OverweightPhase 1NCT07587710
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function
A Phase 1 study testing NNC0487-0111 in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in Slovakia.
Trial summary
The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0487-0111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesSlovakia
- Study dates
- 13 May 2026to 1 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex at birth).
- Age 18-80 years (both inclusive) at the time of signing informed consent.
- Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia2 sites
Summit Clinical Research s.r.o.
Bratislava, 83101
Summit Clinical Research s.r.o.
Malacky, 901 22
About this study
Official title: A Study Investigating the Pharmacokinetic Properties, Safety and Tolerability of NNC0487-0111 in Participants With Various Degrees of Hepatic Impairment and Participants With Normal Hepatic Function
The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.
- Conditions
- Overweight, Obesity
- Being tested
- 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
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh.
| Study group | Role | What they receive |
|---|---|---|
| Severe hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. Receives: Drug: NNC0487-0111 |
| Moderate hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. Receives: Drug: NNC0487-0111 |
| Mild hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. Receives: Drug: NNC0487-0111 |
| Normal hepatic impairment | Experimental | Participants will receive single dose of NNC0487-0111 subcutaneously. Receives: Drug: NNC0487-0111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as hours*nanomole per liter (nmol*h/L)
Measured: From pre-dose on Day 1 up to Day 28
Secondary outcomes (6)
Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose
Measured as nanomoles per liter (nmol/L)
Measured: From pre-dose on Day 1 until Day 5
tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Measured as hour
Measured: From pre-dose on Day 1 until Day 5
t½,: Terminal half-life for NNC0487-0111 after a single dose
Measured as hour
Measured: From pre-dose on Day 1 up to Day 28
Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose
Liter
Measured: From pre-dose on Day 1 up to Day 28
CL/F: Apparent clearance of NNC0487-0111 after a single dose
Measured as liter per hour (L/h)
Measured: From pre-dose on Day 1 up to Day 28
Number of treatment emergent adverse events (TEAEs)
Measured as number of events
Measured: From pre-dose on Day 1 up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start13 May 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
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
- NCT07587710
- Sponsor's protocol ID
- NN9490-8156
- Other IDs
- U1111-1320-4875, 2025-521647-20, 2025
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Pharmacokinetic Properties, Safety and Tolerability of NNC0487-0111 in Participants With Various Degrees of Hepatic Impairment and Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07587710
- Acronym / sponsor ID
- NN9490-8156
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 May 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 May 2026 (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 to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe hepatic impairment | Experimental | Drug: NNC0487-0111Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Moderate hepatic impairment | Experimental | Drug: NNC0487-0111Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Mild hepatic impairment | Experimental | Drug: NNC0487-0111Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Normal hepatic impairment | Experimental | Drug: NNC0487-0111Participants will receive single dose of NNC0487-0111 subcutaneously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female (sex at birth).
- Age 18-80 years (both inclusive) at the time of signing informed consent.
- Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
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 |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors in a skinfold in the thigh. | Drug | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic impairment, Severe hepatic impairment |
Primary outcome
AUC0-∞: 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 up to Day 28
Measured as hours*nanomole per liter (nmol*h/L)
6 secondary outcomes
Cmax: Maximum observed plasma NNC0487-0111 concentration after a single dose
Time frame: From pre-dose on Day 1 until Day 5
tmax: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Time frame: From pre-dose on Day 1 until Day 5
t½,: Terminal half-life for NNC0487-0111 after a single dose
Time frame: From pre-dose on Day 1 up to Day 28
Vz/F: Apparent volume of distribution of NNC0487-0111 after a single dose
Time frame: From pre-dose on Day 1 up to Day 28
CL/F: Apparent clearance of NNC0487-0111 after a single dose
Time frame: From pre-dose on Day 1 up to Day 28
Number of treatment emergent adverse events (TEAEs)
Time frame: From pre-dose on Day 1 up to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 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.
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 Slovakia.
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: opening soon, as of the sponsor's last update on 14 May 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 Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞: 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 up to Day 28). 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 14 May 2026.