AMAZE 3

RecruitingPhase 3

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

Recruiting sites

Enrollment

300

estimated

Study population

Obesity / overweight, Sleep apnea

Key I/E criterion

—

Primary endpoints

•Body weight, % change•AHI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07571005

Org study IDNN9490-8025

Secondary ID2024-520442-36European Medical Agency (EMA)

Secondary IDU1111-1313-6359World Health Organization (WHO)

Timeline

Milestones

Study start2026-05-05actual

Study first posted2026-05-06actual

Last update posted2026-06-02actual

Primary completion2028-07-12estimated

Study completion2028-10-04estimated

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

5 endpoints

Primary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to (week 80)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to (week 80)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:From baseline (week 0) to (week 80)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to (week 80)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in neck circumference

Time frame:From baseline (week 0) to (week 80)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:From baseline (week 0) to (week 80)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to (week 80)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to (week 80)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP)

Time frame:From baseline (week 0) to (week 80)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in high-sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (week 0) to (week 80)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Total cholesterol

Time frame:From baseline (week 0) to (week 80)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to (week 80)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to (week 80)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Chage in Very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to (week 80)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Non-HDL cholesterol

Time frame:From baseline (week 0) to (week 80)

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:From baseline (week 0) to (week 80)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Change in ESS score

Time frame:From baseline (week 0) to (week 80)

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score

Time frame:From baseline (week 0) to (week 80)

change from baseline, improvement

Secondary/protocol endpoint

Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score

Time frame:From baseline (week 0) to (week 80)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Treatment emergent adverse events (TEAEs)

Time frame:From baseline (week 0) to week 84

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment emergent serious adverse events (TESAEs)

Time frame:From baseline (week 0) to week 84

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of TEAEs leading to permanent treatment discontinuation

Time frame:From baseline (week 0) to week 84

Discontinuation due to AE

event count, event

Other clinical outcomes

10 endpoints

Primary/protocol endpoint

Change in apnoea-hypopnoea index (AHI)

Time frame:From baseline (week 0) to (week 80)

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Relative change in AHI

Time frame:From baseline (week 0) to (week 80)

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Achievement of 50% reduction in AHI (Yes/No)

Time frame:From baseline (week 0) to (week 80)

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of: AHI less than (<) 5

Time frame:From baseline (week 0) to (week 80)

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No)

Time frame:From baseline (week 0) to (week 80)

threshold achievement, improvement

componentsAHI, change, PGI, change

Secondary/protocol endpoint

Change in sleep apnoea specific hypoxic burden (SASHB)

Time frame:From baseline (week 0) to (week 80)

change from baseline, improvement

Secondary/protocol endpoint

Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No)

Time frame:From baseline (week 0) to (week 80)

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 5 and < 15/hour = mild (Yes/No)

Time frame:From baseline (week 0) to (week 80)

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 15 and < 30/hour = moderate (Yes/No)

Time frame:From baseline (week 0) to (week 80)

OSA responder

categorical status, improvement

Secondary/protocol endpoint

Improvement in obstructive sleep apnoea (OSA) severity category: ≥ 30/hour = severe (Yes/No)

Time frame:From baseline (week 0) to (week 80)

OSA responder

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.