AMAZE 12: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight maintain their weight loss

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

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

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2025-523804-62-00

WHO UTN

U1111-1327-1477

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To confirm superiority of NNC0487-0111 CCI versus placebo on change in body weight in participants with obesity

Secondary objectives 19

1. To confirm superiority of NNC0487-0111 CCI versus placebo on change in body weight in participants with obesity
2. CCI
3. CCI
4. CCI
5. To confirm superiority of NNC0487-0111 CCI versus placebo on change in waist circumference in participants with obesity
6. To confirm superiority of NNC0487-0111 CCI versus placebo on change in systolic blood pressure (SBP) in participants with obesity
7. To confirm superiority of NNC0487-0111 CCI versus placebo on change in physical functioning in participants with obesity
8. To confirm superiority of NNC0487-0111 CCI versus placebo on change in physical functioning in participants with obesity
9. To compare the effect of NNC0487-0111 CCI C versus placebo in participants with obesity on: Body weight Body mass index (BMI)
10. To investigate the effect of NNC0487-0111 CCI in participants with obesity on: Body weight BMI
11. CCI
12. To compare the effect of NNC0487-0111 CCI versus placebo in participants with obesity on: Glucose metabolism Diastolic blood pressure (DBP) Lipids High-sensitivity C-reactive protein (hsCRP)
13. To investigate the effect of NNC0487-0111 CCI in participants with obesity on: Glucose metabolism DBP Lipids hsCRP
14. To investigate the effect of NNC0487-0111 CCI on change in waist circumference in participants with obesity
15. To investigate the effect of NNC0487-0111 CCI on change in SBP in participants with obesity
16. To compare the effect of NNC0487-0111 CCI versus placebo on physical functioning and weight-related quality of life in participants with obesity
17. CCI
18. To investigate the safety and tolerability of NNC0487-0111 as an adjunct to reduced-calorie diet and increased physical activity in participants with obesity
19. To compare the safety and tolerability of NNC0487-0111 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. Male or female (sex at birth).
2. Age between 18 CCI years CCI at the time of signing informed consent.
3. Body Mass Index (BMI) ≥ CCI kg/m2.
4. CCI

Exclusion criteria 3

1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
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 20

1. Relative change in body weight
2. CCI
3. CCI
4. CCI
5. Change in waist circumference
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. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) Physical functioning score
9. Change in body weight
10. Change in body mass index (BMI)
11. CCI
12. Change in glycated haemoglobin (HbA1c)
13. Change in fasting plasma glucose (FPG)
14. Change in fasting insulin
15. Change in diastolic blood pressure (DBP)
16. 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
17. Change in high-sensitivity C-reactive protein (hsCRP)
18. Change in IWQOL-Lite-CT: Physical composite score Psychosocial composite score Total score
19. CCI
20. 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 7

Locations

8 EU/EEA countries · 47 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 82 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