Not recruiting

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

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 1 step.

Step 1
Study participation and medication administration
Once the study begins, an injection is administered once weekly.
The medication received is either KAI-9531, semaglutide (brand name wegovy), or a placebo (a substance with no active medicine).
The injections are given subcutaneously, which means they are injected into the fatty tissue just under the skin.
The study continues for a total of 76 weeks to monitor changes in body weight.

Who can join the trial?

4 criteria

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 trial?

10 criteria

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).

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Verified
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Plovdiv, Bulgaria

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Semaglutide
This medication is an approved treatment used to help manage weight in individuals living with obesity. It is administered as a subcutaneous injection, meaning it is injected just under the skin once a week using a pre-filled pen. As a glucagon-like peptide-1 receptor agonist, it works by mimicking a natural hormone that tells the brain to feel full and slows down digestion. This biological process helps to reduce appetite and control food intake.
KAI-9531
This is an experimental substance currently being studied in clinical trials for the treatment of obesity. It is provided as a solution for injection to be administered under the skin. While its specific clinical status is still under investigation, it is designed to act on metabolic pathways to assist with weight management. It belongs to a class of investigative therapeutic agents aimed at addressing nutritional and metabolic diseases.

Investigated diseases

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.