AMAZE 1: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight 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

7 May 2026 → ongoing

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-520440-42-00

WHO UTN

U1111-1313-6262

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 obesity

Secondary objectives 28

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 change in waist circumference in participants with obesity
5. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in systolic blood pressure (SBP) in participants with obesity
6. To confirm superiority of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in physical functioning in participants with obesity
7. CCI
8. To confirm superiority of 00 mg, 00 mg, 00mg, 00 mg NNC0487-0111, each versus placebo on change in physical functioning in participants with obesity
9. CCI
10. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with obesity on: Body weight Body mass index (BMI)
11. CCI
12. To compare the effect of 00 mg, 00 mg, 00mg, 00 mg NNC0487-0111, each versus placebo in participants with obesity on: Weight-related quality of life CCI CCI
13. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo group in participants with obesity on: Glucose metabolism Diastolic blood pressure Lipids High-sensitivity C-reactive protein (hsCRP)
14. CCI
15. To compare the safety and tolerability of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with obesity
16. Extension phase secondary objectives are as follows: To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with obesity
17. CCI
18. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with obesity on: Body weight Body mass index (BMI)
19. CCI
20. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on physical functioning and weight-related quality of life in participants with obesity
21. CCI
22. CCI
23. CCI
24. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in waist circumference in participants with obesity
25. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo on change in systolic blood pressure (SBP) in participants with obesity
26. To compare the effect of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo group in participants with obesity on: Glucose metabolism Diastolic blood pressure Lipids High-sensitivity C-reactive protein (hsCRP)
27. CCI
28. To compare the safety and tolerability of 00 mg, 00 mg, 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with obesity

Conditions and MedDRA coding

Obesity

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 4

1. 1. Male or female (sex at birth).
2. 2. Age 18CCI years CCI at the time of signing the informed consent.
3. 3. Body Mass Index (BMI) CCI kg/m2 .
4. 4. CCI

Exclusion criteria 3

1. 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
2. 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
3. 3. 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 46

1. CCI
2. CCI
3. CCI
4. Change in waist circumference
5. Change in systolic blood pressure (SBP)
6. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
7. CCI
8. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning scorea
9. CCI
10. Change in body weight
11. Change in body mass index (BMI)
12. CCI
13. Change in IWQOL-Lite-CT Physical composite score Psychosocial composite score Total score
14. CCI
15. CCI
16. CCI
17. Change in glycated haemoglobin (HbA1c)
18. Change in fasting plasma glucose (FPG)
19. Change in fasting insulin
20. Change in diastolic blood pressure (DBP)
21. 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
22. Change in high-sensitivity C-reactive protein (hsCRP)
23. CCI
24. CCI
25. Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation
26. Extension phase secondary endpoints are as follows: Relative change in body weight
27. CCI
28. Change in body weight
29. Change in body mass index (BMI)
30. CCI
31. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
32. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT): Physical composite score Physical functioning score Psychosocial composite score Total score
33. CCI
34. CCI
35. CCI
36. CCI
37. Change in waist circumference
38. Change in systolic blood pressure (SBP)
39. Change in glycated haemoglobin (HbA1c)
40. Change in fasting plasma glucose (FPG)
41. Change in fasting insulin
42. Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglyceride
43. Change in high-sensitivity C-reactive protein (hsCRP)
44. CCI
45. CCI
46. Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation

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 11

Locations

4 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 52 files

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

Application history

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