ObesityPhase 1NCT06049329
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
A Phase 1 study testing NNC0487-0111 in people with Obesity, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- 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
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 14 Sep 2023to 15 Dec 2023
- 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
- Male with both parents of Japanese descent
- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Body weight equal to or greater than 65.0 kg
- 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 that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.
- Conditions
- Obesity
- Being tested
- NNC0487-0111, Placebo (NNC0487-0111)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111Drug
Participants will get one tablet to swallow at the same time of the day.
Placebo (NNC0487-0111)Drug
Participants will get one tablet to swallow at the same time of the day.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Once-daily oral administration - 1 of 3 different doses Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Once-daily oral administration - 1 of 3 different doses 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 (TEAE)
Number of events
Measured: From pre-dose on Day 1 until completion of the end of study visit Day 31
Secondary outcomes (3)
AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose
h*nmol/L
Measured: From pre-dose on Day 10 until Day 11 (24 hours post-dose)
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
nmol/L
Measured: From pre-dose on Day 10 until completion of the end of study visit Day 31
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose
hour
Measured: From pre-dose on Day 10 until completion of the end of study visit Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start14 Sep 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT06049329
- Sponsor's protocol ID
- NN9487-5022
- Other IDs
- U1111-1284-5901
- Status last verified
- Mar 2025
- First submitted
- 11 Sep 2023
- Last updated
- 5 Mar 2025
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
- ClinicalTrials.gov ID
- NCT06049329
- Acronym / sponsor ID
- NN9487-5022
- Conditions
- 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
- 14 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 22 Sep 2023 (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 purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111Once-daily oral administration - 1 of 3 different doses |
| Placebo | Placebo comparator | Drug: Placebo (NNC0487-0111)Once-daily oral administration - 1 of 3 different doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male with both parents of Japanese descent
- Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Body weight equal to or greater than 65.0 kg
- 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 (2 listed)
- Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator
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 get one tablet to swallow at the same time of the day. | Drug | NNC0487-0111 |
| Placebo (NNC0487-0111)Participants will get one tablet to swallow at the same time of the day. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAE)
Time frame: From pre-dose on Day 1 until completion of the end of study visit Day 31
Number of events
3 secondary outcomes
AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose
Time frame: From pre-dose on Day 10 until Day 11 (24 hours post-dose)
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
Time frame: From pre-dose on Day 10 until 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 until completion of the end of study visit Day 31
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 5 Mar 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 in people with Obesity, run by Novo Nordisk A/S at 1 site in Japan.
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 3 inclusion and 2 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 5 Mar 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 Japan. 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) (time frame: From pre-dose on Day 1 until 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 5 Mar 2025.