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A Study of Orforglipron for Knee Pain Relief in Adults with Obesity or Overweight 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 involves people who have obesity or are overweight and also have osteoarthritis of the knee. Osteoarthritis is a condition where the cushioning cartilage in the joints wears down over time, causing pain and stiffness. The study will test a medicine called Orforglipron, which is also known by its code name LY3502970. This medicine comes in tablet form and is taken by mouth once daily. Some people in the study will receive Orforglipron while others will receive placebo. The purpose of the study is to find out if Orforglipron is better than placebo at reducing knee pain in people who have both weight problems and knee osteoarthritis.

During the study, people will take either Orforglipron tablets or placebo tablets once each day for up to 72 weeks. The study will measure knee pain using a scoring system that asks questions about pain levels during different activities. Doctors will compare the changes in pain scores between people taking Orforglipron and those taking placebo to see if the medicine helps reduce knee pain. People in the study will need to be willing to stop taking certain pain medications throughout the entire study period.

The study is designed to help researchers understand whether this new medicine can help people who struggle with both excess weight and painful knee osteoarthritis. People joining the study should have tried to lose weight through diet at least once before without success. The study will look at how safe the medicine is and whether it works well for reducing the knee pain that comes with osteoarthritis in people who are overweight or have obesity.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period begins

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive orforglipron hemicalcium tablets, and the other group will receive placebo tablets that look identical but contain no active medication.

    You will not know which group you are in, and neither will your study doctor. This is called a double-blind study design.

  2. Step 2

    Daily medication intake

    You will take your assigned medication once daily by mouth.

    If you are in the active treatment group, you will receive orforglipron hemicalcium tablets. The dose will be adjusted to the maximum tolerated dose, which means the highest dose that you can take without experiencing unacceptable side effects.

    The tablets are taken orally, meaning you swallow them by mouth.

  3. Step 3

    Medication restrictions

    Throughout the entire study period, you will need to stop taking certain pain medications as instructed by your study doctor.

    This requirement applies for the full duration of your participation in the study.

  4. Step 4

    Regular assessments

    During the study, your knee pain will be assessed using a questionnaire called the WOMAC pain subscale.

    WOMAC stands for Western Ontario and McMaster Universities Osteoarthritis Index. This questionnaire measures how much pain you experience in your knee during various activities.

    The study will measure changes in your pain levels from the beginning of the study to later time points.

  5. Step 5

    Safety monitoring

    Throughout the study, your safety will be monitored through regular check-ups and assessments.

    Any side effects or changes in your health will be recorded and evaluated by the study team.

  6. Step 6

    Study completion

    You will continue taking the study medication and attending scheduled visits until the study is completed.

    The study is expected to run until approximately May 2028, though your individual participation duration may vary.

Who can join the trial?

6 criteria

  • You must have obesity, which means having too much body fat, or be overweight, which means weighing more than what is considered healthy for your height
  • You must have tried to lose weight by changing your eating habits at least one time in the past, but you were not able to lose weight successfully
  • You must have osteoarthritis of the knee, which is a condition where the cushioning tissue in your knee joint wears down over time, causing pain and stiffness
  • You must be willing to stop taking certain pain relief medicines for the entire time you are in the study
  • You must be an adult, meaning you are at least 18 years old
  • Both men and women can participate in this study

Who cannot join the trial?

3 criteria

  • The source data does not contain specific exclusion criteria for this clinical trial
  • Exclusion criteria are reasons why someone cannot join a study, such as having certain other medical conditions, taking specific medications, or having particular test results that would make participation unsafe or affect the study results
  • Without detailed exclusion criteria provided in the source data, it is not possible to list the specific reasons why a patient might not be able to participate in this particular study
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Investigated drugs

  • Orforglipron

    is an investigational medication being studied as a once-daily treatment for people who have obesity or are overweight and also suffer from osteoarthritis of the knee. This medication is being tested to see if it can help reduce knee pain and improve symptoms associated with osteoarthritis while also addressing weight management. Participants in the study will take the highest dose they can tolerate to determine if it works better than placebo at reducing pain.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in the study as a comparison to help researchers understand whether orforglipron actually works or if any improvements are simply due to other factors.

What is already known about the treatment

Orforglipron – Orforglipron is an investigational medication currently being studied in clinical trials for the treatment of obesity or overweight in people who also have osteoarthritis of the knee. It is taken orally once daily and works by targeting specific molecular pathways involved in weight management and metabolic regulation. The main goal of the research is to determine if orforglipron can reduce knee pain associated with osteoarthritis while helping patients achieve weight loss, which may further improve joint symptoms. This medication belongs to a class of drugs designed to regulate appetite and body weight through hormonal mechanisms in the body.

Investigated diseases

Osteoarthritis – Osteoarthritis is a joint disease that occurs when the protective cartilage that cushions the ends of bones gradually breaks down over time. As the cartilage wears away, bones begin to rub against each other, causing pain, stiffness, and swelling in the affected joints. The condition most commonly affects joints in the hands, knees, hips, and spine. Symptoms typically develop slowly and worsen over time, making it harder to move the joint and perform daily activities. The joint may lose its normal shape and small pieces of bone may break off and float in the joint space. People with osteoarthritis often experience pain during or after movement, tenderness when pressure is applied to the joint, and reduced flexibility in the affected area.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522631-34-00Protocol codeJ2A-MC-GZPTEstimated enrolment800 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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