AMAZE 5: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight and knee osteoarthritis lose weight and reduce pain

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

15 Apr 2026 → ongoing

Decision date (initial)

2026-04-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2024-520444-42-00

WHO UTN

U1111-1313-6585

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

1. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and knee osteoarthritis (OA)
2. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in knee OA related pain in participants with overweight or obesity and knee OA

Secondary objectives 12

1. CCI
2. CCI
3. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in WOMAC physical function in participants with overweight or obesity and knee OA
4. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning in participants with overweight or obesity, and knee OA
5. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and knee OA on: Body weight Body mass index (BMI)
6. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and knee OA on: WOMAC Stiffness and WOMAC total score
7. CCI
8. To compare the effect of 00 mg, 0 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and knee OA on: Waist circumference Systolic blood pressure (SBP) Diastolic blood pressure (DBP)
9. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and knee OA on: Lipids High-sensitivity C-reactive protein (hsCRP)
10. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo on glucose metabolism in participants with overweight or obesity, and knee OA
11. To compare the effect of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and knee OA on: Use of allowed rescue analgesics during washout period Pain medication use Knee pain intensity (Numerical Rating Scale (NRS))
12. To compare the safety and tolerability of 00 mg, 00 mg NNC0487-0111, each versus placebo in participants with overweight or obesity, and knee OA

Conditions and MedDRA coding

Overweight or obesity, and knee osteoarthritis

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 the informed consent.
3. 3. Body mass index (BMI) ≥ CCI kg/m2 at screening.
4. 4. CCI
5. 5. Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg.
6. 6. Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
7. 7. Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 g/day is allowed as rescue medication up until 24 hours before those visits).

Exclusion criteria 6

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.
4. 4. Any joint prosthesis or joint replacement in target knee.
5. 5. Arthroscopy or injections into target knee within the last 90 days prior to screening.
6. 6. Any other joint disease in target knee including gout and pseudogout.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Relative change in body weight
2. Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

Secondary endpoints 23

1. CCI
2. CCI
3. Change in WOMAC physical function score
4. Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
5. Change in body weight
6. Change in body mass index (BMI)
7. Change in WOMAC stiffness score
8. Change in WOMAC total score
9. CCI
10. Change in waist circumference
11. Change in systolic blood pressure (SBP)
12. Change in diastolic blood pressure (DBP)
13. Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol and Triglycerides
14. Change in high-sensitivity C-reactive protein (hsCRP)
15. Change in glycated haemoglobin (HbA1c)
16. Change in fasting plasma glucose (FPG)
17. Use of allowed rescue analgesics during washout period (Yes/no)
18. Amount of allowed rescue analgesics used during washout period
19. Use of pain medication (Yes/No)
20. Amount of pain medication used
21. Change in pain medication (decrease/no change/increase)
22. Change in knee pain intensity (NRS)
23. 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

6 EU/EEA countries · 40 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 60 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