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Clinical Trials List

Protocol NumberNN9490-8293

NCT Number(ClinicalTrials.gov Identfier)NCT07571109

Active

2026-05-05 - 2029-01-08

Phase III

Not yet recruiting4

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure (AMAZE 4)

Trial Applicant

NOVO NORDISK PHARMA (TAIWAN) LTD.
Sponsor

Novo Nordisk A/S
Trial scale

Multi-Regional Multi-Center
Update

2026/08/30

Investigators and Locations

Principal Investigator Hai-Hua Chuang 無

Cathay General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Po-Yueh Chen 無

Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pai-Chien Chou 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hsueh-Yu Lee

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Obesity, Obstructive Sleep Apnoea

Objectives

Primary objective - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and obstructive sleep apnoea (OSA) on positive airway pressure (PAP) therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on change in apnoea-hypopnoea index (AHI) in participants with overweight or obesity, and OSA on PAP therapy Secondary objectives - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on relative change in AHI in participants with overweight or obesity, and OSA on PAP therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on clinically meaningful change in AHI in participants with overweight or obesity, and OSA on PAP therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo in achieving OSA remission or mild asymptomatic OSA in participants with overweight or obesity, and OSA on PAP therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on ancillary polysomnography (PSG) derived sleep parameters in participants with overweight or obesity, and OSA on PAP therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on daytime sleepiness in participants with overweight or obesity, and OSA on PAP therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on sleep-related impairment in participants with overweight or obesity, and OSA on PAP therapy - To confirm superiority of 20 mg, 5 mg NNC0487-0111, each versus placebo on sleep disturbance in participants with overweight or obesity, and OSA on PAP therapy - To compare the safety and tolerability of 20 mg, 5 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and OSA on PAP therapy

Test Drug

NNC0487-0111 B

Active Ingredient

Amycretin

Dosage Form

Solution for injection

Dosage

0.80 mg/mL, 1.67 mg/mL, 3.35 mg/mL, 6.7 mg/mL, 13.4 mg/mL, 26.8 mg/mL

Endpoints

Relative change in body weight: From baseline (week 0) to end of treatment (week 80), %
Change in apnoea-hypopnoea index (AHI): From baseline (week 0) to end of treatment (week 80), Events/hour

Inclution Criteria

Main inclusion criteria:
• Male or female (sex at birth).
• Age 18 years or above at the time of signing informed consent.
• Body mass index (BMI) ≥ 27.0 kg/m2 at screening.
• Participant must have a desire and be committed to lose at least 25% of their body weight.
• 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.

Exclusion Criteria

Main 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 within 1 year before screening.

The Estimated Number of Participants

Taiwan

10 participants
Global

305 participants