AMAZE 1

RecruitingPhase 3

AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

Recruiting sites

Enrollment

1,150

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, % 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 IDNCT07339423

Org study IDNN9490-8021

Secondary ID2024-520440-42European Medical Agency (EMA)

Secondary IDU1111-1313-6262World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-01-14actual

Study start2026-02-24actual

Last update posted2026-06-02actual

Primary completion2029-06-26estimated

Study completion2029-08-21estimated

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

•Male or female (sex at birth).

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

•History of at least one self-reported unsuccessful dietary effort to lose body weight.

Key Exclusion Criteria:

•HbA1c ≥ 6.5% (48 millimole per mole [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.

•Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.

Endpoints (25)

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

Cardiometabolic biomarkers

Weight & body composition

Patient-reported / QoL

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

5 endpoints

Primary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to week 84 and week 136

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to week 84 and week 136

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 84 and week 136

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to week 136

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to week 84 and week 136

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (week 0) to week 84 and week 136

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Ratio to baseline: change in fasting insulin

Time frame:From baseline (week 0) to week 84 and week 136

ratio, improvement

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to week 84 and week 136

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 84

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to baseline: change in total cholesterol

Time frame:From baseline (week 0) to week 84 and week 136

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to week 84 and week 136

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to week 84 and week 136

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to week 84 and week 136

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline: change in non-HDL cholesterol

Time frame:From baseline (week 0) to week 84 and week 136

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline: change in triglycerides

Time frame:From baseline (week 0) to week 84 and week 136

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (week 0) to week 84 and week 136

hs-CRP, change

ratio, improvement

LOINC 30522-7

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score

Time frame:From baseline (week 0) to week 84 and week 136

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

Time frame:From baseline (week 0) to week 84 and week 136

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT physical composite score

Time frame:From baseline (week 0) to week 84 and week 136

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT psychosocial composite score

Time frame:From baseline (week 0) to week 84 and week 136

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT total score

Time frame:From baseline (week 0) to week 84 and week 136

IWQOL-Lite total

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 and week 140

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 and week 140

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 and week 140

Discontinuation due to AE

event count, event

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.