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Healthy VolunteersPhase 1NCT04259801

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes

A Phase 1 study testing NNC0480-0389 and Semaglutide in people with Healthy Volunteers and Overweight, run by Novo Nordisk A/S at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate how safe, and how well tolerated, the new study drug NNC0480-0389 is when it is given together with semaglutide. This will be investigated in healthy participants, participants with high bodyweight and participants with type 2 diabetes (T2D). Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Overweight, Obesity
What is being tested?
NNC0480-0389 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
1 siteNetherlands
Study dates
17 Feb 2020to 16 Mar 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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Part 1:
  • Male aged 18-45 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 20.0 kg/m^2 and 29.9 kg/m^2 (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.
  • Part 2 (not applicable for proof-of-concept (PoC) cohort):
  • Body mass index between 20.0 kg/m^2 and 39.9 kg/m^2 (both inclusive).
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  • Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Considered to be eligible 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.
  • Part 2 (only applicable for PoC cohort):
  • Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive). Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.
  • Female of non-childbearing potential or male aged 18-64 years (both inclusive) at the time of signing informed consent.
  • Considered to be eligible 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.
  • Diagnosed with type 2 diabetes at least 90 days prior to the day of screening.
  • Subjects treated with diet and exercise as monotherapy or in combination with 1-2 of the following anti-diabetic drug(s) at a stable dose for at least 30 days prior to screening: metformin, sulfonylureas, meglitinides, DPP-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, GLP-1 receptor agonists or SLGT-2 inhibitors. The metformin dose should be between 1500 mg to 3000 mg or maximum tolerated or effective dose documented in subject's medical record.
  • Glycosylated haemoglobin (HbA1c) in the range of 6.5% (inclusive) and 10% (non-inclusive).

Who cannot join

  • Part 1:
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
  • HbA1c equal to or above 6.5 % (48 mmol/mol) at screening.
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening. Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
  • Part 2 (not applicable for PoC cohort):
  • Any disorder (except for conditions associated with T2D for the PoC cohort) which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
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  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D for PoC Cohort).
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
  • HbA1c equal to or above 6.5 % (48 mmol/mol) at screening.
  • Part 2 (only applicable for PoC cohort):
  • Any disorder (except for conditions associated with T2D for the PoC cohort) which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with T2D for PoC Cohort).
  • Use of any prohibited medications as listed in the protocol within 14 days of screening.
  • Use of prescribed medications at the time of screening at a dose that had not been stable within 30 days prior to screening.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Novo Nordisk Investigational Site

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of NNC0480-0389 in Combination With Semaglutide s.c.

The purpose of this study is to investigate how safe, and how well tolerated, the new study drug NNC0480-0389 is when it is given together with semaglutide. This will be investigated in healthy participants, participants with high bodyweight and participants with type 2 diabetes (T2D). NNC0480-0389 has not been given to humans before. It has been previously tested in the laboratory and on animals. NNC0480-0389 will be tested at various dose levels. Semaglutide is a new approved drug and is already available on the market for treatment of diabetes. It will also be investigated how quickly and to what extent NNC0480-0389 and semaglutide are taken up and eliminated from the body. This is called pharmacokinetics. The effect of NNC0480-0389 given together with semaglutide will also be investigated on body weight and glucose levels in the blood. This is called pharmacodynamics. The effects of NNC0480-0389 and/or semaglutide will be compared to the effects of a placebo. A placebo is a "dummy" medicine without any active medicine. Placebo looks like NNC0480-0389 and/or semaglutide. There are 4 possibilities for which treatment participants will get; participants will receive NNC0480-0389 and semaglutide or NNC0480-0389 and placebo or placebo with semaglutide, or placebo with placebo. Participants and the responsible doctor will not know which combination participants will be given. This is called a double-blinded study. However, this information can be looked up during the study if it is important for participants' health. The study medicines will be given as injections under the skin. Participants will be in the study for about 25 weeks.

Being tested
NNC0480-0389, Semaglutide, Placebo (NNC0480-0389), Placebo (semaglutide)
Medical subject headings
Overweight, Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0480-0389Drug

    Part 1: A single dose of NNC0480-0389, dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of NNC0480-0389, dose increased in each cohort.

  • SemaglutideDrug

    Part 1: Single dose of semaglutide (0.5 mg). Part 2: Weekly doses of semaglutide alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.

  • Placebo (NNC0480-0389)Drug

    Placebo for NNC0480-0389. Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort.

  • Placebo (semaglutide)Drug

    Part 1: Single dose of placebo (semaglutide) (0.5 mg). Part 2: Weekly doses of placebo (semaglutide) alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.

Study groups in NCT04259801
Study groupRoleWhat they receive
NNC0480-0389 and semaglutideExperimentalPart 1: 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide. Part 2: 12 subjects will receive 4 doses of s.c. NNC0480-0389 co-administered with s.c. semaglutide, after 8 weeks of dosing with s.c semaglutide.
Receives: Drug: NNC0480-0389; Drug: Semaglutide
NNC0480-0389 and placebo (semaglutide)ExperimentalPart 1: 4 subjects will receive a single dose of s.c. NNC0480-0389 co-administered with semaglutide placebo. Part 2: 4 subjects will receive 4 doses of s.c. NNC0480-0389, co-administered with semaglutide placebo after 8 weeks of dosing with semaglutide placebo.
Receives: Drug: NNC0480-0389; Drug: Placebo (NNC0480-0389)
Placebo (NNC0480-0389) with semaglutideActive comparatorPart 1: 2 subjects will receive a single dose of placebo (NNC0480-0389), co-administered with s.c. semaglutide. Part 2: 4 subjects will receive 4 doses of placebo (NNC0480-0389), co-administered with s.c. semaglutide, after 8 weeks of dosing with s.c. semaglutide
Receives: Drug: Semaglutide; Drug: Placebo (semaglutide)
Placebo (NNC0480-0389) with placebo (semaglutide)Placebo comparatorPart 1: 3 subjects will receive a single dose of placebo (NNC0480-0389), co-administered with semaglutide placebo. Part 2: 2 subjects will receive 4 doses of placebo (NNC0480-0389), co-administered with semaglutide placebo, after 8 weeks of dosing with semaglutide placebo.
Receives: Drug: Placebo (NNC0480-0389); Drug: Placebo (semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events (TEAE) in Part 1

    Number of events

    Measured: From time of dosing (day 1) until completion of follow-up visit (day 71)

  2. Number of treatment emergent adverse events (TEAE) in Part 2

    Number of events

    Measured: From first combination dosing (day 57) until completion of follow-up visit (day 148)

Secondary outcomes (8)

  1. Area under the NNC0480-0389 plasma concentration-time curve from time

    h∙nmol/L

    Measured: From baseline (day 1) to post treatment follow-up (day 71)

  2. Maximum plasma concentration of NNC0480-0389 after administration of a single dose

    nmol/L

    Measured: From baseline (day 1) to post treatment follow-up (day 71)

  3. Area under the semaglutide plasma concentration time curve from time of dosing to infinity after administration of a single dose

    h∙nmol/L

    Measured: From baseline (day 1) to post treatment follow-up (day 71)

  4. The maximum concentration of semaglutide after administration of a single dose

    nmol/L

    Measured: From baseline (day 1) to post treatment follow-up (day 71)

  5. Area under the NNC0480-0389 plasma concentration-time curve from 0 to 168 hours after administration of the 4th dose of NNC0480-0389 in week 12

    h∙nmol/L

    Measured: From administration of dose in week 12 (day 78) to day 85

  6. Maximum plasma concentration of NNC0480-0389 after administration of the 4th dose of NNC0480-0389 in week 12

    nmol/L

    Measured: From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)

  7. Area under the semaglutide plasma concentration-time curve from 0-168 hours after administration of the 12th dose of semaglutide

    h∙nmol/L

    Measured: From administration of dose in week 12 (day 78) to day 85

  8. The maximum concentration of semaglutide after administration of the 12th dose of semaglutide

    nmol/L

    Measured: From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start17 Feb 2020
  3. Primary completion16 Mar 2022
  4. Study completion16 Mar 2022

Resources

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
Model description
Part 1: Single ascending dose Part 2: Multiple ascending dose
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259801
Sponsor's protocol ID
NN9389-4536
Other IDs
2019-002857-44, U1111-1236-4114, 2019
Status last verified
Nov 2023
First submitted
5 Feb 2020
Last updated
13 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0480-0389 and Semaglutide in people with Healthy Volunteers and Overweight, run by Novo Nordisk A/S at 1 site in Netherlands.

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 15 inclusion and 14 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 13 Nov 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?

Number of treatment emergent adverse events (TEAE) in Part 1 (time frame: From time of dosing (day 1) until completion of follow-up visit (day 71)). 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?

On the ClinicalTrials.gov record for NCT04259801.

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 13 Nov 2023.

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