AMAZE 8

Not yet recruitingPhase 3

AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)

Lead sponsor

Novo Nordisk A/S

Assets

Amycretin / zenagamtide / Semaglutide

Listed sites

120

Recruiting sites

—

Enrollment

1,000

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 IDNCT07400107

Org study IDNN9490-8028

Secondary ID2024-520446-31European Medical Agency (EMA)

Secondary IDU1111-1313-8017World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-02-10actual

Last update posted2026-03-12actual

Study start2026-05-20estimated

Primary completion2028-12-12estimated

Study completion2029-01-26estimated

Assets

Investigational agents

Amycretin / zenagamtide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

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.

•Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.

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

Key Exclusion Criteria:

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (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) within 180 days before screening or are expected to require treatment within 180 days 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 randomization. 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 (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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

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 and week 104

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 104

BMI, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants with 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

Number of participants with 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) measured as millimole per liter (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 FPG measured as milligrams per deciliter (mg/dL)

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

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

ratio, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Ratio to baseline: 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 (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

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

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

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

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline: change in non-HDL cholesterol

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

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline: change in triglycerides

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

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

hs-CRP, change

ratio, improvement

LOINC 30522-7

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 84 and week 109

Treatment-emergent AEs (any)

event count, descriptive

Secondary/protocol endpoint

Number of Treatment Emergent Serious Adverse Events (TESAEs)

Time frame:From baseline (week 0) to week 84 and week 109

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 109

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)

Time frame:From baseline (week 0) to week 84 and week 109

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 84 and week 109

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.