AMAZE 4: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight and obstructive sleep apnoea treated with positive airway pressure lose weight and improve sleep apnoea

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

4 May 2026 → ongoing

Decision date (initial)

2026-03-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-520443-16-00

WHO UTN

U1111-1313-6538

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

1. To confirm superiority of 00 mg, 00 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
2. To confirm superiority of 00 mg, 00 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 14

1. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on relative change in AHI in participants with overweight or obesity, and OSA on PAP therapy
2. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on clinically meaningful change in AHI in participants with overweight or obesity, and OSA on PAP therapy
3. To confirm superiority of 00 mg, 00 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
4. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on ancillary polysomnography (PSG) derived sleep parameters in participants with overweight or obesity, and OSA on PAP therapy
5. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on daytime sleepiness in participants with overweight or obesity, and OSA on PAP therapy
6. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on sleep-related impairment in participants with overweight or obesity, and OSA on PAP therapy
7. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on sleep disturbance in participants with overweight or obesity, and OSA on PAP therapy
8. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and OSA on PAP therapy on: Body weight Body mass index (BMI)
9. To compare the effect of 00 mg,00 mg NNC0487-0111, each versus placebo on reduction of the severity of OSA and its associated medical problems in participants with overweight or obesity, and OSA on PAP therapy
10. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo on withdrawal of PAP therapy in participants with overweight or obesity, and OSA on PAP therapy
11. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and OSA on PAP therapy on: Waist circumference Neck circumference Systolic blood pressure Diastolic blood pressure
12. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and OSA on PAP therapy on: Lipids High-sensitivity C-reactive protein (hsCRP)
13. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and OSA on PAP therapy on: Glucose metabolism
14. To compare the safety and tolerability of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and OSA on PAP therapy

Conditions and MedDRA coding

Overweight or obesity, and obstructive sleep apnoea treated with positive airway preassure (PAP)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Male or female (sex at birth).
2. 2. Age 18 years or above at the time of signing informed consent.
3. 3. CCI
4. 3. CCI
5. 5. 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 5

1. 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
2. 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
3. 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. 4. Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence.
5. 5. 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 CCI before screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Relative change in body weight
2. Change in apnoea-hypopnoea index (AHI)

Secondary endpoints 20

1. Relative change in AHI
2. Achievement of 50% reduction in AHI (Yes/No)
3. Achievement of: AHI < 5 or AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)
4. Change in sleep apnoea specific hypoxic burden (SASHB)
5. Change in ESS score
6. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score
7. Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score
8. Change in body weight
9. Change in body mass index (BMI)
10. Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) ≥ 5 and < 15/hour = mild (Yes/No) ≥ 15 and < 30/hour = moderate (Yes/No) ≥ 30/hour = severe (Yes/No)
11. Withdrawal of positive airway pressure (PAP) therapy (Yes/No)
12. Change in waist circumference
13. Change in neck circumference
14. Change in systolic blood pressure (SBP)
15. Change in diastolic blood pressure (DBP)
16. Change in high-sensitivity C-reactive protein (hsCRP)
17. Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides
18. Change in fasting plasma glucose
19. Change in glycated haemoglobin (HbA1c)
20. Number of: Treatment emergent adverse events (TEAEs) Treatment emergent serious adverse events (TESAEs) TEAEs leading to permanent treatment discontinuation

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 8

Locations

3 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 28 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications