AMAZE 2: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight and type 2 diabetes lose weight

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

13 May 2026 → ongoing

Decision date (initial)

2026-05-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-520441-23-00

WHO UTN

U1111-1313-6325

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and type 2 diabetes (T2D)

Secondary objectives 10

1. CCI
2. CCI
3. CCI
4. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on waist circumference in participants with overweight or obesity, and T2D
5. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in haemoglobin A1c in participants with overweight or obesity, and T2D
6. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on systolic blood pressure in participants with overweight or obesity, and T2D
7. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on physical functioning in participants with overweight or obesity, and T2D
8. CCI
9. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on physical functioning in participants with overweight or obesity, and T2D
10. CCI

Conditions and MedDRA coding

Overweight or obesity, and type 2 diabetes

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Male or female (sex at birth).
2. 2. Age 18 years or above at the time of signing informed consent.
3. 3. BMI CCI kg/m2.
4. 4. CCI
5. 5. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
6. 6. 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) for at least CCI before screening.
7. 7. Haemoglobin A1c (HbA1c) 7-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening.

Exclusion criteria 5

1. 1. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 (2021 CKD-EPI formula), at screening.
2. 2. Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within180 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 randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
3. 3. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question.
4. 4. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
5. 5. 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 within CCI before screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relative change in body weight

Secondary endpoints 38

1. CCI
2. CCI
3. CCI
4. Change in waist circumference
5. Change in haemoglobin A1c (HbA1c)
6. Change in systolic blood pressure (SBP)
7. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
8. CCI
9. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea
10. CCI
11. Change in body weight
12. Change in body mass index (BMI)
13. Change in IWQOL-Lite-CT Physical Psychosocial Total score
14. CCI
15. CCI
16. CCI
17. CCI
18. CCI
19. Achievement of HbA1c < 7.0% (Yes/No)
20. Achievement of HbA1c ≤ 6.5% (Yes/No)
21. Achievement of HbA1c < 5.7% (Yes/No)
22. Change in fasting plasma glucose (FPG)
23. Change in fasting insulin
24. Change in urinary albumin-to-creatinine ratio (UACR)
25. Change in diastolic blood pressure
26. Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol TriglycerideS
27. Change in high-sensitivity C-reactive protein (hsCRP)
28. CCI
29. CCI
30. CCI
31. CCI
32. CCI
33. CCI
34. Number of Treatment Emergent Adverse Events (TEAEs)
35. Number of Treatment Emergent Serious Adverse Events (TESAEs)
36. Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation
37. Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)
38. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 10

Locations

5 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 41 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications