ObesityPhase 1NCT07566390
A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity
A Phase 1 study testing NNC0113-5840 in people with Obesity and Overweight, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- NNC0113-5840
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2026to 31 Jan 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- 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 and visit 2, day -1, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) [48 millimole per mole (mmol/mol)] at screening.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, 21225
- Recruiting
PAREXEL Glendale/LA EPCU
Glendale, California, 91206
About this study
Official title: A First in Human Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC0113-5840 in Participants With Overweight or Obesity
The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.
- Conditions
- Obesity, Overweight
- Being tested
- NNC0113-5840, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0113-5840Drug
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
PlaceboDrug
Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously. Receives: Drug: NNC0113-5840 |
| Cohort 2 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously. Receives: Drug: NNC0113-5840 |
| Cohort 3 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously. Receives: Drug: NNC0113-5840 |
| Cohort 4 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously. Receives: Drug: NNC0113-5840 |
| Cohort 5 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously. Receives: Drug: NNC0113-5840 |
| Cohort 6 NNC0113-5840 | Experimental | Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously. Receives: Drug: NNC0113-5840 |
| Placebo matching NNC0113-5840 | Placebo comparator | Participants will receive placebo matched to NNC0113-5840 subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Measured: From time of dosing (day 1) up to day 43
Secondary outcomes (2)
AUC: Area under the NNC0113-5840 plasma concentration time-curve
Measured as hours*nanomole per liter (h*nmol/L)
Measured: From pre-dose (day 1) up to day 43
Cmax: Maximum observed NNC0113-5840 plasma concentration
Measured as nanomoles per liter (nmol/L)
Measured: From pre-dose (day 1) up to day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start1 May 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT07566390
- Sponsor's protocol ID
- NN9695-8150
- Other IDs
- U1111-1328-9401
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC0113-5840 in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07566390
- Acronym / sponsor ID
- NN9695-8150
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 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 purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 NNC0113-5840 | Experimental | Drug: NNC0113-5840Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously. |
| Cohort 2 NNC0113-5840 | Experimental | Drug: NNC0113-5840Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously. |
| Cohort 3 NNC0113-5840 | Experimental | Drug: NNC0113-5840Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously. |
| Cohort 4 NNC0113-5840 | Experimental | Drug: NNC0113-5840Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously. |
| Cohort 5 NNC0113-5840 | Experimental | Drug: NNC0113-5840Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously. |
| Cohort 6 NNC0113-5840 | Experimental | Drug: NNC0113-5840Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously. |
| Placebo matching NNC0113-5840 | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to NNC0113-5840 subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- 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 and visit 2, day -1, as judged by the investigator.
Key exclusion criteria (3 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) [48 millimole per mole (mmol/mol)] 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 |
|---|---|---|
| NNC0113-5840NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin. | Drug | Cohort 1 NNC0113-5840, Cohort 2 NNC0113-5840, Cohort 3 NNC0113-5840, Cohort 4 NNC0113-5840, Cohort 5 NNC0113-5840, Cohort 6 NNC0113-5840 |
| PlaceboPlacebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin. | Drug | Placebo matching NNC0113-5840 |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of dosing (day 1) up to day 43
Measured as number of events.
2 secondary outcomes
AUC: Area under the NNC0113-5840 plasma concentration time-curve
Time frame: From pre-dose (day 1) up to day 43
Cmax: Maximum observed NNC0113-5840 plasma concentration
Time frame: From pre-dose (day 1) up to day 43
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 9 Sep 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 NNC0113-5840 in people with Obesity and Overweight, run by Novo Nordisk A/S at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 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. 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?
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?
Number of treatment emergent adverse events (TEAEs) (time frame: From time of dosing (day 1) up to day 43). 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 9 Sep 2026.