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RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

This research study is looking into a new medication called Ribupatide. It's designed for people who are living with obesity or are overweight and also have type 2 diabetes. The main goal is to find out if taking Ribupatide as a weekly injection can help individuals lose weight and improve their blood sugar control (measured by something called HbA1c) better than a placebo, which is an inactive substance. This is a Phase 3 trial, meaning it's a later stage of research, testing the medicine in a larger group of people to confirm its effectiveness and safety before it might become more widely available.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Kailera
Enrolment target
1,156
Start
12 Jan 2026
Estimated completion
24 Apr 2028

What is this study about?

This study is looking into a new treatment called Ribupatide. It's for people who are overweight or have obesity and also live with type 2 diabetes. The aim is to see if this medicine, given as a simple injection once a week, can help people lose weight and improve their blood sugar levels more effectively than an inactive treatment (a 'placebo'). Researchers want to find out how well Ribupatide works and if it's safe to use.

Type 2 diabetes and obesity often go hand in hand, and managing both can be challenging. By improving weight and blood sugar, this new medicine could potentially offer a new way to help people manage these conditions more effectively. The study will compare Ribupatide to a placebo to clearly understand the real effects of the new medicine.

This is a 'Phase 3' study, which means the medicine has already gone through earlier tests and is now being looked at in a larger group of people. This stage is crucial for confirming that the medicine is both effective and safe for potential future use. It's an important step in developing new treatment options for people living with these health conditions.

Key takeaways

  • This study is for people with type 2 diabetes who are also overweight or have obesity.
  • It's testing a new weekly injection called Ribupatide for weight loss and blood sugar control.
  • Participants will receive either Ribupatide or a placebo.
  • Rigorous health checks and monitoring will be part of the study.
  • The study aims to find out if Ribupatide is effective and safe.
  • It's a Phase 3 trial, an important step before potential wider availability.

Who may be eligible?

To join this study, you would need to have been diagnosed with type 2 diabetes. You should also have a body mass index (BMI) of 27 or higher, which means you are considered overweight or have obesity. Your diabetes treatment, which could be diet and exercise alone or with tablets (but not a specific type called DPP-4 inhibitors), must have been stable for at least three months. If you haven't been on medication yet, and your average blood sugar level (HbA1c) is between 6.5% and 7.5%, you might still be able to join. You'd also need to have tried to lose weight through diet and/or exercise in the last six months without success.

There are also some reasons why you might not be able to join. For example, if you have type 1 diabetes, have had severe low blood sugar or diabetes-related emergencies recently, or if you've recently started certain medications that can affect your weight. Other reasons include a history of certain cancers (like medullary thyroid cancer or specific family conditions), uncontrolled high blood pressure, unstable heart problems, or issues with your pancreas or digestive system. If you've had certain mental health conditions, like a recent suicide attempt or severe depression, or if you're currently taking other weight-loss medications or injections for diabetes like semaglutide or tirzepatide, you also wouldn't be able to participate.

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.

  1. Do I have type 2 diabetes?
  2. Is my BMI 27 or higher?
  3. Have I been on stable diabetes treatment (diet/exercise or tablets, but not DPP-4 inhibitors) for at least 3 months, or am I new to treatment with an HbA1c between 6.5% and 7.5%?
  4. Have I tried to lose weight through diet/exercise in the last 6 months without success?
  5. Do I have a history of certain conditions like type 1 diabetes, severe low blood sugar, or specific cancers?
  6. Am I taking other weight-loss medications or certain diabetes injections (like semaglutide)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine, Ribupatide, or a placebo (an inactive substance that looks just like the medicine). You wouldn't know which one you are getting. Both are given as injections under the skin once a week. You would have regular visits to the clinic for health checks, blood tests, and to measure your weight and blood sugar levels. The study involves ongoing follow-up to monitor your health and how you respond to the treatment. The total duration of the study would be explained to you, including the different stages of treatment and monitoring.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are also potential risks, including side effects from the study medication, which may or may not be known yet. The placebo group won't receive the active medicine. You will be fully informed of all known risks before joining, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (116)

  • Kailera Clinical Site
    Verified postcode
    Cullman, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Phoenix, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Sun City, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Little Rock, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Escondido, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Montclair, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Northridge, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Oceanside, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Toluca Lake, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Stamford, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Jupiter, United States· Recruiting
  • Kailera Clinical Site
    Verified postcode
    Miami, United States· Recruiting

Common questions

What is Ribupatide?

Ribupatide is a new investigational medicine being tested to help people with type 2 diabetes who are also overweight or have obesity.

How will the medicine be given?

It will be given as an injection under the skin once a week.

What does 'placebo' mean?

A placebo is an inactive substance that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine has a genuine effect.

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

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving Ribupatide or the placebo.

Can I stop participating if I want to?

Yes, you can withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your regular medical care.

How to find out more

Kailera Therapeutics, Inc.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Efficacy and Safety of Ribupatide Administered Once Weekly i…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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