Diabetes Mellitus, Type 2Phase 1NCT05046873
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
A Phase 1 study testing Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL, Semaglutide 1.34 mg/mL and NNC0480-0389 A 10 mg/mL in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
In this study, participants will receive semaglutide and NNC0480-0389 together at the same time. Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new potential medicine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL, Semaglutide 1.34 mg/mL and NNC0480-0389 A 10 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 6 Sep 2021to 5 Jan 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female of non-childbearing potential (NCBP), aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive).
Who cannot join
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycosylated haemoglobin (HbA1c) more than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days before screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Pharmacokinetics of Semaglutide and NNC0480-0389 When Subcutaneously Administered as a Co-formulation or as Separate Injections in Healthy Participants
In this study, participants will receive semaglutide and NNC0480-0389 together at the same time. Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new potential medicine. Giving the medicines at the same time will be investigated once by using two separate syringes and once by using only one syringe containing both medicines ("co-formulation"). The co-formulation will be given together with an injection of placebo. Both medicines are tested for the treatment of type 2 diabetes. Giving the two complementary medicines at the same time is intended to lower blood sugar in people with type 2 diabetes. NNC0480-0389, in combination with semaglutide, is already being investigated in an ongoing human clinical study.
The aim of this study is to compare the amount of medicine (semaglutide and NNC0480-0389) in the blood: after participants received the medicines at the same time (0.5 mg semaglutide and 5 mg NNC0480-0389) using only one syringe (co-formulation)after participants received the medicines separately using two syringes.
Read more
For this purpose, the amount of semaglutide and NNC0480-0389 in the blood will be measured after participants received the medicines in co-formulation and after participants received the medicines using separate syringes. There will be two treatment periods: One period where participants receive the two medicines as two separate injections and another period where participants receive the two medicines in one injection (co-formulation), together with an injection of placebo. It will be randomly determined in which order participants will receive the 2 treatments (separate injections first or co-formulation first).
For both treatments the study medicines will be injected into a skin fold in the left and right stomach using a thin needle.Giving the medicines in the two treatment periods will take place at an interval of at least 8 weeks. The study can last for up to 19 weeks for each participant. This includes a screening period (up to 4 weeks), two treatment periods (5 weeks each) and a washout period (3 - 5 weeks). The washout period ensures that the given treatments and their effects have disappeared from the body. Participants will not receive any study medicines during this time. Participants will have 21 clinic visits. Some of the visits include overnight stays. Participants will have blood tests at every clinic visit.
For 4 visits (Visits 2, 11, 12 and 21; Day 1 and 36 of each period) participants must not have had any food or drink (water is allowed) for up to 8 hours before participantsr body weight is measured. Participants must be healthy and have a body mass index (BMI) between 20.0 and 29.9 kg/m2. If participants are a woman participants can only take part in this clinical study, if participants cannot get pregnant, for example, after menopause. A hormone test will be done to confirm this.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL, semaglutide 1.34 mg/mL (placebo), Semaglutide 1.34 mg/mL, NNC0480-0389 A 10 mg/mL
- 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.
Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mLDrug
Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.
semaglutide 1.34 mg/mL (placebo)Drug
Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks.
Semaglutide 1.34 mg/mLDrug
The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
NNC0480-0389 A 10 mg/mLDrug
The participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NNC0480-0389 + semaglutide(co-formulation)and placebo | Experimental | Sequence A: The participants will be administered a single subcutanous (s.c.) dose of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as a co-formulation by a single injection and a placebo injection Receives: Drug: Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL; Drug: semaglutide 1.34 mg/mL (placebo) |
| NNC0480-0389 + semaglutide (separate injections) | Active comparator | Sequence B: The participants will be administered 0.5 mg semaglutide and 5 mg NNC0480 0389 as an subcutaneus injection (s.c) on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as two separate injections. Receives: Drug: Semaglutide 1.34 mg/mL; Drug: NNC0480-0389 A 10 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose
h*nmol/L
Measured: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve after a single dose
h*nmol/L
Measured: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
Secondary outcomes (2)
Cmax,sema,SD: Maximum plasma concentration of semaglutide after a single dose
nmol/L
Measured: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 after a single dose
nmol/L
Measured: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start6 Sep 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046873
- Sponsor's protocol ID
- NN9389-4679
- Other IDs
- U1111-1266-0502, 2021-001397-36
- Status last verified
- Jun 2023
- First submitted
- 8 Sep 2021
- Last updated
- 3 Jul 2023
- 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Pharmacokinetics of Semaglutide and NNC0480-0389 When Subcutaneously Administered as a Co-formulation or as Separate Injections in Healthy Participants
- ClinicalTrials.gov ID
- NCT05046873
- Acronym / sponsor ID
- NN9389-4679
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 16 Sep 2021 (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.
In this study, participants will receive semaglutide and NNC0480-0389 together at the same time. Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new potential medicine. Giving the medicines at the same time will be investigated once by using two separate syringes and once by using only one syringe containing both medicines ("co-formulation"). The co-formulation will be given together with an injection of placebo. Both medicines are tested for the treatment of type 2 diabetes. Giving the two complementary medicines at the same time is intended to lower blood sugar in people with type 2 diabetes. NNC0480-0389, in combination with semaglutide, is already being investigated in an ongoing human clinical study.
The aim of this study is to compare the amount of medicine (semaglutide and NNC0480-0389) in the blood: after participants received the medicines at the same time (0.5 mg semaglutide and 5 mg NNC0480-0389) using only one syringe (co-formulation)after participants received the medicines separately using two syringes.
For this purpose, the amount of semaglutide and NNC0480-0389 in the blood will be measured after participants received the medicines in co-formulation and after participants received the medicines using separate syringes. There will be two treatment periods: One period where participants receive the two medicines as two separate injections and another period where participants receive the two medicines in one injection (co-formulation), together with an injection of placebo. It will be randomly determined in which order participants will receive the 2 treatments (separate injections first or co-formulation first).
For both treatments the study medicines will be injected into a skin fold in the left and right stomach using a thin needle.Giving the medicines in the two treatment periods will take place at an interval of at least 8 weeks. The study can last for up to 19 weeks for each participant. This includes a screening period (up to 4 weeks), two treatment periods (5 weeks each) and a washout period (3 - 5 weeks). The washout period ensures that the given treatments and their effects have disappeared from the body. Participants will not receive any study medicines during this time. Participants will have 21 clinic visits. Some of the visits include overnight stays. Participants will have blood tests at every clinic visit.
For 4 visits (Visits 2, 11, 12 and 21; Day 1 and 36 of each period) participants must not have had any food or drink (water is allowed) for up to 8 hours before participantsr body weight is measured. Participants must be healthy and have a body mass index (BMI) between 20.0 and 29.9 kg/m2. If participants are a woman participants can only take part in this clinical study, if participants cannot get pregnant, for example, after menopause. A hormone test will be done to confirm this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0480-0389 + semaglutide(co-formulation)and placebo | Experimental | Drug: Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL, Drug: semaglutide 1.34 mg/mL (placebo)Sequence A: The participants will be administered a single subcutanous (s.c.) dose of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as a co-formulation by a single injection and a placebo injection |
| NNC0480-0389 + semaglutide (separate injections) | Active comparator | Drug: Semaglutide 1.34 mg/mL, Drug: NNC0480-0389 A 10 mg/mLSequence B: The participants will be administered 0.5 mg semaglutide and 5 mg NNC0480 0389 as an subcutaneus injection (s.c) on two separate dosing visits separated by at least 8 weeks. The two drugs will be administered as two separate injections. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female of non-childbearing potential (NCBP), aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive).
Key exclusion criteria (4 listed)
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycosylated haemoglobin (HbA1c) more than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days before screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
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 |
|---|---|---|
| Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mLParticipants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks. | Drug | NNC0480-0389 + semaglutide(co-formulation)and placebo |
| semaglutide 1.34 mg/mL (placebo)Participants will receive a subcutaneus (s.c) co-formulation injection of 0.5 mg semaglutide and 5 mg NNC0480-0389 together with a subcutaneus injection (s.c) of semaglutide(placebo)on two separate dosing visits separated by at least 8 weeks. | Drug | NNC0480-0389 + semaglutide(co-formulation)and placebo |
| Semaglutide 1.34 mg/mLThe participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks. | Drug | NNC0480-0389 + semaglutide (separate injections) |
| NNC0480-0389 A 10 mg/mLThe participants will be receive a subcutaneus (s.c) injection of 0.5 mg semaglutide and 5 mg NNC0480 0389 on two separate doing visits separated by at least 8 weeks. | Drug | NNC0480-0389 + semaglutide (separate injections) |
Primary outcome
AUC0-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose
Time frame: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
h*nmol/L
AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve after a single dose
Time frame: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
h*nmol/L
2 secondary outcomes
Cmax,sema,SD: Maximum plasma concentration of semaglutide after a single dose
Time frame: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 after a single dose
Time frame: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)
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 3 Jul 2023.
- 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 Transparency (dept. 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 Co-formulation NNC0480 0389+Semaglutide A 10/1 mg/mL, Semaglutide 1.34 mg/mL and NNC0480-0389 A 10 mg/mL in people with 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 2 inclusion and 4 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 3 Jul 2023. 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-∞,sema,SD: Area under the semaglutide plasma concentration-time curve after a single dose (time frame: From baseline (visit 2/12, day 1, pre-dose) until completion of the assessment period (visit 11/21, day 36)). 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 3 Jul 2023.