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A study to evaluate the efficacy and safety of zenagamtide in people 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 is being conducted to evaluate the effectiveness and safety of a medication called NNC0487-0111, which contains the active substance zenagamtide. The research focuses on individuals living with overweight or obesity, which refers to having excess body weight, and knee osteoarthritis, a condition involving the wear and tear of the joints in the knee that can cause discomfort. The investigation aims to determine if the study drug can assist in weight reduction and the management of joint-related pain.

Participants in the study will receive either the test medication or a placebo. The medication is administered through a subcutaneous injection, which means it is delivered into the fatty layer of tissue just under the skin, using a pre-filled pen once per week. During the study, changes in body weight, waist size, and various health measurements will be monitored. Additionally, the impact on knee pain, stiffness, and physical movement will be observed to see how the treatment affects daily function.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    The study involves receiving either the test medicine, known as zenagamtide, or a placebo, which is a substance with no active medicine.

    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 layer of skin under the skin.

    The administration of the injection occurs once weekly.

  2. Step 2

    Monitoring of health and weight

    Changes in body weight and body mass index (a measure of body fat based on height and weight) are tracked.

    The waist circumference is measured to monitor changes in body shape.

    Measurements are taken for blood pressure, including systolic (the pressure when the heart beats) and diastolic (the pressure when the heart rests) levels.

    Blood tests are conducted to check lipids, which include cholesterol (total, high-density, low-density, and very low-density) and triglycerides (a type of fat in the blood).

    Levels of high-sensitivity C-reactive protein (a marker of inflammation in the body), glycated haemoglobin (a measure of average blood sugar), and fasting plasma glucose (blood sugar levels after not eating) are monitored.

    The physical function and stiffness in the knees are evaluated using specific scales.

  3. Step 3

    Assessment of knee pain

    The intensity of knee pain is recorded using a numerical rating scale.

    The use of pain medication is tracked, including the amount used and whether there is an increase, decrease, or no change in its use.

    Any rescue analgesics, which are medicines used to relieve pain when other treatments are insufficient, are noted during the washout period (a time when previous medications are cleared from the body).

Who can join the trial?

10 criteria

  • You must be a male or female based on the sex you were assigned at birth.
  • You must be 18 years of age or older when you sign the consent form to join the study.
  • You must have a Body Mass Index (BMI) of CCI kg/m2 or higher. Body Mass Index (BMI) is a measurement used to determine if a person is at a healthy weight for their height by comparing weight and height.
  • Your weight must meet the specific BMI requirement of CCI.
  • You must have a medical diagnosis of knee osteoarthritis. Osteoarthritis is a condition where the protective cartilage that cushions the ends of the bones wears down over time.
  • Your knee condition must show radiographic changes, meaning changes visible on an X-ray, specifically Kellgren Lawrence (KL) grades 2 to 3. These grades are used by doctors to describe the severity of joint damage seen on imaging.
  • The target knee, which is the knee that causes you the most pain or your dominant leg if pain is equal, must show these changes.
  • You must have felt pain in your target knee for more than 90 days before the study begins, and that pain must have occurred for more than 15 days within the last 30 days.
  • You must be willing to complete a 72-hour washout period of analgesics. A washout period means stopping a specific medication for a set amount of time so it is no longer in your body. Analgesics are medications used to relieve pain.
  • During the washout period, you are only allowed to use a specific amount of acetaminophen (a common pain reliever) as rescue medication, which is extra medicine taken only when pain becomes too much to handle, up to 24 hours before specific study visits.

Who cannot join the trial?

6 criteria

  • A blood test shows a glycated haemoglobin (HbA1c) level of 6.5% or higher, which is a measurement used to show your average blood sugar levels over the past few months.
  • You have a medical history of type 1 or type 2 diabetes mellitus, which are conditions where your body has trouble managing blood sugar.
  • You have used certain medications for weight or blood sugar control, such as GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, or amylin analogues, in the 6 months before starting the study.
  • You have had a joint prosthesis or joint replacement, which means a man-made part has been put into your knee to replace a damaged joint.
  • You have had arthroscopy, which is a surgery to look inside a joint using a small camera, or received injections into your knee within the last 90 days.
  • You have any other joint diseases in the knee being studied, such as gout or pseudogout, which are types of painful joint inflammation caused by crystals building up in the joint.
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Investigated drugs

Zenagamtide is an experimental medication administered as an injection under the skin. It is being studied to see how well it can help people who are overweight or have obesity, as well as those suffering from knee osteoarthritis, by helping to reduce body weight and manage knee pain.

What is already known about the treatment

Zenagamtide - This medication is an experimental treatment provided as a solution for injection through a pre-filled pen and is administered by a small needle under the skin once a week. Currently being studied in clinical trials, it is being investigated for its potential to help people manage weight and reduce pain caused by knee osteoarthritis. It works by targeting specific hormone receptors in the body to control appetite and influence metabolism at a molecular level. This substance is classified as a metabolic hormone receptor agonist.

Investigated diseases

  • Obesity

    This condition occurs when an individual has accumulated excessive amounts of body fat. It is often characterized by a high body mass index. The condition can develop over time due to various factors affecting energy balance. It may lead to metabolic changes throughout the body.

  • Osteoarthritis of the knee

    This is a joint disease that involves the gradual breakdown of the protective cartilage located at the ends of the bones in the knee. As the cartilage wears away, the bones may rub against each other, causing pain and stiffness. The condition typically progresses slowly over many years. It can result in decreased physical function and mobility in the affected joint.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520444-42-00Protocol codeNN9490-8026Estimated enrolment400 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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