AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living with Obesity Who Do Not Have Diabetes

This research study is investigating a new medication called KAI-9531 for adults who are living with obesity but do not have diabetes. The study aims to see if KAI-9531 can help people lose weight and improve their health, compared to a widely used medicine called Wegovy (semaglutide) and a placebo (a dummy treatment with no active medicine). Participants will receive one of these treatments, and researchers will carefully track their weight changes, waist size, and other health markers over 76 weeks. The main goal is to find out how much weight people lose with KAI-9531 and to ensure it is safe to use. This could potentially offer another option for managing obesity in the future.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Kailera Therapeutics Inc.

Enrolment target

268

Start

29 Apr 2026

Obesity

What is this study about?

This study is trying to find out if a new medicine, KAI-9531, can help people living with obesity to lose weight. We know that carrying extra weight can sometimes lead to other health problems. This study is specifically for adults who have obesity but do not have a diagnosis of diabetes. The researchers want to compare KAI-9531 with a medicine already available called Wegovy, which is known to help with weight loss, and also with a 'placebo'. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers understand if any changes are truly due to the new medicine or other factors.

Over 76 weeks (about a year and a half), the study will closely monitor participants to see how their weight changes. They'll also look at things like waist size, blood pressure, cholesterol levels, and general wellbeing. By comparing KAI-9531 to both an existing treatment and a placebo, the study hopes to get a clear picture of how effective KAI-9531 is and whether it's a safe option for people needing support with weight management.

The information gathered from this study is really important because it could lead to new ways to help people manage their weight and improve their overall health. Every participant's contribution helps us learn more about obesity and potential treatments.

Key takeaways

This study explores a new medicine (KAI-9531) for weight loss in adults with obesity, who don't have diabetes.
It compares KAI-9531 to an existing medicine (Wegovy) and a dummy treatment (placebo).
Participation involves regular clinic visits and health checks over 76 weeks.
The main goal is to check how much weight is lost and if the new medicine is safe.
You won't know which treatment you are receiving until after the study is over.
Every participant helps advance our understanding of obesity treatments.

Who may be eligible?

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

Importantly, this study is specifically designed for people who are living with obesity but have not been diagnosed with diabetes. This means if you have diabetes, even type 2, you would not be able to take part in this particular study.

There will be other detailed criteria that the study team will discuss with you, such as your general health and any other medications you are taking, 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?
Do you have a diagnosis of obesity?
Have you *not* been diagnosed with diabetes?
Are you able to attend regular clinic appointments for over a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive one of three treatments: the new medicine KAI-9531, an existing medicine called Wegovy, or a placebo (a dummy treatment). You won't know which one you are receiving, and sometimes the study team might not know either, until the end of the study.

The study involves regular visits to the clinic over a period of 76 weeks (about a year and a half). During these visits, the study team will carry out various checks and assessments. This will include measuring your weight, waist circumference, blood pressure, and taking blood samples to check things like cholesterol levels and how your body is reacting to the treatment. They will also ask you to fill in questionnaires about your quality of life, how you're feeling, and your eating habits.

You would receive your study medicine as an injection, likely administered with a pre-filled pen. The study team will teach you how to do this safely if it's something you need to do at home. Throughout the study, the team will be checking your health and any side effects you might experience. After the 76 weeks of treatment, there will likely be some follow-up appointments to see how you are doing.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new medicine that might help you lose weight and improve your health. You would also receive close medical attention and monitoring throughout the study. However, like all medicines, KAI-9531 and Wegovy can have side effects, which the study team will explain to you in detail. There's also a chance you might receive the placebo and not the active medicine. You are completely free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Poland
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Unverified
Bulgaria

Common questions

What is obesity?

Obesity means having too much body fat, which can affect your health. It's usually measured using something called Body Mass Index (BMI).

What is a 'placebo'?

A placebo is a dummy treatment. It looks exactly like the real medicine but contains no active ingredients. It helps researchers compare if the real medicine is actually working.

Will I know which medicine I'm getting?

No, this is a 'blinded' study. To make sure results are fair, neither you nor possibly the study team will know if you're getting KAI-9531, Wegovy, or the placebo during the study.

How long does the study last?

The main treatment period for the study is 76 weeks, which is about a year and a half. There might be some follow-up appointments after that.

What is Wegovy?

Wegovy is a medicine that is already approved and used to help people with weight loss. It is given as an injection.