Obesity, Overweight, Obstructive Sleep Apnoea
Conditions
Brief summary
This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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.
Interventions
DRUGNNC0487-0111
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female (sex at birth) * Age 18 years or above at the time of signing informed consent * Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening Key
Exclusion criteria
* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records * Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy * Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence * Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to (week 80) | Measured as percentage (%) change in body weight. |
| Change in apnoea-hypopnoea index (AHI) | From baseline (week 0) to (week 80) | Measured as events/hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in AHI | From baseline (week 0) to (week 80) | Measured as percentage change in AHI. |
| Achievement of 50% reduction in AHI (Yes/No) | From baseline (week 0) to (week 80) | Measured as number of participant. |
| Achievement of: AHI less than (<) 5 | From baseline (week 0) to (week 80) | Measured as number of participants. |
| Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No) | From baseline (week 0) to (week 80) | Measures as number of participants |
| Change in sleep apnoea specific hypoxic burden (SASHB) | From baseline (week 0) to (week 80) | Measured as percentage minutes per hour (%min/h). |
| Change in ESS score | From baseline (week 0) to (week 80) | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score | From baseline (week 0) to (week 80) | 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 wakefulness 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. |
| Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score | From baseline (week 0) to (week 80) | 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. |
| Change in body weight | From baseline (week 0) to (week 80) | Measured as kilogram (Kg). |
| Change in body mass index (BMI) | From baseline (week 0) to (week 80) | Measured as kilograms per meter square (kg/m\^2). |
| Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) | From baseline (week 0) to (week 80) | Measured as number of participants. |
| Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No) | From baseline (week 0) to (week 80) | Measured as number of participants. |
| Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No) | From baseline (week 0) to (week 80) | Measured as number of participants. |
| Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No) | From baseline (week 0) to (week 80) | Measured as number of participants. |
| Change in waist circumference | From baseline (week 0) to (week 80) | Measured as centimetre (cm). |
| Change in neck circumference | From baseline (week 0) to (week 80) | Measured as cm. |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to (week 80) | Measured as millimetre of mercury (mmHg). |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to (week 80) | Measured as mmHg. |
| Change in high-sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to (week 80) | Measured as ratio to baseline |
| Change in Total cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in High-density lipoprotein (HDL) cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in Low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Chage in Very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in Non-HDL cholesterol | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in Triglycerides | From baseline (week 0) to (week 80) | Measured as ratio to baseline. |
| Change in fasting plasma glucose | From baseline (week 0) to (week 80) | Measured as millimoles per litre (mmol/L). |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to (week 80) | Measured as % of HbA1c. |
| Number of Treatment emergent adverse events (TEAEs) | From baseline (week 0) to week 84 | Measured as events. |
| Number of Treatment emergent serious adverse events (TESAEs) | From baseline (week 0) to week 84 | Measured as Events. |
| Number of TEAEs leading to permanent treatment discontinuation | From baseline (week 0) to week 84 | Measured as events. |
Countries
Australia, China, Denmark, Germany, India, Poland, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed