Healthy VolunteersPhase 1NCT04152915
A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens
A Phase 1 study testing Semaglutide in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2019to 25 May 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.
- Body mass index between 25.0 and 34.9 kg/m^2 (both inclusive) and
- Body weight between 65.0 and 130.0 kg (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid (the two latter are not allowed within 24 hours before screening), within 14 days prior to the day of screening.
- Abuse or intake of alcohol, defined as any of the below:
- Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women)
- Positive alcohol test at screening
Show all 9Show fewer
- Abuse or intake of drugs, defined as any of the below:
- Known or suspected drug/chemical substance abuse within 1 year prior to the day of screening
- Positive drug of abuse test at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for the PDS290 Semaglutide Pen-Injector
The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| DV3396 | Experimental | Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation) Receives: Drug: Semaglutide |
| PDS290 | Experimental | Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation) Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
hours*nmol/L
Measured: 0-840 hours after one dose of s.c. semaglutide 1 mg
Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
nmol/L
Measured: 0-840 hours after one dose of s.c. semaglutide 1 mg
Secondary outcomes (6)
AUC0-168h,sema,0.25mg,SS: Area under the semaglutide concentration time curve from time 0 until 168 hours at steady state after the last dose of s.c. semaglutide 0.25 mg administration
hours*nmol/L
Measured: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration
nmol/L
Measured: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
AUC0-∞,sema,1mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
hours*nmol/L
Measured: 0-840 hours after one dose of s.c. semaglutide 1 mg
tmax,sema,1mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
hours
Measured: 0-840 hours after one dose of s.c. semaglutide 1 mg
tmax,sema,0.25mg,SS: Time of maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration
hours
Measured: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
t½,sema,1mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
hours
Measured: 0-840 hours after one dose of s.c. semaglutide 1 mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start25 Nov 2019
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152915
- Sponsor's protocol ID
- NN9535-4588
- Other IDs
- U1111-1235-3506, 2019-002588-92, 2019
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2019
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Demonstrate Bioequivalence Between Semaglutide D Formulations for the DV3396 Pen-Injector and the Formulation for the PDS290 Semaglutide Pen-Injector
- ClinicalTrials.gov ID
- NCT04152915
- Acronym / sponsor ID
- NN9535-4588
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DV3396 | Experimental | Drug: SemaglutideSemaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation) |
| PDS290 | Experimental | Drug: SemaglutideSemaglutide administered with the PDS290 pen-injector (semaglutide reference formulation) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent.
- Body mass index between 25.0 and 34.9 kg/m^2 (both inclusive) and
- Body weight between 65.0 and 130.0 kg (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (9 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
- Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid (the two latter are not allowed within 24 hours before screening), within 14 days prior to the day of screening.
- Abuse or intake of alcohol, defined as any of the below:
- Known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women)
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 |
|---|---|---|
| SemaglutideIncreasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks | Drug | DV3396, PDS290 |
Primary outcome
AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
hours*nmol/L
Cmax,sema,1mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
nmol/L
6 secondary outcomes
AUC0-168h,sema,0.25mg,SS: Area under the semaglutide concentration time curve from time 0 until 168 hours at steady state after the last dose of s.c. semaglutide 0.25 mg administration
Time frame: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
Cmax,sema,0.25mg,SS: Maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration
Time frame: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
AUC0-∞,sema,1mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
tmax,sema,1mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
tmax,sema,0.25mg,SS: Time of maximum observed semaglutide concentration at steady state after the last dose of s.c. semaglutide 0.25 mg administration
Time frame: 0-168 hours after the last dose of s.c. semaglutide 0.25 mg
t½,sema,1mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg
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 10 Nov 2021.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
AUC0-last,sema,1mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 1 mg administration following a 6-week dose escalation period (time frame: 0-840 hours after one dose of s.c. semaglutide 1 mg). The study lists 2 primary outcomes in all. 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 10 Nov 2021.