Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

J1I-MC-GZBN:A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants who have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial

This research study, called J1I-MC-GZBN, is investigating a new weekly injection, LY3437943 (also known as Retatrutide), for people who have knee osteoarthritis and are also overweight or obese. The main goals are to see if this new medicine can help reduce knee pain and lead to weight loss. The study is a "Phase 3" trial, which means it's a larger study designed to confirm if the treatment is effective and safe before it might become widely available. Participants will be randomly assigned to receive either the new drug or a dummy injection (placebo) to fairly compare the results. Doctors will carefully measure changes in knee pain and body weight throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

15 Sep 2023

Overweight Osteoarthritis Knee Obesity

What is this study about?

This study is investigating a new medicine called LY3437943, sometimes referred to as Retatrutide. It's designed for people who experience knee pain due to osteoarthritis and are also overweight or obese. Osteoarthritis is a common condition where the cartilage that cushions your joints wears down over time, leading to pain, stiffness, and swelling. Being overweight or obese can put extra stress on your knee joints, often making osteoarthritis symptoms worse.

The main purpose of this research is to see if taking LY3437943 once a week as an injection can help reduce the pain from knee osteoarthritis and also help people lose weight. The study will carefully compare the new medicine with a "placebo injection," which looks exactly like the study medicine but contains no active drug. This is important to ensure that any improvements seen are truly due to the medicine itself and not other factors.

This is a "Phase 3" study, which means it's one of the final steps in testing a new medicine. Before a new drug can be approved for general use, it needs to go through several phases of testing. Phase 3 trials involve a larger number of people and aim to confirm the medicine's effectiveness, monitor side effects, and gather information that will allow it to be used safely.

Key takeaways

This study is testing a new weekly injection for knee osteoarthritis and weight management.
It aims to reduce knee pain and promote weight loss.
You would be assigned to either the new medicine or a dummy injection.
Regular clinic visits and health checks would be required.
It's a Phase 3 study, meaning it's a crucial step before potential general availability.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

You would also need to have been diagnosed with osteoarthritis in your knee and be considered overweight or obese. This study is specifically looking at how the new medicine helps with both these conditions.

The research team will have a more detailed list of things they look for to make sure the study is right for you and that you meet all the necessary health requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with osteoarthritis in your knee?
Are you currently considered overweight or obese?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: one receiving the new weekly injection (LY3437943) or one receiving a dummy injection (placebo). You won't know which one you're getting, nor will your study doctor.

Throughout the study, you would have regular visits to the clinic where study staff will check your health, ask about your knee pain, measure your weight, and administer your weekly injection. They might also do blood tests or other assessments to see how you're responding to the treatment. There will be follow-up appointments after you stop taking the study medication to monitor your health. The total duration of your participation, including treatment and follow-up, will be explained in full detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer medical attention and potentially seeing an improvement in your knee pain or body weight from the new medicine. However, there's always a chance the new treatment might not help you, or you could experience side effects. These could be mild, like irritation at the injection site, or more serious. The study team will explain all known side effects. Remember, joining any research study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is osteoarthritis?

Osteoarthritis is a common joint condition where the protective cartilage on the ends of your bones wears down over time, leading to pain, stiffness, and swelling.

What does 'placebo-controlled' mean?

It means some people in the study will receive the new medicine, while others will receive a dummy injection (placebo) that looks the same but contains no active drug. This helps researchers fairly compare how well the new medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, this is a "double-blind" study, meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps make the study results more reliable.

What are the main things the study wants to find out?

The study mainly wants to see if the new weekly injection can reduce knee pain from osteoarthritis and help people lose weight.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your standard medical care.