OverweightPhase 1NCT04238962
A Research Study to Compare Two Different Forms of Once-weekly Semaglutide in Two Different Injection Pens
A Phase 1 study testing Semaglutide (administered by DV3396 pen-injector) and Semaglutide (administered by PDS290 pen-injector) 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 2 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 is decided by chance. 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 (administered by DV3396 pen-injector) and Semaglutide (administered by PDS290 pen-injector)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- 3 Feb 2020to 20 Oct 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 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- 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 or herbal products, except routine vitamins, topical medication, 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 -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits)
- 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 the Semaglutide D Formulation for the DV3396 Pen-Injector and the Formulation for the PDS290 Pen-Injector Following Subcutaneous Administration of 2 mg Semaglutide
The study will look at how 2 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 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 medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit 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. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide (administered by DV3396 pen-injector), Semaglutide (administered by PDS290 pen-injector)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (administered by DV3396 pen-injector)Drug
Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks
Semaglutide (administered by PDS290 pen-injector)Drug
Increasing doses of semaglutide given sc in the stomach for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| DV3396 | Experimental | Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product) Receives: Drug: Semaglutide (administered by DV3396 pen-injector) |
| PDS290 | Active comparator | Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product) Receives: Drug: Semaglutide (administered by PDS290 pen-injector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
h*nmol/L
Measured: 0-840 hours after one dose of s.c. semaglutide 2 mg
Cmax,sema,2mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
nmol/L
Measured: 0-840 hours after one dose of s.c. semaglutide 2 mg
Secondary outcomes (3)
AUC0-∞,sema,2mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
h*nmol/L
Measured: 0-840 hours after one dose of s.c. semaglutide 2 mg
tmax,sema,2mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
h
Measured: 0-840 hours after one dose of s.c. semaglutide 2 mg
t½,sema,2mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
h
Measured: 0-840 hours after one dose of s.c. semaglutide 2 mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start3 Feb 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 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
- 111 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
- NCT04238962
- Sponsor's protocol ID
- NN9535-4601
- Other IDs
- U1111-1239-1473, 2019-003477-25, 2019
- Status last verified
- Nov 2020
- First submitted
- 22 Jan 2020
- Last updated
- 20 Nov 2020
- 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 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Demonstrate Bioequivalence Between the Semaglutide D Formulation for the DV3396 Pen-Injector and the Formulation for the PDS290 Pen-Injector Following Subcutaneous Administration of 2 mg Semaglutide
- ClinicalTrials.gov ID
- NCT04238962
- Acronym / sponsor ID
- NN9535-4601
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 23 Jan 2020 (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 2 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 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 medicine as an injection under the skin of the belly with a pen-injector. The type of pen-injector is different for the 2 versions of semaglutide. Participants will receive 7 once-weekly injections in total. The study will last for about 80-106 days. Participants will have 19 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic, 1 visit for 2 days and 1 night and the other visit 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. Participants cannot take part in this study if they have any disease or disorder that the study doctor thinks is a health problem. 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: Semaglutide (administered by DV3396 pen-injector)Participants will receive once-weekly doses of semaglutide administered with the DV3396 pen-injector (test drug product) |
| PDS290 | Active comparator | Drug: Semaglutide (administered by PDS290 pen-injector)Participants will receive once-weekly doses of semaglutide administered with the PDS290 pen-injector (comparator drug product) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not 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 (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- 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 or herbal products, except routine vitamins, topical medication, 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 -12 g of alcohol equals about 300 mL of beer or lager, 100 mL of wine, or 25 mL spirits)
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 |
|---|---|---|
| Semaglutide (administered by DV3396 pen-injector)Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks | Drug | DV3396 |
| Semaglutide (administered by PDS290 pen-injector)Increasing doses of semaglutide given sc in the stomach for 7 weeks | Drug | PDS290 |
Primary outcome
AUC0-last,sema,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
h*nmol/L
Cmax,sema,2mg: Maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
nmol/L
3 secondary outcomes
AUC0-∞,sema,2mg: Area under the semaglutide concentration time curve from time 0 until infinity after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
tmax,sema,2mg: Time of maximum observed semaglutide concentration after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 mg
t½,sema,2mg: terminal elimination half-life of semaglutide after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period
Time frame: 0-840 hours after one dose of s.c. semaglutide 2 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 20 Nov 2020.
- 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 (administered by DV3396 pen-injector) and Semaglutide (administered by PDS290 pen-injector) 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 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 20 Nov 2020. 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,2mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after one dose of s.c. semaglutide 2 mg administration following a 6-week dose escalation period (time frame: 0-840 hours after one dose of s.c. semaglutide 2 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 20 Nov 2020; AzTrials last refreshed its copy on 30 Oct 2026.