Growth Hormone DisorderPhase 1NCT01706783
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
A Phase 1 study testing somapacitan and Norditropin NordiFlex® in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 4 sites in 2 countries.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- somapacitan and Norditropin NordiFlex®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Oct 2012to 18 Nov 2013
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
- Stable human growth hormone (hGH) replacement therapy for at least 3 months
Who cannot join
- Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
- Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
- Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- Heart insufficiency, New York Heart Association (NYHA) class above 2
- Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
- Stable pituitary replacement therapy for less than 3 months
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
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: A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).
- Being tested
- somapacitan, Norditropin NordiFlex®
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somapacitanDrug
Also called NNC0195-0092
Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order
Norditropin NordiFlex®Drug
Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency
| Study group | Role | What they receive |
|---|---|---|
| NNC0195-0092 (somapacitan) | Experimental | Not described Receives: Drug: somapacitan |
| Norditropin NordiFlex® | Active comparator | Not described Receives: Drug: Norditropin NordiFlex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: From first administration of trial product and up until Day 49
Secondary outcomes (10)
NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)
Measured: From 0 to 168 hours
Norditropin NordiFlex® only: AUC (0-24h)
Measured: From 0 to 24 hours
NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)
Measured: From 0 to 168 hours
Norditropin NordiFlex®, first dose administration only: AUC (0-24h)
Measured: From 0 to 24 hours
NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)
Measured: From 0 to 168 hours
Norditropin NordiFlex®: Cmax
Measured: From 0 to 24 hours
Insulin-like growth factor I (IGF-I): AUC (0-168h)
Measured: From 0 to 168 hours
IGF-I: Cmax
Measured: From 0 to 168 hours
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)
Measured: From 0 to 168 hours
IGFBP-3: Cmax
Measured: From 0 to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study start12 Oct 2012
- Primary completion18 Nov 2013
- Study completion18 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT01706783
- Sponsor's protocol ID
- NN8640-3947
- Other IDs
- 2011-005484-24, U1111-1125-7331
- Status last verified
- Dec 2020
- First submitted
- 11 Oct 2012
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
PubMed 33313798Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
PubMed 33864240Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
PubMed 29671202Rasmussen MH, Janukonyte J, Klose M, Marina D, Tanvig M, Nielsen LF, Hoybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS. Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency. J Clin Endocrinol Metab. 2016 Mar;101(3):988-98. doi: 10.1210/jc.2015-1991. Epub 2016 Jan 4.
PubMed 26727076
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT01706783
- Acronym / sponsor ID
- NN8640-3947
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2012 (actual)
- Primary completion
- 18 Nov 2013 (actual)
- Study completion
- 18 Nov 2013 (actual)
- First posted
- 15 Oct 2012 (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 the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0195-0092 (somapacitan) | Experimental | Drug: somapacitan |
| Norditropin NordiFlex® | Active comparator | Drug: Norditropin NordiFlex® |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
- Stable human growth hormone (hGH) replacement therapy for at least 3 months
Key exclusion criteria (6 listed)
- Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
- Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
- Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
- Heart insufficiency, New York Heart Association (NYHA) class above 2
- Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
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 |
|---|---|---|
| somapacitanAlso: NNC0195-0092Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order | Drug | NNC0195-0092 (somapacitan) |
| Norditropin NordiFlex®Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency | Drug | Norditropin NordiFlex® |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From first administration of trial product and up until Day 49
10 secondary outcomes
NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)
Time frame: From 0 to 168 hours
Norditropin NordiFlex® only: AUC (0-24h)
Time frame: From 0 to 24 hours
NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)
Time frame: From 0 to 168 hours
Norditropin NordiFlex®, first dose administration only: AUC (0-24h)
Time frame: From 0 to 24 hours
NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)
Time frame: From 0 to 168 hours
Norditropin NordiFlex®: Cmax
Time frame: From 0 to 24 hours
Insulin-like growth factor I (IGF-I): AUC (0-168h)
Time frame: From 0 to 168 hours
IGF-I: Cmax
Time frame: From 0 to 168 hours
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)
Time frame: From 0 to 168 hours
IGFBP-3: Cmax
Time frame: From 0 to 168 hours
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 24 Dec 2020.
- Background: PubMed 33313798Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.
- Derived from this study: PubMed 33864240Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.
- Derived from this study: PubMed 29671202Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.
- Derived from this study: PubMed 26727076Rasmussen MH, Janukonyte J, Klose M, Marina D, Tanvig M, Nielsen LF, Hoybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS. Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency. J Clin Endocrinol Metab. 2016 Mar;101(3):988-98. doi: 10.1210/jc.2015-1991. Epub 2016 Jan 4.
- 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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing somapacitan and Norditropin NordiFlex® in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 4 sites in 2 countries.
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 2 inclusion and 6 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of adverse events (AEs) (time frame: From first administration of trial product and up until Day 49). 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 NCT01706783, which also lists 4 linked publications.
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 24 Dec 2020.