Not yet recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )

This research study, called SUPREME-02, is testing a new injection, CBL-514, designed to reduce fat under the skin in the tummy area. It's a large-scale study, meaning many people will participate, to confirm if the injection is effective and safe. Participants will be adults with moderate to severe tummy fat and will receive up to four injections, given once every four weeks. Some participants will receive the active study drug, while others will receive a dummy injection (placebo) – neither they nor their doctors will know which one they’re getting. This helps researchers get clear results. The study aims to gather important information about this potential new treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Caliway Biopharmaceuticals Co., Ltd.

Enrolment target

320

Start

01 Oct 2026

Estimated completion

01 Oct 2027

Subcutaneous Fat

What is this study about?

This study is looking into a potential new treatment called CBL-514, which comes as an injection. The main goal of this research is to see if this injection can safely and effectively reduce stubborn fat under the skin in the tummy area. Many people find it hard to get rid of this type of fat, even with diet and exercise.

To make sure the results are fair and accurate, the study is set up in a special way. It's a 'randomised' study, which means people are put into groups by chance, like flipping a coin. Some will get the active CBL-514 injection, and others will get a 'placebo', which is a dummy injection containing only salt water. Neither you nor your study doctor will know which one you're getting. This helps scientists to truly understand the effects of the active drug.

This is a 'Phase 3' study, which means the treatment has already been tested in smaller groups of people and shown some promise. Now, researchers need to give it to a larger group to confirm its effectiveness and safety before it could potentially be made available to more people. By joining, you'd be helping scientists learn more about this new treatment option.

Key takeaways

This study investigates an injection (CBL-514) for tummy fat reduction.
It's a Phase 3 study, meaning it's a larger trial to confirm safety and effectiveness.
Participants will get up to four injections over several weeks.
Some will receive the active drug, others a dummy injection (placebo).
Eligibility depends on specific health and fat criteria.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Your body weight should be at least 50 kg, and your Body Mass Index (BMI) should be between 18.5 and 30. You also need to have abdominal fat that your doctor and you both consider moderate or severe, and you should be bothered by this fat.

There are also some reasons why you might not be able to join. For instance, if you are pregnant, breastfeeding, or planning to get pregnant, or if you have certain health conditions like blood clotting problems, poorly controlled diabetes, or serious heart issues. If you have an extreme fear of needles or injections, or if you've recently had surgery or treatments in your tummy area, you might not be suitable.

This study is open to both men and women who fit these criteria and are willing to follow the study rules. It's important to discuss all your health conditions and medications with the study team to see if this study is right 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 or older?
Do you have moderate or severe tummy fat that bothers you?
Is your BMI between 18.5 and 30, and do you weigh at least 50 kg?
Are you willing to maintain a stable lifestyle during the study?
Are you comfortable with injections and able to attend regular clinic visits?
Are you NOT pregnant, breastfeeding, or planning a pregnancy soon (if female)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of about 320 adults. You could receive up to four treatments with the study drug, given as an injection under the skin in your tummy area. Each injection will be given once every four weeks. You'll need to visit the study clinic regularly for these injections and for check-ups. During these visits, the study team will monitor your health, assess your tummy fat, and ask questions about how you’re feeling. You'll also be asked to keep your lifestyle stable throughout the study. The total duration of your participation will include these treatment periods and follow-up visits.

Potential risks and benefits

Participating in a study like this can have potential benefits, such as receiving a new investigational treatment that might help reduce your tummy fat, or getting regular health check-ups related to the study. However, there are also potential risks, like side effects from the injection, which will be carefully explained to you by the study team. You might experience some discomfort or bruising at the injection site, or other possible side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Investigational Site 1
Verified postcode
Encinitas, United States
Investigational site 2
Verified postcode
Aventura, United States
Investigational Site 3
Verified postcode
Alpharetta, United States
Investigational Site 4
Verified postcode
Hunt Valley, United States
Investigational site 5
Verified postcode
Omaha, United States
Investigational site 6
Verified postcode
New York, United States
Investigational Site 7
Verified postcode
Canal Winchester, United States
Investigational site 8
Verified postcode
Nashville, United States
Investigational site 9
Verified postcode
Austin, United States
Investigational Site 10
Verified postcode
Arlington, United States
Investigational Site 11
Verified postcode
Seattle, United States
Investigational site 12
Verified postcode
Melbourne, Australia

Common questions

What is CBL-514?

CBL-514 is a new injection being studied to see if it can reduce fat under the skin in the tummy area.

Will I definitely get the actual drug?

You might get the active CBL-514 injection or a dummy injection (placebo). Neither you nor your doctor will know which one you receive during the study.

How many injections will I receive?

You could receive up to four injections, given once every four weeks.

Will this injection replace diet and exercise?

No, you'll need to maintain a stable lifestyle, including diet and exercise, throughout the study.

Who is paying for this study?

The study is sponsored by the company developing CBL-514, aiming to research its effectiveness and safety.

How to find out more

Shannon Wu

cr@caliway.com.tw +886-2-26971355 Official trial record

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