- Conditions
- Adult Growth Hormone Deficiency (AGHD)
- Keywords
- VRS-317, Long Acting Growth Hormone, Versartis, somavaratan, Growth Hormone Deficiency, Adult Growth Hormone Deficiency, AGHD, Growth Hormone Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (PGHD) did not meet its primary endpoint of non-inferiority.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Versartis Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 13 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
Detailed description
An open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with GHD. This multicenter study is open to participants completing a Versartis adult GHD study as well as approximately 40 new somavaratan naïve participants (either recombinant human growth hormone [rhGH] treatment naïve or currently receiving daily rhGH therapy). All participants will receive twice-monthly (every 15 days ± 2 days) subcutaneous (SC) somavaratan. Doses will be titrated to each participant's individual insulin-like growth factor-I (IGF-I) responses based on the IGF-I level 7 days post-dose until a maintenance dose is achieved. Participants receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 milligrams [mg], 40 mg for women on estrogen, rounded down to the nearest even number) and will be titrated per the Dose Titration Plan. New participants enrolling in this study will be assigned to one of two cohorts based on sensitivity to rhGH and titrated per the Dose Titration Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somavaratan | Experimental | Drug: somavaratanLong-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult participants with GHD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somavaratanAlso: VRS-317Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly | Drug | Somavaratan |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: From first dose of study drug up to approximately 2 years
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
6 secondary outcomes
Average Dose Level During Titration/Maintenance
Time frame: Up to Month 12
Number of Participants With Dose Adjustments
Time frame: Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Number of Participants Who Were Anti-drug Antibody (ADA) Positive
Time frame: Up to approximately 2 years
Number of Participants With Positive Neutralizing Antibodies (NABs)
Time frame: Up to approximately 2 years
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Time frame: Baseline, Month 2 Day 1, Month 2 Day 8, Month 3 Day 1, Month 3 Day 8, Month 4 Day 1, Month 4 Day 8, Month 5 Day 1, Month 5 Day 8, Month 6 Day 1, Month 6 Day 8, Month 7 Day 1, Month 7 Day 8, Month 8 Day 1, Month 8 Day 8, Month 10 Day 1, and Month 10 Day 8
Mean Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) SDS During Maintenance Period
Time frame: Baseline up to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Will Charlton, MD study director
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing somavaratan in people with Adult Growth Hormone Deficiency (AGHD), run by Versartis Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: From first dose of study drug up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.