KAI-9531 in Adults With Obesity or Overweight and Diabetes

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What is this study about?

This study is being done in obesity and diabetes to see whether KAI-9531, given as a subcutaneous injection once a week, can help lower body weight and improve blood sugar control. The trial also includes placebo. HbA1c is a blood test that shows average blood sugar over the past few months.

People in the study are assigned by chance to receive either KAI-9531 or placebo, and neither the participants nor the study team know which one is being given during the trial. Treatment is given over a long period, with regular study visits while the injections continue. The purpose of the study is to understand the efficacy and safety of KAI-9531 in people living with obesity or overweight and diabetes.

During the study, body weight, blood sugar, and other health measures are checked over time. The study also looks at possible side effects and at whether the body makes antibodies, which are proteins the immune system can form against a medicine. This information helps show how the treatment works and how safe it is for people taking it.

1 study treatment begins

after joining the study, you start receiving kai-9531 or placebo. the study is randomized, which means the treatment is assigned by chance.

the study is double-blind, which means that you and the study staff do not know whether you are receiving kai-9531 or placebo.

kai-9531 is given as a subcutaneous injection, which means an injection under the skin.

the medicine is given once weekly, meaning one time every week.

the planned study dose for kai-9531 is listed as 00 mg. the source data do not provide a usable active dose amount.

2 weekly treatment period

you continue with the assigned injection once weekly during the treatment period.

the treatment period lasts until the end of the study follow-up described in the trial. the source data do not list the full visit schedule or the number of injections.

the study compares kai-9531 with placebo, which is an inactive solution that looks the same as the study medicine but does not contain the active drug.

3 study measurements during treatment

during the study, your body weight is measured. the main goal is to look at the percent change in body weight from the start of the study to week 76.

your hemoglobin a1c (hba1c) is checked. hba1c is a blood test that shows average blood sugar over the past few months.

other measurements may include waist size, absolute weight, fasting blood glucose (blood sugar after not eating), blood pressure, and blood fats such as triglycerides, hdl-cholesterol, non-hdl-cholesterol, total cholesterol, ldl-cholesterol, and vldl-cholesterol.

other study checks may include insulin levels, questions about eating behavior, and questions about how food thoughts affect you.

the study may also check for treatment-emergent adverse events, which means new or worsening medical problems that appear after treatment starts.

blood tests may also look for antidrug antibodies and neutralizing antibodies, which are immune proteins that can react against the study medicine.

the amount of kai-9531 in your body may also be measured.

4 week 76 assessment

the main results are assessed at week 76.

the study checks whether your body weight has changed and whether your hba1c has changed from the start of the study.

the study may also look at whether your weight has gone down by at least 5%, 10%, 15%, 20%, or 25%.

additional comparisons may include changes in waist size, bmi (body mass index, a number based on height and weight), blood sugar, blood pressure, blood fats, and questionnaire results.

5 end of study period

the planned study period ends by the stated study end date.

the source data do not provide any further trial stages after the week 76 assessments and do not list any additional steps.

Who Can Join the Study?

Have a diagnosis of type 2 diabetes mellitus (T2DM), which means diabetes that the body does not manage well because it does not use insulin properly.
Have been on stable treatment for type 2 diabetes for at least 3 months before screening. Stable treatment means the diabetes treatment has not been changed during that time.
The stable diabetes treatment may be diet and exercise only, or a medicine taken by mouth for diabetes, but it must not include any of the following medicines: GLP-1 receptor agonists (medicines that help lower blood sugar and may reduce appetite), GLP-1/GIP dual agonists (medicines that act on two hormone targets to help control blood sugar and weight), or DPP-4 inhibitors (medicines that help the body release more insulin after meals).
Have a body mass index (BMI) of at least 27 kg/m². BMI is a number based on height and weight that helps estimate body fat.
Have a history of at least one unsuccessful attempt to lose weight using diet and exercise within the past 6 months.

Who Cannot Join the Study?

Current type 1 diabetes or any other type of diabetes other than type 2 diabetes.
A past suicide attempt.
Active or unstable major depressive disorder (a serious long-term depression) or another severe mental health disorder, such as schizophrenia (a condition that affects thinking and perception), bipolar disorder (a condition with extreme mood changes), or another serious mood or anxiety disorder, within the past 2 years.
Use of semaglutide, tirzepatide, GLP-1 receptor agonists (medicines that act like a gut hormone to lower blood sugar and often reduce appetite), GLP-1/GIP agonists (medicines that act on two gut hormone pathways), glucagon receptor agonists (medicines that affect blood sugar control), or other weight-loss medicines or treatments besides diet and exercise within the past 3 months.
A history of diabetic ketoacidosis (a dangerous buildup of acids in the blood) or hyperosmolar state/coma (a severe diabetes emergency with very high blood sugar and possible loss of consciousness) within the past 1 year.
A history of severe hypoglycemia (dangerously low blood sugar) or hypoglycemia unawareness (not noticing low blood sugar symptoms) within the past 1 year.
Starting medicines within the past 3 months that may cause significant weight gain, including tricyclic antidepressants (older antidepressants), atypical antipsychotics (medicines used for certain mental health conditions), and mood stabilizers (medicines that help control mood changes).
Unstable weight, meaning body weight changed by more than 5% in the past 3 months.
Personal or family history of multiple endocrine neoplasia type 2 (a rare inherited condition that causes hormone gland tumors) or medullary thyroid cancer (a type of thyroid cancer).
Uncontrolled hypertension (high blood pressure that is not well managed) or unstable cardiovascular disease (heart or blood vessel disease that is not stable).
History of pancreatitis, which is inflammation of the pancreas, either in the past or currently.
Known important problems with stomach emptying, such as severe gastroparesis (very slow stomach emptying), gastric outlet obstruction (a blockage that keeps food from leaving the stomach), or inflammatory bowel disease or irritable bowel syndrome if these are clinically significant, or long-term use of medicines that directly affect bowel movement for more than 30 days in a row within the past 3 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Diahaza s.r.o.	Zlin	Czechia
Ctc Hodonín s.r.o.	Hodonin	Czechia
Diab Serwis Popenda Sp. j.	Chorzow	Poland
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD	Pleven	Bulgaria
Klinisches Forschungszentrum Dr. Hagemann Hausarztzentrum am Germaniaplatz	Essen	Germany

Other Sites

Site Name	City	Country
ResTrial s.r.o.	Prague	Czechia
PreventaMed s.r.o.	Olomouc	Czechia
Medizentrum Essen Borbeck	Essen	Germany
Kardiologicka ambulance MUDr. Ferkl s.r.o.	Horni Predmesti	Czechia
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH	Oldenburg In Holstein	Germany
Hospital Virgen De Las Montanas	Villamartin	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital General Universitario De Valencia	Valencia	Spain
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
University Of Debrecen	Debrecen	Hungary
Clinexpert Kft.	Budapest	Hungary
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Pratia S.A.	Skorzewo	Poland
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Lukmed 2 Sp. z o.o.	Siedlce	Poland
Borbanya Praxis Egeszsegugyi Kft.	Nyiregyhaza	Hungary
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
DRC Kft.	Balatonfured	Hungary
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Medical Center Teodora EOOD	Ruse	Bulgaria
Diamedical Medical Center 2013 Ltd.	Dimitrovgrad	Bulgaria
Fakultni Thomayerova nemocnice	Prague	Czechia
Medical Plus s.r.o.	Uherske Hradiste	Czechia
Medicus Services s.r.o.	Brandys Nad Labem	Czechia
University Of Szeged	Szeged	Hungary
Instituto Gallego de Cirugía Ocular	Ferrol	Spain
Diahelp s.r.o.	Pardubice	Czechia
Velocity Nova sp. z o.o.	Skierniewice	Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski	Poznan	Poland
Zdrowie Osteo-Medic	Bialystok	Poland
Klinische Forschung Schwerin GmbH	Schwerin	Germany
Borvo Clinic Kft.	Debrecen	Hungary
Uee Krklimdta Fjrtgmnmb	Essen	Germany
Ibnxwhu a dxfdgeijjxeivu ohhnyile sgtwwk	Nachod	Czechia
dhrnubpampbrawxrbpgyi &ahafad Cpsqfi fyh Cgrzyxap Sizvofi Dwc Lqvqmrakh	Falkensee	Germany
Fjthlbya neipvzond Mhidn a Hyaybbt	Prague	Czechia
Mzvimegwc Iwrnjfrjto Cgfavueo Srukqdwo Soo z omfo	Warsaw	Poland
Eobyln Stz z obno	Lublin	Poland
Ljrviij Kqvw	Baja	Hungary
Ekrkrarsuux Ckjokd Oxk	Sofia	Bulgaria
Pzhqepasf 2zbj Mkldi	Stara Zagora	Bulgaria
Myjjtyv Chewhi Dtd Mklttnep Efxa	Kyustendil	Bulgaria
Zrukiew fjl kttregqwe Fiovlcgjb	Cologne	Germany
Hlgpnilj Vuek dofpfzrc	Barcelona	Spain
Dintgimcid Cakcxkwfckxk Cwaewf Eeihze Owx	Varna	Bulgaria
Sjnrg Mvojkz Rzonnxxzlqfojq Ntufwlmhq Kylz	Budapest	Hungary

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	25.06.2026
Czechia	Not yet recruiting	25.06.2026
Germany	Not yet recruiting	25.06.2026
Hungary	Not yet recruiting	25.06.2026
Poland	Not yet recruiting	25.06.2026
Spain	Not yet recruiting	25.06.2026

Trial locations

Investigated drugs:

HRS 9531

KAI-9531 is the study medicine being tested in this trial. It is given as a shot under the skin once a week. The trial is checking whether it can help people with obesity or overweight and diabetes lose weight and improve blood sugar control compared with placebo.

Investigated diseases:

Obesity

Obesity – Obesity is a condition in which excess body fat builds up to a level that is above healthy for a person’s height. It usually develops gradually when body energy intake stays higher than energy use over time. As it progresses, body weight increases and fat may collect around the waist and other parts of the body. It can also be associated with changes in blood sugar, blood fats, and blood pressure.

Trial ID:

2025-523510-87-00

Protocol code:

K9531-3104

NCT ID:

NCT07284901

Trial Phase:

Therapeutic confirmatory (Phase III)

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KAI-9531 in Adults With Obesity or Overweight and Diabetes

What is this study about?

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