OverweightPhase 1NCT06820476
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing
A Phase 1 study testing NNC0487-0111 in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in China.
Trial summary
The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (>=) 24 kilogram per square meter (kg/m^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0487-0111
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesChina
- Study dates
- 9 Feb 2025to 14 May 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m^2)(both inclusive), with a body weight greater than or equal to (>=) 65.0 kilogram (kg), at screening.
- Considered 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.
Who cannot join
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening
- 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 Nanograms per millilitre (ng/mL) (30 nanometer[nM]) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
Show all 9Show fewer
- Amylase greater than or equal to (>=) 2 times upper limit of normal at screening
- Lipase greater than or equal to (>=) 2 times upper limit of normal at screening
- Calcitonin greater than or equal to (>=) 50 picograms per milliliter (pg/mL) at screening
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jinan Central Hospital
Ji'Nan, Shandong, 250000
Jinan Central Hospital
Jinan, Shandong, 250000
About this study
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Oral Doses of NNC0487-0111 in Chinese Participants With Overweight or Obesity
The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (>=) 24 kilogram per square meter (kg/m^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will 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 60 days.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0487-0111, Placebo (NNC0487-0111)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111Drug
Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3.
Placebo (NNC0487-0111)Drug
Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 (dose 1) | Experimental | Participants will be randomized to receive a single dose of NNC0487-0111. Receives: Drug: NNC0487-0111 |
| NNC0487-0111 (dose 2) | Experimental | Participants will be randomized to receive a single dose of NNC0487-0111. Receives: Drug: NNC0487-0111 |
| NNC0487-0111 (dose 3) | Experimental | Participants will be randomized to receive a single dose of NNC0487-0111. Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Participants will be randomized to receive matching Placebo to NNC0487-0111. Receives: Drug: Placebo (NNC0487-0111) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Number of events
Measured: From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)
Secondary outcomes (5)
AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
measured in hour*nanomoles per liter (h*nmol/L)
Measured: From pre-dose on Day 10 until Day 11
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
measured in nanomoles per liter(nmol/L)
Measured: From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose
measured in hour (h)
Measured: From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
Change in bodyweight
measured in percentage (%)
Measured: From baseline Day 1 to Day 11
Change in fasting plasma glucose
measured in millimoles per liter (mmol/L)
Measured: From baseline Day 1 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start9 Feb 2025
- Primary completion14 May 2025
- Study completion14 May 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 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
- NCT06820476
- Sponsor's protocol ID
- NN9487-7573
- Other IDs
- U1111-1289-3164
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2025
- Last updated
- 25 Aug 2026
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Oral Doses of NNC0487-0111 in Chinese Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06820476
- Acronym / sponsor ID
- NN9487-7573
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 11 Feb 2025 (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 is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (>=) 24 kilogram per square meter (kg/m^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will 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 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 (dose 1) | Experimental | Drug: NNC0487-0111Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 2) | Experimental | Drug: NNC0487-0111Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 3) | Experimental | Drug: NNC0487-0111Participants will be randomized to receive a single dose of NNC0487-0111. |
| Placebo | Placebo comparator | Drug: Placebo (NNC0487-0111)Participants will be randomized to receive matching Placebo to NNC0487-0111. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m^2)(both inclusive), with a body weight greater than or equal to (>=) 65.0 kilogram (kg), at screening.
- Considered 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.
Key exclusion criteria (9 listed)
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening
- 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 Nanograms per millilitre (ng/mL) (30 nanometer[nM]) at screening
- Parathyroid hormone (PTH) 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 |
|---|---|---|
| NNC0487-0111Participants will be randomized to receive NNC0487-0111 tablet orally at dose levels 1, 2, or 3. | Drug | NNC0487-0111 (dose 1), NNC0487-0111 (dose 2), NNC0487-0111 (dose 3) |
| Placebo (NNC0487-0111)Participants will be randomized to receive a placebo tablet orally matched to NNC0487-0111. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)
Number of events
5 secondary outcomes
AUC0-24h,MD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 24 hours after last multiple dose
Time frame: From pre-dose on Day 10 until Day 11
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
Time frame: From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose
Time frame: From pre-dose on Day 10 to completion of the end-of-study visit (Day 31)
Change in bodyweight
Time frame: From baseline Day 1 to Day 11
Change in fasting plasma glucose
Time frame: From baseline Day 1 to Day 11
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 25 Aug 2026.
- 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
2 sites 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 in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in China.
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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 (TEAEs) (time frame: From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)). 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 25 Aug 2026.