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A study to evaluate the effects of zenagamtide on weight and pain in patients with overweight or obesity and knee osteoarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate how well the investigational drug NNC0487-0111, which contains the substance zenagamtide, works for people living with overweight or obesity and knee osteoarthritis. Knee osteoarthritis is a condition where the protective tissue that cushions the ends of the bones in the knee wears down over time, often leading to pain and stiffness. The study will compare the effects of different doses of this medication against a placebo.

Participants will receive the treatment through a subcutaneous injection, which means the medicine is administered into the fatty layer of tissue just under the skin, using a pre-filled pen once a week. Throughout the study, changes in body weight and levels of pain in the knee will be observed. Other factors such as physical function, waist size, and certain blood measurements like cholesterol and blood pressure may also be monitored to understand the overall impact of the treatment.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    You will receive either a test medicine called zenagamtide or a placebo, which is a substance that does not contain active medication.

    The zenagamtide is provided as a solution for injection in a pre-filled pen and is administered subcutaneously, which means it is injected into the fatty tissue just under the skin.

    The medication is administered once weekly.

  2. Step 2

    Monitoring and assessments

    During the study, changes in body weight and body mass index, which is a measure of body fat based on height and weight, will be recorded.

    Assessments will be made regarding knee osteoarthritis, a condition involving wear and tear in the knee joints, specifically looking at knee pain, stiffness, and physical function.

    Measurements of waist circumference, blood pressure, and blood sugar levels, such as fasting plasma glucose, will be taken.

    blood tests will be performed to check lipids, which include cholesterol and triglycerides, as well as inflammation markers like high-sensitivity C-reactive protein.

    The use of pain medication will be monitored to track any changes in how much medication is needed for relief.

Who can join the trial?

11 criteria

  • Both men and women are eligible to participate.
  • You must be 18 years of age or older when you sign the agreement to join the study.
  • You must have a Body Mass Index (BMI) of at least CCI kg/m2, which is a measure used to determine if a person is overweight or obese based on their height and weight.
  • Your weight must be at least CCI.
  • You must have a medical diagnosis of knee osteoarthritis, which is a condition where the protective tissue (cartilage) at the ends of your bones wears down over time, causing pain and stiffness.
  • Your knee condition must show radiographic changes, meaning changes visible on an X-ray, specifically classified as Kellgren-Lawrence (KL) grades 2 to 4, which describes the severity of the wear and tear in the joint.
  • The study will focus on your target knee, which is the knee that causes you the most pain or your dominant leg if the pain is equal in both knees.
  • Your knee pain must have first started more than 90 days before the study begins.
  • You must have experienced knee pain for more than 15 days during the 30 days leading up to your screening.
  • You must be willing to undergo a 72-hour washout period, which means you must stop taking certain pain-relieving medicines for three days before specific study visits.
  • You are allowed to take acetaminophen (a common pain reliever) up to 4 grams per day as rescue medication, which is medicine used to treat sudden or severe symptoms, as long as it is stopped 24 hours before your scheduled visits.

Who cannot join the trial?

6 criteria

  • Having a glycated haemoglobin (HbA1c) level of 6.5% or higher, which is a blood test that shows your average blood sugar levels over the past few months.
  • Having a history of type 1 or type 2 diabetes mellitus, which are conditions where the body cannot properly control blood sugar levels.
  • Having used glucagon-like-peptide-1 (GLP-1) receptor agonists, dual GLP-1/gastric inhibitory peptide (GIP) RAs, or amylin analogues, which are specific types of medications used to manage blood sugar or weight, within a certain timeframe before the study.
  • Having a joint prosthesis or joint replacement, which means a man-made part has been surgically put into the knee being studied.
  • Having undergone arthroscopy, which is a surgical procedure to look inside a joint using a tiny camera, or having received injections into the knee being studied within the 90 days before the study begins.
  • Having any other joint disease in the knee being studied, such as gout or pseudogout, which are types of painful swelling and inflammation in the joints.
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Investigated drugs

Zenagamtide is a medication administered through a small needle under the skin. In this study, it is being tested to see how well it helps people who are overweight or have obesity to lose body weight and to reduce pain caused by osteoarthritis in the knee.

What is already known about the treatment

  • Zenagamtide

    This medication is an experimental treatment delivered as a solution for injection through a pre-filled pen under the skin. Currently being studied in clinical trials, it is being investigated for its potential to help manage weight in people with overweight or obesity and to reduce pain caused by knee osteoarthritis. It works by targeting specific hormone receptors in the body to help regulate appetite and metabolic processes. This substance is classified as a metabolic hormone analog.

  • Placebo

    A placebo is an inactive substance that contains no medicinal ingredients and is administered in the same way as the test medication to serve as a comparison. It is used in clinical research to ensure that the observed effects of a new drug are actually caused by the drug itself rather than other factors. This substance has no therapeutic effect and does not target any specific molecular processes in the body.

Investigated diseases

  • Obesity

    This is a condition where an individual has accumulated an excessive amount of body fat. It is often characterized by a high body mass index and increased body fat percentage. Over time, the condition can lead to various metabolic changes in the body. It typically develops due to an imbalance between energy intake from food and the energy used by the body.

  • Osteoarthritis

    This is a common joint condition that occurs when the protective tissue at the ends of the bones wears down over time. While it can affect many joints, it frequently impacts the knees. As the cartilage thins, the bones may rub against each other, causing discomfort and stiffness. The condition often progresses gradually, leading to changes in joint structure and movement.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520445-23-00Protocol codeNN9490-8294Estimated enrolment400 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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