AMAZE 2

RecruitingPhase 3

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

Recruiting sites

Enrollment

630

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT07533175

Org study IDNN9490-8024

Secondary ID2024-520441-23European Medical Agency (EMA)

Secondary IDU1111-1313-6325World Health Organization (WHO)

Timeline

Milestones

Study start2026-04-13actual

Study first posted2026-04-16actual

Last update posted2026-06-02actual

Primary completion2028-08-07estimated

Study completion2028-08-07estimated

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

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 informed consent.

•Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening.

•Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.

•Haemoglobin A1c (HbA1c) 7-10% [53-86 (millimoles per mole) mmol/mol] (both inclusive) as measured by the central laboratory at screening.

Exclusion criteria

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (<) 30 milliliter per minute per meter square (mL/min/1.73 m^2) [2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula], at screening.

•Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

•Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

•Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

•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 (29)

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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Renal / kidney

Weight & body composition

4 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)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

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

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)

BMI, change

change from baseline, improvement

Glycemic / diabetes

7 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Achievement of HbA1c < 7.0% (Yes/No)

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Achievement of HbA1c ≤ 6.5% (Yes/No)

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

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Achievement of HbA1c < 5.7% (Yes/No)

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

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) (mmol/L)

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) (mg/dL)

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting insulin

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

ratio, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Change in urinary albumin-to-creatinine ratio (UACR)

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

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

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

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 84)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Total cholesterol

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

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 84)

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 84)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very low-density lipoprotein (VLDL) cholesterol

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

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Non-HDL cholesterol

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

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Patient-reported / QoL

3 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)

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)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score

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

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 88

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 88

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation

Time frame:From baseline (week 0) to week 88

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)

Time frame:From baseline (week 0) to week 88

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of treatment emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Time frame:From baseline (week 0) to week 88

Severe hypoglycemia

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.