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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
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.
Artemis Insitute for Clin Res
San Diego, California, United States
RECRUITINGPharmaDev Clinical Research Institute LLC
Miami, Florida, United States
RECRUITINGEssence MD Research
Naples, Florida, United States
NOT_YET_RECRUITINGRenstar Medical Research
Ocala, Florida, United States
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)
Measures as number of participants
Time frame: From baseline (week 0) to (week 80)
Change in sleep apnoea specific hypoxic burden (SASHB)
Measured as percentage minutes per hour (%min/h).
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 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.
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 obstructive sleep apnoea (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 obstructive sleep apnoea (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 obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (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)
Chage 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 % 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
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Conquest Research
Atlanta, Georgia, United States
RECRUITINGPhysicians Research Associates
Lawrenceville, Georgia, United States
RECRUITINGUniversity Of Chicago
Chicago, Illinois, United States
NOT_YET_RECRUITINGWeil Cornell Medicine
New York, New York, United States
NOT_YET_RECRUITINGCTI Clinical Research Center
Cincinnati, Ohio, United States
RECRUITINGClinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, United States
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