ObesityPhase 1NCT06478563
A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity
A Phase 1 study testing NNC0487-0111 (formulation D) and NNC0487-0111 (formulation C) in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- NNC0487-0111 (formulation D) and NNC0487-0111 (formulation C)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 1 Jul 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- Age 18-64 years (both inclusive)
- Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2) (both inclusive)
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Who cannot join
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
- Vitamin D (25-hydroxycholecalciferol) less than (<) 12 ng/mL (30 Nanometer (nM)) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
- Calcitonin greater than or equal to (≥) 50 pg/mL at screening
Show all 9Show fewer
- Amylase greater than or equal to (≥) 2 times upper limit of normal
- Lipase greater than or equal to (≥) 2 times upper limit of normal
- Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
- Conditions
- Obesity, Overweight
- Being tested
- NNC0487-0111 (formulation D), NNC0487-0111 (formulation C)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111 (formulation D)Drug
Participants will receive NNC0487-0111 (formulation D) tablet once daily.
NNC0487-0111 (formulation C)Drug
Participants will receive NNC0487-0111 (formulation C) tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Phase A: NNC0487-0111 (formulation D) | Experimental | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). Receives: Drug: NNC0487-0111 (formulation D) |
| Phase A: NNC0487-0111 (formulation C) | Active comparator | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). Receives: Drug: NNC0487-0111 (formulation C) |
| Phase B: NNC0487-0111 (formulation D) | Experimental | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). Receives: Drug: NNC0487-0111 (formulation D) |
| Phase B: NNC0487-0111 (formulation C) | Active comparator | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). Receives: Drug: NNC0487-0111 (formulation C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state
Measured as hours*nanomoles per liter (h*nmol/L)
Measured: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Secondary outcomes (7)
Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state
Measured as nanomoles per liter (nmol/L)
Measured: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state
Measured as hours
Measured: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Phase B: The area under the NNC0487-0111 plasma concentration-time curve
Measured as h*nmol/L
Measured: From pre-dose to after dosing on day 132
Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose
Measured as nmol/L
Measured: From pre-dose to after dosing on day 132
Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose
Measured as hours
Measured: From pre-dose to after dosing on day 132
Phase B:The terminal half-life of NNC0487-0111 after the last dose
Measured as hours
Measured: From pre-dose on day 132 until completion of the end of study visit (day 153)
Number of treatment emergent adverse events (TEAE)
Measured as number of events
Measured: From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start27 Jun 2024
- Primary completion5 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478563
- Sponsor's protocol ID
- NN9487-7980
- Other IDs
- U1111-1300-3720
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06478563
- Acronym / sponsor ID
- NN9487-7980
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 27 Jun 2024 (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.
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase A: NNC0487-0111 (formulation D) | Experimental | Drug: NNC0487-0111 (formulation D)Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase A: NNC0487-0111 (formulation C) | Active comparator | Drug: NNC0487-0111 (formulation C)Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase B: NNC0487-0111 (formulation D) | Experimental | Drug: NNC0487-0111 (formulation D)Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). |
| Phase B: NNC0487-0111 (formulation C) | Active comparator | Drug: NNC0487-0111 (formulation C)Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female
- Age 18-64 years (both inclusive)
- Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2) (both inclusive)
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Key exclusion criteria (9 listed)
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
- Vitamin D (25-hydroxycholecalciferol) less than (<) 12 ng/mL (30 Nanometer (nM)) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
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 |
|---|---|---|
| NNC0487-0111 (formulation D)Participants will receive NNC0487-0111 (formulation D) tablet once daily. | Drug | Phase A: NNC0487-0111 (formulation D), Phase B: NNC0487-0111 (formulation D) |
| NNC0487-0111 (formulation C)Participants will receive NNC0487-0111 (formulation C) tablet once daily. | Drug | Phase A: NNC0487-0111 (formulation C), Phase B: NNC0487-0111 (formulation C) |
Primary outcome
Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state
Time frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Measured as hours*nanomoles per liter (h*nmol/L)
7 secondary outcomes
Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state
Time frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state
Time frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Phase B: The area under the NNC0487-0111 plasma concentration-time curve
Time frame: From pre-dose to after dosing on day 132
Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose
Time frame: From pre-dose to after dosing on day 132
Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose
Time frame: From pre-dose to after dosing on day 132
Phase B:The terminal half-life of NNC0487-0111 after the last dose
Time frame: From pre-dose on day 132 until completion of the end of study visit (day 153)
Number of treatment emergent adverse events (TEAE)
Time frame: From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)
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 Aug 2025.
- 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. 2834) 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 NNC0487-0111 (formulation D) and NNC0487-0111 (formulation C) in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in United States.
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 11 Aug 2025. 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 United States. 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?
Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state (time frame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126). 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 Aug 2025.