Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

J1I-MC-GZBJ: A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1); J1I-MC-GOA1: Indication-Specific Appendix (ISA2) for participants with knee osteoarthritis (OA)

This research study is testing a new medicine called Retatrutide. It's for adults aged 18 and over who are overweight or have obesity. A special part of the study is also looking at how this medicine might help people who have knee arthritis, a condition that causes pain and stiffness in the knee. The study wants to find out if Retatrutide can help people lose weight and also reduce their knee pain. Some people will receive the new medicine, while others will get a placebo (a dummy injection with no medicine) to compare the results. This is a large study (Phase 3), which means it's testing if the medicine is effective and safe before it could potentially be approved for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Eli Lilly & Co.

Enrolment target

440

Start

28 Sep 2023

Obesity Overweight Osteoarthritis Knee

What is this study about?

This important study, known as TRIUMPH-1, is exploring a new weekly injection called Retatrutide. The main aim is to find out if this medicine can help adults who are overweight or have obesity to lose weight. Being overweight or having obesity can lead to various health problems, so finding new and effective ways to manage weight is very important.

A special part of this study, called ISA2, is specifically looking at how Retatrutide might benefit people who also suffer from knee osteoarthritis. This is a common condition where the cartilage in the knee joint wears down, leading to pain, stiffness, and difficulty moving. Researchers want to see if, besides helping with weight loss, the medicine can also ease the pain associated with knee arthritis.

This is a large-scale study, called a 'Phase 3' trial. This means it's one of the final steps in testing a new medicine. It involves many people and aims to confirm that the medicine is both effective at what it's supposed to do and safe to use, compared to a placebo. The results of studies like this are crucial in deciding whether a new medicine can become widely available.

Key takeaways

Tests a new weekly injection, Retatrutide, for weight management.
Also investigates if Retatrutide helps knee pain from arthritis.
Compares the new medicine to a placebo (dummy injection).
It's a large, controlled study involving adults 18 and over.
Participation includes regular clinic visits and health monitoring.

Who may be eligible?

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

You would be considered for the main part of the study if you are overweight or have obesity. This is usually determined by your Body Mass Index (BMI).

Additionally, a specific group within the study is looking for people who not only meet the overweight/obesity criteria but also have knee osteoarthritis. This means you would have been diagnosed with arthritis in your knee and experience related pain.

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?
Are you currently considered overweight or to have obesity?
Have you been diagnosed with osteoarthritis in your knee?
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, you'll be randomly chosen to receive either the new medicine (Retatrutide) or a placebo injection (which looks like the medicine but contains no active drug). You and your study doctor won't know which one you're getting. You'll receive these injections once a week.

Throughout the study, you'll have regular visits to the clinic for various checks. These visits will include measuring your body weight to see how it changes over time. If you are part of the knee arthritis group, you will also complete questionnaires about your knee pain to track any improvements. The study will involve several assessments to monitor your health and safety. The total duration of the study, including follow-up, will be determined by the specific study plan, but clinical trials often last for many months to a couple of years.

Potential risks and benefits

Taking part in a study like this means you might benefit from the new medicine if it proves effective for weight loss or knee pain. However, there's also a chance you might receive the placebo and not experience any direct benefits from the study drug. All medicines have potential side effects, and you would be closely monitored for any unwanted effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Romania
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Unverified
Poland
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Unverified
Hungary
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Unverified
Spain

Common questions

What is Retatrutide?

Retatrutide is a new medicine being tested as a weekly injection to help with weight loss, and potentially to ease knee pain for people with arthritis.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but does not contain any active drug. It helps researchers compare the effects of the new medicine.

Why is this study 'double-blind'?

Double-blind means neither you nor your study doctor will know if you're getting the active medicine or the placebo. This helps ensure the results are unbiased and accurate.

Will I have to pay to be in the study?

No, you will not have to pay for the study drug or any study-related tests and appointments.

How long will I be in the study?

The study lasts for a significant period, typically many months to potentially a couple of years, with regular visits and follow-ups to monitor your health.