OverweightPhase 1NCT04187300
A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
A Phase 1 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- 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
- 16 Dec 2019to 23 Sep 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
- No healthy volunteers
- 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 (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
- Body weight between 70.0 and 130.0 kg (both inclusive)
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Inability or unwillingness to perform self-injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity
The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide
- Medical subject headings
- Overweight, Obesity
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 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| DV3396 | Experimental | Semaglutide administered with the DV3396 pen-injector (Formulation D) Receives: Drug: Semaglutide |
| PDS290 | Experimental | Semaglutide administered with the PDS290 pen-injector (Formulation B) Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve
h*nmol/L
Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose
Cmax,2.4mg,SS, Maximum observed semaglutide concentration
nmol/L
Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose
Secondary outcomes (10)
AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve
h*nmol/L
Measured: 0-168 hours (Day 78-85) after last 1 mg dose
Cmax,1mg,SS, Maximum observed semaglutide concentration
nmol/L
Measured: 0-168 hours (Day 78-85) after last 1 mg dose
Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose
h
Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose
Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose
h
Measured: 0-168 hours (Day 78-85) after last 1 mg dose
t½, terminal elimination half-life of semaglutide after last 2.4 mg dose
h
Measured: 0-1176 hours (Day 141-190) after last 2.4 mg dose
Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose
L/h
Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose
Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose
L/h
Measured: 0-168 hours (Day 78-85) after last 1 mg dose
Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose
L
Measured: 0-168 hours (Day 141-148) after last 2.4 mg dose
Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose
L
Measured: 0-168 hours (Day 78-85) after last 1 mg dose
Change in body weight
Measured: From baseline (Day 1, pre-dose) until the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start16 Dec 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- NCT04187300
- Sponsor's protocol ID
- NN9536-4590
- Other IDs
- U1111-1236-7697, 2019-002909-21, 2019
- Status last verified
- Nov 2021
- First submitted
- 3 Dec 2019
- Last updated
- 11 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04187300
- Acronym / sponsor ID
- NN9536-4590
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 5 Dec 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 forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are 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 (Formulation D) |
| PDS290 | Experimental | Drug: SemaglutideSemaglutide administered with the PDS290 pen-injector (Formulation B) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
- Body weight between 70.0 and 130.0 kg (both inclusive)
Key exclusion criteria (3 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Inability or unwillingness to perform self-injection
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 20 weeks | Drug | DV3396, PDS290 |
Primary outcome
AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
h*nmol/L
Cmax,2.4mg,SS, Maximum observed semaglutide concentration
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
nmol/L
10 secondary outcomes
AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Cmax,1mg,SS, Maximum observed semaglutide concentration
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
t½, terminal elimination half-life of semaglutide after last 2.4 mg dose
Time frame: 0-1176 hours (Day 141-190) after last 2.4 mg dose
Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose
Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose
Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose
Time frame: 0-168 hours (Day 78-85) after last 1 mg dose
Change in body weight
Time frame: From baseline (Day 1, pre-dose) until the end of treatment
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 11 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 Overweight and Obesity, 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 3 inclusion and 3 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 11 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?
AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve (time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose). 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 11 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.