ObesityPhase 1NCT07508020
A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity
A Phase 1 study testing NNC0487-0111 in people with Obesity, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- NNC0487-0111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 30 Mar 2026to 22 Jan 2028
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female (sex at birth).
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- 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.
- Overweight should be due to excess adipose tissue, as judged by the investigator.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- History of type 1 or type 2 diabetes mellitus.
- Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) at screening.
- Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues.
- Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Parexel International GmbH
Berlin, 14050
About this study
Official title: Effect of Once-weekly Subcutaneous Administration of NNC0487-0111 on Energy Intake, Appetite and Postprandial Metabolism in Participants With Obesity - a Randomised, Placebo-controlled, Double Blinded Study
The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.
- Conditions
- Obesity
- Being tested
- NNC0487-0111, Placebo (matched to 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
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.
Placebo (matched to NNC0487-0111)Drug
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly. Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly. Receives: Drug: Placebo (matched to NNC0487-0111) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126
Measured as percentage change of energy.
Measured: From Baseline to Day 126
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182
Measured as percentage change of energy.
Measured: From Baseline to Day 182
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238
Measured as percentage change of energy.
Measured: From Baseline to Day 238
Secondary outcomes (17)
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126
Measured as kilojoules (kJ).
Measured: From Baseline to Day 126
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182
Measured as kJ.
Measured: From Baseline to Day 182
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238
Measured as kJ.
Measured: From Baseline to Day 238
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126
Measured as grams.
Measured: From Baseline to Day 126
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182
Measured as grams.
Measured: From Baseline to Day 182
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238
Measured as grams.
Measured: From Baseline to Day 238
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378
Measured as percentage change of energy.
Measured: From Baseline to Day 378
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378
Measured as kJ.
Measured: From Baseline to Day 378
Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378
Measured as grams.
Measured: From Baseline to Day 378
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126
Measured as kJ.
Measured: From Baseline to Day 126
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182
Measured as kJ.
Measured: From Baseline to Day 182
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238
Measured as kJ.
Measured: From Baseline to Day 238
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378
Measured as kJ.
Measured: From Baseline to Day 378
Relative change from Day 19 in body weight to Day 131
Measured as percentage change of body weight.
Measured: From Day 19 to Day 131
Relative change from Day 19 in body weight to Day 187
Measured as percentage change of body weight.
Measured: From Day 19 to Day 187
Relative change from Day 19 in body weight to Day 243
Measured as percentage change of body weight.
Measured: From Day 19 to Day 243
Relative change from Day 19 in body weight to Day 383
Measured as percentage change of body weight.
Measured: From Day 19 to Day 383
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start30 Mar 2026
- Primary completion19 Jan 2028 (estimated)
- Study completion22 Jan 2028 (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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT07508020
- Sponsor's protocol ID
- NN9490-8151
- Other IDs
- U1111-1319-9246, 2025-521393-34, 2025
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 27 Apr 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Once-weekly Subcutaneous Administration of NNC0487-0111 on Energy Intake, Appetite and Postprandial Metabolism in Participants With Obesity - a Randomised, Placebo-controlled, Double Blinded Study
- ClinicalTrials.gov ID
- NCT07508020
- Acronym / sponsor ID
- NN9490-8151
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 19 Jan 2028 (estimated)
- Study completion
- 22 Jan 2028 (estimated)
- First posted
- 2 Apr 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 look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly. |
| Placebo | Placebo comparator | Drug: Placebo (matched to NNC0487-0111)Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female (sex at birth).
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- 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.
- Overweight should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (6 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- History of type 1 or type 2 diabetes mellitus.
- Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) at screening.
- Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues.
- Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before 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 |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen. | Drug | NNC0487-0111 |
| Placebo (matched to NNC0487-0111)Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen. | Drug | Placebo |
Primary outcome
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126
Time frame: From Baseline to Day 126
Measured as percentage change of energy.
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182
Time frame: From Baseline to Day 182
Measured as percentage change of energy.
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238
Time frame: From Baseline to Day 238
Measured as percentage change of energy.
17 secondary outcomes
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126
Time frame: From Baseline to Day 126
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182
Time frame: From Baseline to Day 182
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238
Time frame: From Baseline to Day 238
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126
Time frame: From Baseline to Day 126
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182
Time frame: From Baseline to Day 182
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238
Time frame: From Baseline to Day 238
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378
Time frame: From Baseline to Day 378
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378
Time frame: From Baseline to Day 378
Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378
Time frame: From Baseline to Day 378
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126
Time frame: From Baseline to Day 126
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182
Time frame: From Baseline to Day 182
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238
Time frame: From Baseline to Day 238
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378
Time frame: From Baseline to Day 378
Relative change from Day 19 in body weight to Day 131
Time frame: From Day 19 to Day 131
Relative change from Day 19 in body weight to Day 187
Time frame: From Day 19 to Day 187
Relative change from Day 19 in body weight to Day 243
Time frame: From Day 19 to Day 243
Relative change from Day 19 in body weight to Day 383
Time frame: From Day 19 to Day 383
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 27 Apr 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
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 Germany.
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 6 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 27 Apr 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 Germany. 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?
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 (time frame: From Baseline to Day 126). The study lists 3 primary outcomes in all. 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 27 Apr 2026.