RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

This research study is testing a new medicine called KAI-9531. This medicine is given as a weekly injection under the skin. We want to find out if it can help people who are overweight or obese lose weight. To join, you also need to have other health problems linked to your weight, such as high blood pressure or sleep apnoea, but you must not have diabetes. We will compare KAI-9531 to a placebo, which is a dummy medicine with no active ingredients. The main goal is to see how much weight people lose with KAI-9531 compared to the placebo. We will also be carefully checking for any side effects to make sure the medicine is safe.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Kailera

Enrolment target

1,800

Start

18 Dec 2025

Estimated completion

27 Mar 2028

Obesity Overweight

What is this study about?

This study is looking into a new treatment called KAI-9531. Many people find it difficult to manage their weight, especially if they have health conditions like high blood pressure or sleep problems that are made worse by being overweight or obese. This research aims to find an effective way to help people in this situation. The medicine is given as a small injection under the skin once a week.

The main purpose of this study is to see if KAI-9531 helps people lose weight. We're also very interested in understanding if it's a safe treatment. To do this, we compare KAI-9531 to a placebo, which looks just like the real medicine but has no active drug in it. This helps us ensure that any changes we see are truly due to KAI-9531 and not other factors.

Finding new and safe ways to help people living with obesity and weight-related health issues is very important for improving their overall health and quality of life. This study is an important step in understanding if KAI-9531 could become a useful option in the future.

Key takeaways

This study is testing a new weekly injection, KAI-9531, for weight loss.
It's for adults who are overweight or obese with other weight-related health issues.
You must not have diabetes to join this specific study.
The study compares KAI-9531 to a placebo to check its effectiveness and safety.
Your participation involves regular clinic visits and health checks.

Who may be eligible?

This study is looking for adults aged 18 or older. To take part, you need to be overweight or obese. This means your Body Mass Index (BMI) should be 30 or higher, or 27 or higher if you also have weight-related health problems like high blood pressure, high cholesterol, sleep apnoea, or heart disease.

We would also like to hear from you if you've tried different diets and exercise programmes to lose weight in the last six months without success. However, it's important that you haven't been diagnosed with diabetes. We’re also unable to include you if you’ve recently changed medications that can affect your weight, or if your weight has changed by more than 5% in the last three months.

There are some other reasons why this study might not be suitable for you. For example, if you have a history of certain serious medical conditions, such as some types of thyroid cancer, uncontrolled high blood pressure, severe mental health conditions, a history of pancreatitis, or have recently used similar weight-loss medications.

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 30 or higher, or 27 or higher with weight-related issues like high blood pressure?
Have you tried to lose weight with diet and exercise recently, but it hasn't worked?
Have you *never* been diagnosed with diabetes?
Have you *not* had large changes in your weight or started new weight-affecting medicines recently?
Do you *not* have a history of serious health conditions like certain cancers, severe heart problems, or pancreatitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive weekly injections, either of the study medicine KAI-9531 or a placebo (a dummy medicine). You won't know which one you're receiving, and neither will your study doctor, to keep the results fair. You will have regular visits to the clinic to check your health, measure your weight, and make sure you're doing okay with the treatment. The study will involve a number of appointments over a period of time, where various assessments like blood tests and physical examinations will be done. You will also be asked to keep a record of your health and any changes you notice. The total duration of your involvement will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in this study might offer you some potential benefits, such as receiving a new medicine that could help with weight loss and receiving regular close medical care. However, there's no guarantee that you will personally benefit from the study, especially if you receive the placebo. As with all medicines, there could be potential risks, known or unknown side effects from KAI-9531. These will be fully explained to you before you decide to join. You are completely free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (44)

Kailera Clinical Site
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Anniston, United States· Recruiting
Kailera Clinical Site
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Birmingham, United States· Recruiting
Kailera Clinical Site
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Cullman, United States· Recruiting
Kailera Clinical Site
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Sun City, United States· Recruiting
Kailera Clinical Site
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Escondido, United States· Recruiting
Kailera Clinical Site
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Toluca Lake, United States· Recruiting
Kailera Clinical Site
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Aurora, United States· Recruiting
Kailera Clinical Site
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Bridgeport, United States· Recruiting
Kailera Clinical Site
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Jupiter, United States· Recruiting
Kailera Clinical Site
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Lilburn, United States· Recruiting
Kailera Clinical Site
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Springfield, United States· Recruiting
Kailera Clinical Site
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Columbia, United States· Recruiting

Common questions

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects accurately.

Why can't I have diabetes to join this study?

This particular study is specifically looking at weight loss in people who do not have diabetes. Future studies might look at how this medicine works for people with diabetes, but for this study, it's an exclusion criteria.

What does 'BMI' mean?

BMI stands for Body Mass Index. It's a number that uses your height and weight to work out if your weight is healthy. A doctor or nurse can help you understand your BMI.

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

No, during the study, neither you nor the doctors will know whether you are receiving KAI-9531 or the placebo. This is called 'blinding' and helps ensure the study results are unbiased.

Can I continue with my usual diet and exercise if I join?

Yes, you would be expected to continue efforts to lose weight through diet and exercise, as the study aims to see if the medicine helps alongside these efforts. The study team will provide more specific guidance.

How to find out more

Kailera Therapeutics, Inc.

info-clinicalstudies@kailera.com 781-317-0291 Official trial record

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