Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
This research study is investigating a new medication called Ribupatide. It's designed for people who are living with obesity and don't have diabetes. The main goal is to see if taking Ribupatide as a weekly injection helps people lose more weight compared to another common obesity medication, Semaglutide, or a dummy treatment (placebo). Researchers will also be checking the safety of Ribupatide. If you've tried to lose weight before with diet and exercise without success, and meet certain health criteria, you might be able to take part. The study aims to find better ways to help people manage their weight.
At a glance
What is this study about?
This clinical trial is exploring a new medicine called Ribupatide to help people who are living with obesity. It's designed for those who don't have diabetes. Many people find it hard to lose weight and keep it off, even with diet and exercise. This study aims to find out if Ribupatide, given as a once-weekly injection, could be a more effective option.
The main purpose of the study is to compare Ribupatide with two other treatments. One is Semaglutide, which is already used to help with weight management. The other is a 'placebo', which looks like the study medicine but doesn't contain any active ingredients. This helps researchers understand the true effect of Ribupatide. By comparing these, the study hopes to show how well Ribupatide helps people reduce their body weight.
Researchers will be carefully checking how much weight participants lose and will also be looking closely at any side effects or health changes to make sure Ribupatide is safe. Finding new and effective treatments for obesity is important because managing a healthy weight can improve your overall health and reduce the risk of many other conditions.
Key takeaways
- The study is for adults with obesity who do not have diabetes.
- It tests a new weekly injection, Ribupatide, for weight loss.
- Ribupatide is compared to an existing medicine (Semaglutide) and a dummy treatment.
- Participants must have tried to lose weight with diet/exercise without success.
- Regular health checks are part of participating.
Who may be eligible?
To join this study, you would need to be an adult (18 years or older) and living with obesity. Specifically, your Body Mass Index (BMI) would need to be 35 or higher. You should also have tried to lose weight through diet and/or exercise in the last six months without much success.
There are also some reasons why you might not be able to join. For example, if you have diabetes or have a history of certain health problems like specific cancers, severe heart conditions, or some types of pancreatitis. Also, if you've recently started medications that can significantly change your weight, or have recently used certain other weight-loss medications, you wouldn't be eligible.
It's important that your weight has been stable in the last three months (no more than a 5% change). The medical team will check your full health history to make sure the study is a safe and suitable option for you.
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?
- Is your BMI 35 or higher?
- Have you tried to lose weight with diet and exercise in the last 6 months without success?
- Do you NOT have diabetes?
- Have you NOT recently used certain weight-loss medications or started new medicines that affect weight?
- Have you NOT had unstable weight changes (more than 5%) in the last 3 months?
What does participation involve?
If you join the study, you would receive weekly injections of either Ribupatide, Semaglutide, or a placebo (a dummy treatment). You would not know which one you are receiving. You will have regular visits to the clinic so the study team can monitor your health, measure your weight, and check for any side effects. These visits will include checks like blood tests and blood pressure measurements. The total duration of your participation in the study, including the treatment period and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (53)
- Kailera Clinical SiteVerified postcodeGlendale, United States· Recruiting
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Common questions
What is obesity?
Obesity is a medical condition where you have excess body fat that can harm your health. It's usually measured using your Body Mass Index (BMI).
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real study medication but contains no active ingredients. It helps researchers understand the true effects of the new medicine.
Will I know which treatment I'm getting?
No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving Ribupatide, Semaglutide, or the placebo. This helps ensure unbiased results.
What are the injections for?
The injections are how the study medications (Ribupatide, Semaglutide, or placebo) are given. You would receive one injection under the skin each week.
Can I continue my usual diet and exercise?
The study team will discuss diet and exercise guidelines with you. It's usually expected that you continue with recommended healthy lifestyle changes while on the study.
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?
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