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
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD	Pleven	Bulgaria
Ctc Hodonín s.r.o.	Hodonin	Czechia
Diab Serwis Popenda Sp. j.	Chorzow	Poland
Diahaza s.r.o.	Zlin	Czechia
Klinisches Forschungszentrum Dr. Hagemann	Essen	Germany
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario De Valencia	Valencia	Spain
Clinexpert Kft.	Budapest	Hungary
Medicus Services s.r.o.	Brandys Nad Labem	Czechia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
Medical Center Teodora EOOD	Ruse	Bulgaria
Hospital Virgen De Las Montanas	Villamartin	Spain
Klinische Forschung Schwerin GmbH	Schwerin	Germany
Borvo Clinic Kft.	Debrecen	Hungary
Clinicly Sp. z o.o.	Opole	Poland
Mbrpatuoj Iayluehtlu Clabcdwc Svpynsic Szx z oyfh	Warsaw	Poland
Uiyrcbfhij Ot Dbpedzrz	Debrecen	Hungary
Mjtenkd Coguxy Hjlh Ezak	Sofia	Bulgaria
Haiekaau Vqgs dizvxlhl	Barcelona	Spain
Vzazlq dnv Rydvq Uovwuqrjpl Hlijlbsj	Sevilla	Spain
Ffcmobzv ntvarmvlp Mdkfo a Hnylzzi	Prague	Czechia
Umwafjqzekjhytsxgopca Tjkzpengu Aws	Tuebingen	Germany
Uspvewgyru Od Stckei	Szeged	Hungary
Ubwseltaeb Maezpydxfkjb Hmfmlinl Foq Athbge Tixixeouc Snhbw Gszdhx Ekl	Plovdiv	Bulgaria
Eof Ncetldewhhhm Stt z ocxf	Warsaw	Poland
Eirwbqswbqz Cxdgba Olr	Sofia	Bulgaria
Egqyyq Sbd z oxml	Lublin	Poland
Pktfzxblp 2ptk Mivdl	Stara Zagora	Bulgaria
Rtcoadzw svjemk	Prague	Czechia
Meocihr Cxxgyc Dbk Mkqjtsvt Ezof	Kyustendil	Bulgaria
dkttobtzaobsepaojmtmk &gptatx Caiixd fsr Chaultev Sdhtxsy Dta Lvotydakm	Falkensee	Germany
Iugdtec a dhmasrsyjcfwgv ogilcite svddai	Nachod	Czechia
Ooaqqp Eihtcekgkynfh Cugxjgc Kqco	Dunaújváros	Hungary
Fdnybhkz Tknbnmncayk nqxvpkctj	Prague	Czechia
Sbslu Mgbdwc Rcxlirnxaahbta Nshldnvgg Kctr	Budapest	Hungary
Duapwmw spgymt	Pardubice	Czechia
Fbspflcd Nsegylbga U Sz Ayln V Bfvy	Brno-Stred	Czechia
Pvyeri Smvg	Skorzewo	Poland
Zxdc Mrhkxt Siobh Rtceqt Klftmo	Zalaegerszeg	Hungary
Lmufuik Kchj	Baja	Hungary
Pweiucrwriy slihxr	Olomouc	Czechia
Lgnwzm 2 Set z ombm	Siedlce	Poland
Rtzjlk Igeeaexk fktj mgyffxjifqba Sqoiewk uow Fjcwgfglzti Gxoy	Oldenburg In Holstein	Germany
Bupcktpl Pbuhvs Efhjpipsucyr Kago	Nyiregyhaza	Hungary
Czjwwiy Mtztdckp Pjvruxo Mnunxanrw Cgembeyx Lehczvagjy Mhutyc Zdtupgkwe sslgh	Cracow	Poland
Mszkaiw Pnhn sdabxg	Uherske Hradiste	Czechia
Msrigolkcno Ebuyz Bdvzjel	Essen	Germany
Crbspll Mlepkmfh Ktivdt Rqbdyr Bruwiqqrtfhxbm I Exz Kosbvctgup Sjp ju	Bydgoszcz	Poland
Kojjvtljndpyg aejotjqte Meovo Fwpvr sunozi	Horni Predmesti	Czechia
Dnj Kwbc	Balatonfured	Hungary
Crskosp Mbmjikok Aoxzvso Bhuivmq Kacgjaucy	Cracow	Poland
Dbusbweweb Mxiarvj Chywww 2vqg Lmkq	Dimitrovgrad	Bulgaria
Uhh Kwdyjebbx Fdbwptukm	Essen	Germany
Zgkfewb fil kmqkjoury Feyrsgkvb	Cologne	Germany
Iqfgnrlze Gsgfcma dp Crzxqxj Otfunx	Ferrol	Spain
Vcmgddva Nmya sqv z oamg	Skierniewice	Poland
Dkmmshidsq Cdqmvgmnbdod Ccnzyw Elvtlc Oxj	Varna	Bulgaria
Cgaflzq Zldenne Mevtugghrqfilm Pcncs Bgntkmvun	Poznan	Poland
Zckjhfm Ounpqmbvdfy	Bialystok	Poland
Cxihkrchfg Rbbhtrqq str z ovmn	Skierniewice	Poland
Cdeffaw Mzfokbtr Jqdfqxr Sjm z ormn	Warsaw	Poland
Eqq Ltduoj	Lublin	Poland
Crmahjt Movaxwap Millh Sko z ouxa	Rzeszow	Poland
Roewlkmdca Piywffkk Dbpeofvvdmbzntbxkhhrswuwmewzbrspr Slmhoxeca sxcau Lnsomwy	Wroclaw	Poland

Trial status

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

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?

Who Can Join the Study?

Who Cannot Join the Study?