DelfaGLP-1 Atlas

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AMAZE 12

RecruitingPhase 3

AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

72

Recruiting sites

64

Enrollment

600

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 IDNCT07503210
Org study IDNN9490-8559
Secondary ID2025-523804-62European Medical Agency (EMA)
Secondary IDU1111-1327-1477World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-03-31actual
Study start2026-04-21actual
Last update posted2026-06-02actual
Primary completion2028-06-06estimated
Study completion2028-07-04estimated

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female (sex at birth).
•Age 18 years or above at the time of signing the informed consent.

Exclusion criteria

•Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% [48 millimoles 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 (43)

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
18
Weight & body composition
8
Glycemic / diabetes
6
Safety / tolerability / PK
6
Patient-reported / QoL
5

Weight & body composition

8 endpoints
Primary/protocol endpoint

Relative change in body weight

Time frame:From week 40 to week 92

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:From week 0 to week 92

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From week 40 to week 92

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From week 40 to week 92

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:From week 40 to week 92

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From week 0 to week 92

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:From week 0 to week 92

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From week 0 to week 92

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From week 40 to week 92

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From week 40 to week 92

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting insulin

Time frame:From week 40 to week 92

ratio, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:From week 0 to week 92

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:From week 0 to week 92

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change in fasting insulin

Time frame:From week 0 to week 92

ratio, improvement

Cardiometabolic biomarkers

18 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From week 40 to week 92

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP)

Time frame:From week 40 to week 92

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in total cholesterol

Time frame:From week 40 to week 92

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High-density lipoprotein (HDL) cholesterol

Time frame:From week 40 to week 92

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low-density lipoprotein (LDL) cholesterol

Time frame:From week 40 to week 92

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very low-density lipoprotein (VLDL) cholesterol

Time frame:From week 40 to week 92

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in non-HDL cholesterol

Time frame:From week 40 to week 92

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in triglycerides

Time frame:From week 40 to week 92

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

Time frame:From week 40 to week 92

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in DBP

Time frame:From week 0 to week 92

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in total cholesterol

Time frame:From week 0 to week 92

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in HDL cholesterol

Time frame:From week 0 to week 92

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in LDL cholesterol

Time frame:From week 0 to week 92

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in VLDL cholesterol

Time frame:From week 0 to week 92

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in non-HDL cholesterol

Time frame:From week 0 to week 92

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in triglycerides

Time frame:From week 0 to week 92

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in hsCRP

Time frame:From week 0 to week 92

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in SBP

Time frame:From week 0 to week 92

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

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 week 40 to week 92

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 week 40 to week 92

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: physical composite score

Time frame:From week 40 to week 92

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: psychosocial composite score

Time frame:From week 40 to week 92

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: total score

Time frame:From week 40 to week 92

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From week 0 to week 40

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Time frame:From week 0 to week 40

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of TEAEs leading to permanent treatment discontinuation

Time frame:From week 0 to week 40

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of TEAEs

Time frame:From week 40 to week 96

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of TESAEs

Time frame:From week 40 to week 96

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of TEAEs leading to permanent treatment discontinuation

Time frame:From week 40 to week 96

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.