Study of KAI-9531 in Adults With Obesity or Overweight and Weight-Related Health Problems Without Diabetes

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What is this study about?

This study is being done in people with obesity or overweight who also have other health problems linked to body weight and who do not have diabetes. The treatment being studied is KAI-9531, given as a subcutaneous injection under the skin once a week. Some people in the study will receive a placebo.

The purpose of the study is to see how well KAI-9531 works and how safe it is. Participants are assigned by chance to receive either KAI-9531 or placebo, and neither the participants nor the study team know which treatment is being given during the study. The study continues for a long period while regular injections are given and health is followed over time.

During the study, body weight and other health measures are checked at planned visits. The study looks at changes in weight, waist size, blood pressure, blood fats such as triglycerides and cholesterol, blood sugar, and quality of life related to physical function. Safety is also monitored through medical checks, blood tests, heart tracing with ECG, and review of any side effects.

Who Can Join the Study?

  • Body mass index (BMI) must be 30 kg/m² or higher, or 27 kg/m² or higher if the person has had at least one of these conditions before: high blood pressure (hypertension), abnormal blood fats (dyslipidemia), obstructive sleep apnea (a condition where breathing repeatedly stops during sleep), or heart and blood vessel disease (cardiovascular disease).
  • The person must have had at least one unsuccessful attempt to lose weight using diet and exercise within the past 6 months.

Who Cannot Join the Study?

  • A current diagnosis of diabetes mellitus or a past history of diabetes. Diabetes mellitus is a condition where blood sugar is too high.
  • Use of semaglutide, tirzepatide, a GLP-1 receptor agonist, a GLP-1/GIP medicine, or a glucagon receptor agonist within 3 months before screening. These are medicines that affect blood sugar and weight.
  • Starting any medicine within 3 months before screening that may cause major weight gain, including tricyclic antidepressants (older medicines for depression), atypical antipsychotics (medicines for some mental health conditions), or mood stabilizers (medicines that help control mood changes).
  • Unstable weight, meaning the person says their body weight changed by more than 5% in the 3 months before screening.
  • A family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid cancer. Multiple endocrine neoplasia type 2 is a rare inherited condition that can cause tumors in hormone-producing glands, and medullary thyroid cancer is a type of thyroid cancer.
  • Uncontrolled hypertension or unstable cardiovascular disease. Hypertension means high blood pressure, and cardiovascular disease means heart or blood vessel disease.
  • A history of chronic pancreatitis or acute pancreatitis. Pancreatitis is swelling and irritation of the pancreas, an organ that helps with digestion and blood sugar control.
  • A known clinically significant problem with gastric emptying, meaning the stomach does not empty food normally, or ongoing treatment with medicines that directly affect gastrointestinal motility, meaning the movement of food through the stomach and intestines.
  • A history of suicide attempt.
  • A history of significant active or unstable major depressive disorder or another severe psychiatric disorder. Major depressive disorder is a serious form of depression, and psychiatric disorder means a mental health condition.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Ctc Hodonín s.r.o. Hodonin Czechia

Other Sites

Site Name City Country Status
ResTrial s.r.o. Prague Czechia
PreventaMed s.r.o. Olomouc Czechia
Lukmed 2 Sp. z o.o. Siedlce Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Ambenet GmbH Das Ambulante Behandlungsnetz Leipzig Germany
Medizentrum Essen Borbeck Essen Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Hospital Virgen De Las Montanas Villamartin Spain
Hospital Quironsalud Barcelona Barcelona Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital General Universitario De Valencia Valencia Spain
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Debrecen Debrecen Hungary
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
KomplexLabor Kft. Kecskemet Hungary
Semmelweis University Budapest Hungary
Borbanya Praxis Egeszsegugyi Kft. Nyiregyhaza Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Medical Center Hera EOOD Sofia Bulgaria
Medical Centre Futuremeds EOOD Plovdiv Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia 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
DiaKrnov s.r.o. Krnov Czechia
Velocity Nova sp. z o.o. Skierniewice Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski Poznan Poland
Klinische Forschung Schwerin GmbH Schwerin Germany
Tonus 2013 Ltd. Pazardzhik Bulgaria
Mdchwtqnx Iuuhpomscg Cuzthfwq Satlqosd Sbc z oqyd Warsaw Poland
Kbrqrilnn Fwxobgzsx Dtqbvhs Gfqh Dresden Germany
Uip Kfpdutcwi Frfllthxt Essen Germany
Ijirvom a dgymnefbhmtmpz ojrwgqqf sticow Nachod Czechia
dqvatclwknrxsdqmdrswf &qhezqh Cezfdb fba Cazztwff Sskoecs Dcu Lbzaanwtv Falkensee Germany
Fjngtysz nlbtjidki Mkmur a Hkghpvc Prague Czechia
Lebnuah Kxaz Baja Hungary
Mfvallj Cqfgxs Beucfwok Luiq Yambol Bulgaria
Mguwnzt Cqrpix Abaql Iol Pjahcvn Eeiy Sofia Bulgaria
Mswsgih Cdvorr Dxx Mklrstfy Eous Kyustendil Bulgaria
Mvynbak Cwwdik Pisckx Cmyqet Eens Lovech Bulgaria
Zplslyl fmd kfkiqpefv Faalxhspn Cologne Germany
Hmbmgvfa Vofs dulgqagc Barcelona Spain
Pfulsn Df Mlj Cruolyko Bvyjjz Hamburg Germany
Povkgmoppnbtl Dp Uzsycc Wpdkkvzf Dj Dlsihar Dcwc Ucx Pzhu Dk Jyxy Afzmui Hamburg Germany

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

Trial status

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

Trial locations

Investigated drugs:

KAI-9531 is the study medicine being tested in this trial. It is given as a subcutaneous injection, which means it is injected under the skin once a week. The goal of the study is to see whether it helps people with obesity or overweight and related health problems lose weight safely and effectively.

Identical placebo injection is a look-alike injection that does not contain any active medicine. It is used for comparison so the researchers can better tell whether KAI-9531 is working. It is given in the same way as the study medicine so neither the participants nor the study team knows who is receiving the real treatment or the placebo during the trial.

Investigated diseases:

Obesity – Obesity is a condition in which a person has too much body fat and body weight above what is considered healthy for their height. It usually develops over time when energy intake is greater than energy use. The condition can continue to progress gradually, with further increases in body weight and waist size if the imbalance persists. It may also be linked with changes in body measurements and blood fat levels over time.

Trial ID:
2025-523486-17-00
Protocol code:
K9531-3103
NCT ID:
NCT07284875
Trial Phase:
Therapeutic confirmatory (Phase III)

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