Comparing the efficacy and safety of KAI-9531 and semaglutide in people living with obesity who do not have diabetes

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What is this study about?

This study aims to evaluate the effectiveness and safety of a new medication for people living with Obesity who do not have Diabetes. The research compares the performance of the investigational drug KAI-9531 against both semaglutide and a placebo. Obesity is a medical condition characterized by an excessive amount of body fat that may impact health.

Participants in this trial will receive subcutaneous injection, which is a method of delivering medication into the fatty layer of the skin just below the surface. The treatment KAI-9531 or semaglutide will be administered once every week. The study is designed to observe changes in body weight and other health factors over a period of time.

Who Can Join the Study?

You must have a Body Mass Index (BMI) of 35 or higher. Body Mass Index (BMI) is a measurement used to determine if a person is at a healthy weight for their height by comparing weight and height.
You must have tried to lose weight through diet and exercise at least once in the last 6 months and found that it was not successful.
This study is open to both males and females.
You must fall within the specific age range required for this study, which includes adults.

Who Cannot Join the Study?

Having a current diagnosis or a past history of diabetes mellitus, which is a condition that affects how your body turns food into energy.
Having used semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP, or glucagon receptor agonists (types of medications used for weight or blood sugar control) within the 3 months before the study begins.
Starting any medications in the 3 months before the study that could lead to significant weight gain, such as tricyclic antidepressants, atypical antipsychotics, or mood stabilizers (medicines used to treat mental health conditions).
Having unstable weight, which means your body weight changed by more than 5% based on what you reported in the 3 months before the study begins.
A personal or family history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer (specific types of tumors related to the glands in your body or the thyroid in your neck).
Having uncontrolled hypertension, which is high blood pressure that is not being managed, or unstable cardiovascular disease, which refers to heart conditions that are not steady or well-managed.
A history of pancreatitis, which is inflammation of the pancreas, whether it happened long-term (chronic) or suddenly (acute).
Having a known problem with how your stomach empties, such as gastroparesis (slow stomach emptying), gastric outlet obstruction (a blockage in the stomach area), inflammatory bowel disease, or irritable bowel syndrome, or taking medicines that affect GI motility (the movement of food through your digestive system).
A history of attempting suicide.
A history of significant or unstable Major Depressive Disorder (a severe form of depression) or other serious psychiatric disorders (mental health conditions).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD	Pleven	Bulgaria
Futuremeds Sp. z o.o.	Wroclaw	Poland
Diab Serwis Popenda Sp. j.	Chorzow	Poland

Other Sites

Site Name	City	Country
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Diamedical Medical Center 2013 Ltd.	Dimitrovgrad	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Pratia S.A.	Skorzewo	Poland
Sylaqgwaxozuuyu Plevryhw Ljefaspz Dqxtdijivkltq Ldfefpih Cdqgttbe i Ojzkfbmg	Kielce	Poland
Eemkinsbmyy Ckgwwt Ocq	Sofia	Bulgaria
Cvcsmee Mbogdmik Jngyrrx Seg z osuk	Warsaw	Poland
Mihucfe Cyntbsjljb Dfszlqq Eyob	Sofia	Bulgaria
Dwkacejtcr Ctvjvoplywbo Clgeph Eewpoe Ogh	Varna	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	25.06.2026
Poland	Not yet recruiting	25.06.2026

Trial locations

Investigated drugs:

KAI-9531 is an experimental medication being tested in this study to see how well it helps people with obesity lose weight. It is administered as an injection.

Semaglutide is a medication used as a comparison in this study to evaluate its effectiveness in helping participants reduce their body weight. It is administered as an injection under the skin.

Investigated diseases:

Obesity

Obesity – Obesity is a condition characterized by an excessive accumulation of body fat. It occurs when the amount of energy taken in through food exceeds the energy used by the body. Over time, this imbalance leads to an increase in body mass and adipose tissue. The condition can progress through various stages of increasing weight gain. It often involves changes in metabolic processes and body composition.

Trial ID:

2025-523511-11-00

Protocol code:

K9531-3107

NCT ID:

NCT07284979

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparing the efficacy and safety of KAI-9531 and semaglutide in people living with obesity who do not have diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?