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NCT07509307·Phase 3·INTERVENTIONAL

AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Status

Recruiting

Phase

Phase 3

Enrollment

400

Locations

81

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Interventions

Treatment arms and agents.

DRUG

NNC0487-0111

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

DRUG

Placebo (matched to NNC0487-0111)

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Timeline

From registration to results.

  1. First posted

    Apr 3, 2026

  2. Study start

    Apr 20, 2026

  3. Primary completion

    Aug 14, 2028

  4. Study completion

    Aug 14, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 9, 2026

Outcomes

What the study measures.

Primary outcomes

Relative change in body weight

Time frame · From baseline (week 0) to week 80

Measured as percentage change in body weight.

Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score

Time frame · From baseline (week 0) to week 80

WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.

Secondary outcomes

Change in WOMAC physical function score

Time frame · From baseline (week 0) to week 80

WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for physical function ranges 0-100, where higher score indicates worse physical function. Measured as score on a scale.

Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

Time frame · From baseline (week 0) to week 80

SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6. Measured as score on a scale.

Change in body weight

Time frame · From baseline (week 0) to week 80

Measured as kilograms (kg).

Change in body mass index (BMI)

Time frame · From baseline (week 0) to week 80

Measured as kilograms per meter squared (kg/m\^2).

Change in WOMAC stiffness score

Time frame · From baseline (week 0) to week 80

WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for stiffness ranges 0-100, where higher score indicates worse stiffness. Measured as score on a scale.

Change in WOMAC total score

Time frame · From baseline (week 0) to week 80

WOMAC is a PRO measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Total score ranges 0-100, where higher score indicates worse pain, stiffness, physical function and overall osteoarthritis related disability. Measured as score on a scale.

Change in waist circumference

Time frame · From baseline (week 0) to week 80

Measured as centimetres (cm).

Change in systolic blood pressure (SBP)

Time frame · From baseline (week 0) to week 80

Measured as millimetre of mercury (mmHg).

Change in diastolic blood pressure (DBP)

Time frame · From baseline (week 0) to week 80

Measured as mmHg.

Ratio to baseline: change in total cholesterol

Time frame · From baseline (week 0) to week 80

Measured as ratio.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Key Inclusion Criteria: * Male or female (sex at birth) * Age 18 years or above at the time of signing the informed consent * Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence \[KL\] grades 2 to 4 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 * 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 * 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 grams (g)/day is allowed as rescue medication up until 24 hours before those visits) Key Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records * 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 * Any joint prosthesis or joint replacement in target knee * Arthroscopy or injections into target knee within the last 90 days prior to screening * Any other joint disease in target knee including gout and pseudogout

Study locations

81 registered sites.

Australia · Bulgaria · Canada · Denmark · Greece · Italy · Poland · Puerto Rico · Spain · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.

Neighborhood Healthcare

Escondido, California, United States

First Valley Medical Group

Lancaster, California, United States

Desert Oasis Healthcare

Palm Springs, California, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Westside Center For Clinical Research

Jacksonville, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Advanced Res for Health Improve

Naples, Florida, United States

Clinical Investigation Spec Gurnee

Gurnee, Illinois, United States

Evanston Premier Hlthcr Res

Skokie, Illinois, United States

Monroe Biomedical Research, LLC

Louisville, Kentucky, United States

Arcturus Healthcare, PLC.

Troy, Michigan, United States

Clinvest Research

Springfield, Missouri, United States

NYU Langone Orthopedic Center

New York, New York, United States

Hospital For Special Surgery

New York, New York, United States

Piedmont Healthcare/Research

Statesville, North Carolina, United States

Northwest Research Center

Portland, Oregon, United States

Mercy Family Clinic

Dallas, Texas, United States

Health Res of Hampton Roads

Newport News, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Emeritus Research Sydney

Botany, New South Wales, Australia

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales, Australia

Kolling Institute

St Leonards, New South Wales, Australia

Heart of Australia

Chelmer, Queensland, Australia

Coastal Digestive Health

Maroochydore, Queensland, Australia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Amycretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.