OverweightPhase 1NCT07757087
A Research Study to See How NNC0487-0111 Affects the Body's Energy Use After a Weight Loss in Adults Living With Overweight or Obesity, Compared to a Low-calorie Diet or Placebo
A Phase 1 study testing NNC0487-0111 and LED in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
The purpose of this clinical study is to evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity or overweight following weight loss. This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NNC0487-0111 and LED
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Aug 2026to 18 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or older at the time of signing the informed consent.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Exposure to an investigational medicinal product within 30 days.
- Any condition, or disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, for example, an imminent job change to/from a physically demanding occupation.
- Claustrophobia or severe discomfort of being confined in small rooms.
- History of type 1 or type 2 diabetes mellitus.
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- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal (GI), or endocrinological conditions.
- Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
- Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to 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 issue.
- Physical activity of moderate to vigorous intensity for greater than (>) 4 hours/week within the past 6 months before screening.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, 8200
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University-NUTRIM-Dep Human Biology-Obesity
Maastricht, 6211 LK
About this study
Official title: The Effect of Once-weekly Subcutaneous NNC0487-0111 Compared to an Energy-restricted Diet or Placebo on Energy Metabolism in Adults Living With Overweight or Obesity: a Randomised, Placebo-controlled Study
The purpose of this clinical study is to evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity or overweight following weight loss. This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants receiving placebo (without weight loss).
- Conditions
- Overweight, Obesity
- Being tested
- NNC0487-0111, Placebo, LED
- 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.
PlaceboDrug
Placebo matched to NNC0487-0111 will be administered subcutaneously.
LEDBehavioural
A meal plan and meal replacements will be provided by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 | Experimental | Participants will receive once weekly subcutaneous injection of NNC0487-0111. Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Participants will receive once weekly subcutaneous injection of placebo matched to NNC0487-0111. Receives: Drug: Placebo |
| Low Energy Diet (LED) | Other | Participants will receive a low-energy dietary designed to achieve a reduction in body weight. Receives: Behavioral: LED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleeping metabolic rate (SMR)
Measured in kilojoules per day (kJ/day)
Measured: Baseline (week 0) to week 12-26
Secondary outcomes (4)
Change in 24-hour energy expenditure (EE)
Measured in kJ/day.
Measured: Baseline (week 0) to week 12-26
Change in basal metabolic rate (BMR)
Measured in kJ/day.
Measured: Baseline (week 0) to week 12-26
Change in resting metabolic rate (RMR)
Measured in kJ/day.
Measured: Baseline (week 0) to week 12-26
Change in diet-induced thermogenesis (DIT)
Measured in kJ/day.
Measured: Baseline (week 0) to week 12-26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start3 Aug 2026
- Primary completion18 Sep 2028 (estimated)
- Study completion18 Sep 2028 (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
- 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
- NCT07757087
- Sponsor's protocol ID
- NN9490-8152
- Other IDs
- U1111-1324-2934, 2025-522744-40, 2025
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Once-weekly Subcutaneous NNC0487-0111 Compared to an Energy-restricted Diet or Placebo on Energy Metabolism in Adults Living With Overweight or Obesity: a Randomised, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07757087
- Acronym / sponsor ID
- NN9490-8152
- Conditions
- Overweight, 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
- 3 Aug 2026 (actual)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- 18 Sep 2028 (estimated)
- First posted
- 11 Aug 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 evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity or overweight following weight loss. This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants receiving placebo (without weight loss).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111Participants will receive once weekly subcutaneous injection of NNC0487-0111. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once weekly subcutaneous injection of placebo matched to NNC0487-0111. |
| Low Energy Diet (LED) | Other | Behavioral: LEDParticipants will receive a low-energy dietary designed to achieve a reduction in body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or older at the time of signing the informed consent.
Key exclusion criteria (11 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Exposure to an investigational medicinal product within 30 days.
- Any condition, or disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, for example, an imminent job change to/from a physically demanding occupation.
- Claustrophobia or severe discomfort of being confined in small rooms.
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. | Drug | NNC0487-0111 |
| PlaceboPlacebo matched to NNC0487-0111 will be administered subcutaneously. | Drug | Placebo |
| LEDA meal plan and meal replacements will be provided by the investigators. | Behavioural | Low Energy Diet (LED) |
Primary outcome
Change in sleeping metabolic rate (SMR)
Time frame: Baseline (week 0) to week 12-26
Measured in kilojoules per day (kJ/day)
4 secondary outcomes
Change in 24-hour energy expenditure (EE)
Time frame: Baseline (week 0) to week 12-26
Change in basal metabolic rate (BMR)
Time frame: Baseline (week 0) to week 12-26
Change in resting metabolic rate (RMR)
Time frame: Baseline (week 0) to week 12-26
Change in diet-induced thermogenesis (DIT)
Time frame: Baseline (week 0) to week 12-26
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 1 Oct 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0487-0111 and LED in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in 2 countries.
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 2 inclusion and 11 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 1 Oct 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 Denmark, Netherlands. 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?
Change in sleeping metabolic rate (SMR) (time frame: Baseline (week 0) to week 12-26). 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 1 Oct 2026.