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NCT07481630·Phase 3·INTERVENTIONAL

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

82

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and knee osteoarthritis. 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 dose level 1 and dose level 2 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

    Mar 19, 2026

  2. Study start

    Apr 13, 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 (%) of body weight.

Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

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

Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. 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.

Secondary outcomes

Change in WOMAC physical function score

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

Measured as score on a scale. Physical function score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse physical function.

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

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

Measured as score on a scale. 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, that is 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.

Change in body weight

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

Measured as kilogram (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)

Measured as score on a scale. Stiffness score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse stiffness.

Change in WOMAC total score

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

Measured as score on a scale. Total score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Total score ranges from 0-100 and higher scores indicate worse overall osteoarthritis- related disability.

Change in waist circumference

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

Measured as centimetre (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.

Change in total cholesterol

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

Measured as ratio to baseline.

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 (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. * Symptomatic knee OA with first appearance of pain in the target knee more than (\>) 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 gram (g)/day is allowed as rescue medication up until 24 hours before those visits). Exclusion Criteria: * Glycated haemoglobin more than or equal to (≥) 6.5% \[(48 millimoles per mole (mmol/mol)\] 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

82 registered sites.

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

Arizona Research Center, Inc.

Phoenix, Arizona, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Chase Medical Research LLC

Hamden, Connecticut, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Zenith clinical research

Hollywood, Florida, United States

CNS Healthcare

Jacksonville, Florida, United States

Angels Clinical Research Institute

Miami Lakes, Florida, United States

Hope Clin Res & Wellness

Conyers, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

Elite Clinical Trials

Blackfoot, Idaho, United States

MedVadis Research Watertown

Waltham, Massachusetts, United States

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, United States

Great Lakes Medical Research

Westfield, New York, United States

Accellacare and KDCILM, LLC

Wilmington, North Carolina, United States

Coastal Carolina Res Ctr

North Charleston, South Carolina, United States

VIP Trials_San Antonio

San Antonio, Texas, United States

Charlottesville Med Research

Charlottesville, Virginia, 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.

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Put the record in context.

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