Health Condition 1: G473- Sleep apnea
Conditions
Interventions
Intervention1: NNC0487-0111 B: Pharmaceutical form : Solution for injection
Route of administration: Subcutaneous
Trial product strength :
0.80 mg/mL
1.67 mg/mL
3.35 mg/mL
6.7 mg/mLd
13.4 mg/mL
26.8 m
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female (sex at birth). 2. Age 18 years or above at the time of signing informed consent. 3. Body mass index (BMI) greater than or equal to 27.0 kg per m2 at screening. 4. Participant must have a desire and be committed to lose at least 25percent of their body weight. 5. Previously diagnosed moderate-to-severe OSA with an AHI greater than or equal to 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening. 6.9. Currently using positive airway pressure for at least 3 consecutive months prior to screening and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits
Exclusion criteria
Exclusion criteria: 1. Glycated haemoglobin (HbA1c) greater than or equal to 6.5percent (48 mmol per mol) as measured by the central laboratory at screening. 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. 3. 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. 4. Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence. 5. Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1 or gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Relative change in body weight 2. Change in apnoea-hypopnoea index (AHI)Timepoint: From baseline (week 0) to end of treatment (week 80) | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change in AHITimepoint: From baseline (week 0) to end of treatment (week 80);Achievement of 50% reduction in AHI (Yes/No)Timepoint: From baseline (week 0) to end of treatment (week 80);Achievement of: 1. AHI less than 5 or 2. AHI 5-14 with Epworth Sleepiness Scale (ESS) less than or equal to 10 (Yes/No)Timepoint: From baseline (week 0) to end of treatment (week 80);Change in sleep apnoea specific hypoxic burden (SASHB)Timepoint: From baseline (week 0) to end of treatment (week 80);Change in ESS scoreTimepoint: From baseline (week 0) to end of treatment (week 80);Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a scoreTimepoint: From baseline (week 0) to end of treatment (week 80);Change in PROMIS Short Form v1.0 Sleep Disturbance 8b scoreTimepoint: From baseline (week 0) to end of treatment (week 80);Number of: 1. Treatment emergent adverse events (TEAEs) 2. Treatment emergent serious adverse events (TESAEs) 3.TEAEs leading to permanent treatment discontinuationTimepoint: From baseline (week 0) to week 84 | — |
Countries
Australia, Germany, India, Japan, Poland, Spain, Taiwan, Turkey, United States of America
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India Private Limited,
Outcome results
None listed