OverweightPhase 1NCT07121153
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants When Injected Under the Skin.
A Phase 1 study testing NNC0487-0111 A in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in China.
Trial summary
The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human 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 A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 20 Dec 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 between 24.0 and 34.9 kg/m2 (both inclusive) at screening. Overweight and obesity should be due to excess adipose tissue, as judged by the investigator, with a body weight (more than or equal to) ≥ 65.0 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 condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.
- Any laboratory safety parameters at screening outside the below laboratory ranges:
- Vitamin D (25-hydroxycholecalciferol) less than (<) 12 nanogram per mililiter (ng/mL) [30 nanometer (nM)] at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Total calcium outside normal range at screening
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- Amylase ≥ 2 times upper limit of normal at screening
- Lipase ≥ 2 times upper limit of normal at screening
- Calcitonin ≥ 50 picogram per mililiter (pg/mL) at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Doses of Subcutaneous NNC0487-0111 in Chinese Participants With Overweight or Obesity.
The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0487-0111 A, Placebo A
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111 ADrug
Participants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy.
Placebo ADrug
Participants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | Cohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo. Receives: Drug: NNC0487-0111 A; Drug: Placebo A |
| Cohort A2 | Experimental | Cohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo. Receives: Drug: NNC0487-0111 A; Drug: Placebo A |
| Cohort A3 | Experimental | Cohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo. Receives: Drug: NNC0487-0111 A; Drug: Placebo A |
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 NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23)
Secondary outcomes (6)
AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
h*nmol/L
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose
nmol/L
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose
h
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose
h
Measured: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
Relative change in body weight
Measured: From baseline Day 1 until completion of the end of study visit (Day 23)
Change in fasting plasma glucose
mmol/L
Measured: From baseline Day 1 until completion of the end of study visit (Day 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start11 Aug 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT07121153
- Sponsor's protocol ID
- NN9490-8213
- Other IDs
- U1111-1311-5582
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2025
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Doses of Subcutaneous NNC0487-0111 in Chinese Participants With Overweight or Obesity.
- ClinicalTrials.gov ID
- NCT07121153
- Acronym / sponsor ID
- NN9490-8213
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 13 Aug 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 medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2. The aim of the study is to see how safe the study medicine is and how it behaves in human body. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) and which treatment they get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors but has previously been tested in humans. This study will last for up to 53 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: NNC0487-0111 A, Drug: Placebo ACohort A1 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 1 of active treatment and 3 participants randomised to receive placebo. |
| Cohort A2 | Experimental | Drug: NNC0487-0111 A, Drug: Placebo ACohort A2 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 2 of active treatment and 3 participants randomised to receive placebo. |
| Cohort A3 | Experimental | Drug: NNC0487-0111 A, Drug: Placebo ACohort A3 will include 12 participants randomised (3:1), with 9 participants being randomised to receive a single dose level 3 of active treatment and 3 participants randomised to receive placebo. |
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 between 24.0 and 34.9 kg/m2 (both inclusive) at screening. Overweight and obesity should be due to excess adipose tissue, as judged by the investigator, with a body weight (more than or equal to) ≥ 65.0 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 condition, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- HbA1c ≥ 6.5 percent (%) [48 milimol per mole (mmol/mol)] at screening.
- Any laboratory safety parameters at screening outside the below laboratory ranges:
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 AParticipants will receive single dose (level 1, level 2, level 3) injection of NNC0487-0111 A subcutaneoulsy. | Drug | Cohort A1, Cohort A2, Cohort A3 |
| Placebo AParticipants will receive single dose (level 1, level 2, level 3) injection of placebo A subcutaneoulsy. | Drug | Cohort A1, Cohort A2, Cohort A3 |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23)
Number of events
6 secondary outcomes
AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
tmax,SD; the time of maximum plasma concentration of NNC0487-0111 after a single dose
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
t1/2,SD; the terminal half-life of NNC0487-0111 after a single dose
Time frame: From pre-dose on Day 1 until completion of the end of study visit (Day 23)
Relative change in body weight
Time frame: From baseline Day 1 until completion of the end of study visit (Day 23)
Change in fasting plasma glucose
Time frame: From baseline Day 1 until completion of the end of study visit (Day 23)
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 17 Feb 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
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 A in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site 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 17 Feb 2026. 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 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. 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 NNC0487-0111 administration (Day 1) to completion of the end of study visit (Day 23)). 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 17 Feb 2026.