A Phase 3 interventional study of NNC0487-0111 and Placebo (matched to NNC0487-0111) in Obesity, Overweight and Obstructive Sleep Apnoea, sponsored by Novo Nordisk A/S. Recruiting at 92 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: NNC0487-0111
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: Placebo (matched to NNC0487-0111)
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Relative change in body weight
Measured as percentage (%) change in body weight.
Time frame: From baseline (week 0) to (week 80)
Change in apnoea-hypopnoea index (AHI)
Measured as events/hour.
Time frame: From baseline (week 0) to (week 80)
Relative change in AHI
Measured as percentage change in AHI.
Time frame: From baseline (week 0) to (week 80)
Achievement of 50% reduction in AHI (Yes/No)
Measured as number of participant.
Time frame: From baseline (week 0) to (week 80)
Achievement of: AHI less than (<) 5
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Change in sleep apnoea specific hypoxic burden (SASHB)
measured as %min/h (percentage minutes per hour).
Time frame: From baseline (week 0) to (week 80)
Change in ESS score
Measured as score on a scale. ESS measures the level of daytime sleepiness or average sleep propensity. The measure consists of 8 items yielding one total score. Total score ranges from 0-24. Higher scores indicate higher sleepiness or average sleep propensity in daily life.
Time frame: From baseline (week 0) to (week 80)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
Measured as score on a scale. PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakeful-ness associated with sleep problems or impaired alertness. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1). Higher scores indicate more sleep-related impairment.
Time frame: From baseline (week 0) to (week 80)
Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1). Higher scores indicate more sleep disturbance.
Time frame: From baseline (week 0) to (week 80)
Change in body weight
Measured as kilogram (Kg).
Time frame: From baseline (week 0) to (week 80)
Change in body mass index (BMI)
Measured as kilograms per meter square (kg/m\^2).
Time frame: From baseline (week 0) to (week 80)
Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No)
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Improvement in OSA severity category: ≥ 15 and < 30/hour = moderate (Yes/No)
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Improvement in OSA severity category: ≥ 30/hour = severe (Yes/No)
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Withdrawal of positive airway pressure (PAP) therapy (Yes/No)
Measured as number of participants.
Time frame: From baseline (week 0) to (week 80)
Change in waist circumference
Measured as centimetre (cm).
Time frame: From baseline (week 0) to (week 80)
Change in neck circumference
Measured as cm.
Time frame: From baseline (week 0) to (week 80)
Change in systolic blood pressure (SBP)
Measured as millimetre of mercury (mmHg).
Time frame: From baseline (week 0) to (week 80)
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From baseline (week 0) to (week 80)
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in Total cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in High-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in Low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in Very low-density lipoprotein (VLDL) cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in Non-HDL cholesterol
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in Triglycerides
Measured as ratio to baseline.
Time frame: From baseline (week 0) to (week 80)
Change in fasting plasma glucose
Measured as millimoles per litre (mmol/L).
Time frame: From baseline (week 0) to (week 80)
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) of HbA1c.
Time frame: From baseline (week 0) to (week 80)
Number of Treatment emergent adverse events (TEAEs)
Measured as events.
Time frame: From baseline (week 0) to week 84
Number of Treatment emergent serious adverse events (TESAEs)
Measured as Events.
Time frame: From baseline (week 0) to week 84
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Time frame: From baseline (week 0) to week 84
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jun 2028, 25 months after the start.
Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 25 months is above that.
Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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