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 <b>study treatment begins</b>

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 <b>weekly treatment period</b>

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 <b>study measurements during treatment</b>

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 <b>week 76 assessment</b>

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 <b>end of study period</b>

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 Status
University Of Debrecen Debrecen Hungary
Hospital Vall d’Hebron Barcelona Spain
Virgen del Rocío University Hospital Sevilla Spain
Fakultni nemocnice Motol a Homolka Prague Czechia
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital General Universitario De Valencia Valencia Spain
University Of Szeged Szeged Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Fakultni Thomayerova nemocnice Prague Czechia
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Medical Plus s.r.o. Uherske Hradiste Czechia
Medizentrum Essen Borbeck Essen Germany
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Futuremeds Sp. z o.o. Wroclaw Poland
Medical Center Berbatov Ltd. Yambol Bulgaria
Medical Center Akad. Iv. Penchev EOOD Sofia Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria

Other Sites

Site Name City Country Status
Clinexpert Kft. Budapest Hungary
Medicus Services s.r.o. Brandys Nad Labem Czechia
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD Pleven Bulgaria
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Pratia S.A. Skorzewo Poland
Ctc Hodonín s.r.o. Hodonin Czechia
Medical Center Teodora EOOD Ruse Bulgaria
Diab Serwis Popenda Sp. j. Chorzow Poland
Hospital Virgen De Las Montanas Villamartin Spain
Diahaza s.r.o. Zlin Czechia
Klinische Forschung Schwerin GmbH Schwerin Germany
Borvo Clinic Kft. Debrecen Hungary
Klinisches Forschungszentrum Dr. Hagemann Essen Germany
Clinicly Sp. z o.o. Opole Poland
Mjpzlvdnm Iweuokttnm Cfxigsgx Smwenuqy Szi z oaeo Warsaw Poland
Msiffll Czllsn Hruq Endl Sofia Bulgaria
Ewm Nhlnslbrwlgk Sgm z oihc Warsaw Poland
Eggzfdllwtv Cfhakw Odq Sofia Bulgaria
Eprhxi Six z owth Lublin Poland
Pmfbsiskw 2tbl Mjsao Stara Zagora Bulgaria
Rasqkjci swcalt Prague Czechia
Mhrzxri Cqyivx Duw Mffgjovz Elmg Kyustendil Bulgaria
dscoybihkxzbsvbxkvcsw &poghvj Cyyydf fyn Coqooqer Sprdibj Dnu Llwlcfnvi Falkensee Germany
Imcavqc a dvfspdblhkmnyw opocvhoj soanzf Nachod Czechia
Slzeo Mwyhfd Riamruqkomstrm Nvuycvple Kooa Budapest Hungary
Drirsjb sauefo Pardubice Czechia
Ltqrnky Kyqd Baja Hungary
Prwtvkabvcs sjptbw Olomouc Czechia
Lyrulg 2 Shl z oxzq Siedlce Poland
Rtnala Iwhpaqno fqly mlpurfcnzvdz Syumgxs udo Fkxmyyyeaqf Gtat Oldenburg In Holstein Germany
Bfqonrjv Pwvfew Ewgowlljynvz Kyxp Nyiregyhaza Hungary
Cdkkvdf Mbdwvard Kvfthr Riwhaq Bqklwpnpkmfddh I Evj Kdygwaopel Slv ju Bydgoszcz Poland
Kyudvrnhiocbt akiskyska Mmrep Fqjfq snddir Horni Predmesti Czechia
Dmf Kfdu Balatonfured Hungary
Ckerljc Mpmsiswm Aalqsan Bavpljs Kvbgznysj Cracow Poland
Dzmhvoxoab Mcaptun Cltapb 2chb Lpsh Dimitrovgrad Bulgaria
Uwn Knjjiiymt Ffbcodoyw Essen Germany
Zybgddf fay kcnqsyplc Fxlgtblsc Cologne Germany
Iqvdnywmf Gskcvuo dn Cnbxqiw Oxvjhk Ferrol Spain
Vfwwkfnk Nddm sfl z oayx Skierniewice Poland
Ddydtxlkit Cbekeudipjlv Cdqptc Ectbyx Oai Varna Bulgaria
Crlhotr Ztjygop Mzdtotspxplsvc Pgyuy Becduuysp Poznan Poland
Ztqgzsv Oeymtjzqkxc Bialystok Poland
Czvgamxhnz Rdoswevu sxb z oahk Skierniewice Poland
Ckkfovk Mpiqjxhe Jmpvrcm Sld z ollw Warsaw Poland
Etw Lnfsgc Lublin Poland
Rzawxgsuqx Ppxkupxi Debtupdkfljqxcojhrunuyedlaolcecoz Sitbpqifu sguci Lialamj Wroclaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated Drugs:

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 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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