Growth Hormone DisorderPhase 2NCT00715689
Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
A Phase 2 study testing NNC126-0083 in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 3 sites in Denmark.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- NNC126-0083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesDenmark
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
- Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
- GH replacement therapy for more than 3 months
- Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
Who cannot join
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Malignant disease
- Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- Heart insufficiency, NYHA class greater than 2
- Subjects with diabetes with an HbA1C above 8.0%
- Diabetic receiving insulin treatment
Show all 9Show fewer
- Stable pituitary replacement therapy for less than 3 months
- Impaired liver function
- Impaired kidney function
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
København Ø, 2100
Novo Nordisk Investigational Site
Odense, 5000
About this study
Official title: Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
- Being tested
- NNC126-0083, placebo
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC126-0083Drug
Also called pegylated long-acting human growth hormone
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Also called pegylated long-acting human growth hormone
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Also called pegylated long-acting human growth hormone
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Also called pegylated long-acting human growth hormone
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| B | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| C | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| D | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (adverse events, local tolerability, physical examination)
Measured: 0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary outcomes (1)
Cmax, maximum concentration of IGF-I
Measured: after trial product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715689
- Sponsor's protocol ID
- NN8630-1823
- Other IDs
- 2008-001061-29, 2008
- Status last verified
- Feb 2017
- First submitted
- 14 Jul 2008
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22.
PubMed 21177789
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
- ClinicalTrials.gov ID
- NCT00715689
- Acronym / sponsor ID
- NN8630-1823
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NNC126-0083, Drug: placebo |
| B | Experimental | Drug: NNC126-0083, Drug: placebo |
| C | Experimental | Drug: NNC126-0083, Drug: placebo |
| D | Experimental | Drug: NNC126-0083, Drug: placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
- Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
- GH replacement therapy for more than 3 months
- Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive
Key exclusion criteria (9 listed)
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Malignant disease
- Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- Heart insufficiency, NYHA class greater than 2
- Subjects with diabetes with an HbA1C above 8.0%
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 |
|---|---|---|
| NNC126-0083Also: pegylated long-acting human growth hormoneDose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | A |
| NNC126-0083Also: pegylated long-acting human growth hormoneDose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | B |
| NNC126-0083Also: pegylated long-acting human growth hormoneDose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | C |
| NNC126-0083Also: pegylated long-acting human growth hormoneDose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | D |
| placeboDose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | A |
| placeboDose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | B |
| placeboDose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | C |
| placeboDose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | D |
Primary outcome
Safety and tolerability (adverse events, local tolerability, physical examination)
Time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)
1 secondary outcome
Cmax, maximum concentration of IGF-I
Time frame: after trial product administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Results publication: PubMed 21177789Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC126-0083 in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 3 sites in Denmark.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (adverse events, local tolerability, physical examination) (time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00715689, which also lists 1 linked publication.
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 8 Feb 2017.