Clinical trial • Phase III • Endocrinology

TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL([2-[2- AMINOETHOXY]ETHOXY]ACETYL-[2-[2-AMINOETHOXY]ETHOXY]ACETYL-GAMMA-GLUTAMYL-EICOSANOYL)-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL AMIDE for Obesity

Phase III trial of TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL([2-[2- AM…

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Obesity
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
23-01-2026
First CTIS Authorization Date
05-05-2026

Trial design

Randomised, identical to kai-9531 solution for injection without active drug (placebo); kai-9531 subcutaneous (sc) once weekly (sc qw)-controlled Phase III trial across 47 sites in Czechia, Germany, Hungary and others.

Randomised
Yes
Comparator
Identical to kai-9531 solution for injection without active drug (placebo); KAI-9531 subcutaneous (SC) once weekly (SC QW)
Target Sample Size
1188
Trial Duration For Participant
532

Eligibility

Recruits 1188 adults.

Inclusion criteria

  • {"criterion_text":"- BMI ≥30 kg/m², or BMI ≥27 kg/m² with a prior diagnosis of at least one of the following: Hypertension Dyslipidemia Obstructive sleep apnea Cardiovascular disease\n- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months."}

Exclusion criteria

  • {"criterion_text":"- Current diagnosis or history of diabetes mellitus\n- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months prior to Screening.\n- Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.\n- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.\n- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.\n- Uncontrolled hypertension or unstable cardiovascular disease\n- History of chronic or acute pancreatitis\n- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect GI motility.\n- History of suicide attempt.\n- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change in body weight (kg) from baseline at Week 76","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Percent change in body weight (kg) from baseline at Week 76","definition_or_measurement_approach":""}
  • {"endpoint_text":"- From baseline at Week 76 Percentage of participants with ≥5%,≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) Change in waist circumference (cm) Change in absolute body weight (kg) Change (all KAI-9531 doses combined) in SBP (mm Hg) Percent change (all KAI-9531 doses combined) in (fasting): − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change (all KAI-9531 doses combined) in IWQOL-Lite-CT physical function composite score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percent change in body weight (kg) from baseline at Week 76 in the subgroup of participants with BMI ≥35 kg/m2","definition_or_measurement_approach":""}
  • {"endpoint_text":"- From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight(kg).Change in BMI(kg/m2).Change(all KAI-9531 doses combined) in DBP (mm Hg).Percent change(all KAI-9531 doses combined) in(fasting):−Total cholesterol(mg/dL)−LDL-cholesterol(mg/dL)−VLDL-cholesterol(mg/dL). Percent change(all KAI-9531 doses combined) in fasting insulin (mIU/L).Change(all KAI-9531 doses combined) in fasting blood glucose (mg/dL).Change(all KAI-9531 doses combined) in COEQ","definition_or_measurement_approach":""}
  • {"endpoint_text":"- TEAEs, clinical laboratory parameters, ECGs, and vital sign","definition_or_measurement_approach":""}
  • {"endpoint_text":"- ADA NAb","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Population PK Efficacy, safety, and tolerability exposure-response analysis","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
True — documents and third-party duties reference provision of an online subject portal (IQVIA), eCOA/electronic documents, Study Hub, video storyboards, and remote dietitian services to support participants remotely.
Planned Sample Size
1188
Recruitment Window Months
21
Consent Approach
Informed consent obtained from participants using country-specific ICFs; subject information and informed consent forms are provided (examples in documents: Czech (cs), German (DEU), Spanish (ESP), Hungarian (HUN), Polish (PL)). Versions include Main ICF, GDPR ICF, Optional Procedure ICF, Pregnancy Follow-up ICF. Consent is provided by the participant; no assent/minor consent process is described in the available documents.

Methods

  • Patient advertisement materials (flyers, posters, participant brochures) — country-specific materials listed in recruitment documents (examples: DEU, ES P, CZE, HUN, PL).
  • Doctor-to-Participant Letter / Physician Referral Letter — materials provided to physicians to refer potential participants (country-specific versions documented).
  • Pre-enrolment information cards and Participant ID cards — printed pre-enrolment materials available (country-specific).
  • Employer Letter and outreach via clinical/research centres — documented in participant-facing materials.
  • Study Hub / online subject portal and eCOA/video materials — digital resources for participants (referenced in documents and sponsor/CRO responsibilities).

Geography

Total Number Of Sites
47
Total Number Of Participants
453

Czechia

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
66
Number Of Sites
11
Number Of Participants
115

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Centrum kardiovaskularni prevence 1. LF UK a FTN
Contact Person Name
Renata Cifkova
Contact Person Email
renata.cifkova@ftn.cz
Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Ustav lekarske chemie a klinicke biochemie 2. LF UK a FN Motol
Contact Person Name
Jana Cepova
Contact Person Email
jana.cepova@fnmotol.cz
Site Name
MEDICAL PLUS Research s.r.o.
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
Medicus Services s.r.o.
Contact Person Name
Jiri Krupicka
Contact Person Email
jikru@volny.cz
Site Name
Interni a diabetologicka ordinace s.r.o.
Contact Person Name
Petra Sejvlova
Contact Person Email
petra.horanska@seznam.cz
Site Name
CTC Hodonin s.r.o.
Contact Person Name
Jiri Matuska
Contact Person Email
jiri.matuska@matmed.cz
Site Name
ResTrial s.r.o.
Contact Person Name
Emilia Malicherova
Site Name
PreventaMed s.r.o.
Contact Person Name
Jiri Pumprla
Contact Person Email
research@vilazdravi.cz
Site Name
Vojenska Nemocnice Brno
Department Name
Interni oddeleni – Kardiologie
Contact Person Name
Roman Miklik
Contact Person Email
romanmiklik@yahoo.com
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
III.interni klinika-klinika endokrinologie a metabolismu
Contact Person Name
Martin Prazny
Contact Person Email
martin.prazny@outlook.com
Site Name
DiaKrnov s.r.o.
Contact Person Name
Tomas Edelsberger
Contact Person Email
edelsberger@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
25
Number Of Sites
11
Number Of Participants
79

Sites

Site Name
Medizentrum Essen Borbeck
Contact Person Name
Axel Schaefer
Contact Person Email
axel.schaefer@mzeb.de
Site Name
Klinische Forschung Dresden GmbH
Contact Person Name
Peter Heymer
Contact Person Email
peter.heymer@pratia.com
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
ds@ambenet.de
Site Name
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
Contact Person Name
Dominik Dahl
Contact Person Email
dr.dahl@dzhw.de
Site Name
Klinische Forschung Schwerin GmbH
Contact Person Name
Charlotte von Engelhardt
Site Name
Uhz Klinische Forschung
Department Name
Unterfrintroper Hausartztzentrum / UHZ Klinishe Forschung
Contact Person Name
Georg Plassmann
Contact Person Email
georg-plassmann@uhz-klifo.de
Site Name
diabetes-falkensee.de, ZKS Dr. Joerg Luedemann
Department Name
Diabetes and Foot Care Center DDG and Center for Clinical Studies Dr. med Joerg Luedemann
Contact Person Name
Joerg Luedemann
Contact Person Email
jl.zks@diabetes-falkensee.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin IV Diabetologie, Endokrinologie, Nephrologie
Contact Person Name
Andreas Birkenfeld
Site Name
Praxis Dr Med Cornelia Brauer
Contact Person Name
Cornelia Brauer
Contact Person Email
cschiewe@web.de
Site Name
Zentrum für klinische Forschung Dr. med. Bastian Kirsch
Contact Person Name
Bastian Kirsch
Site Name
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Department Name
Geschaeftsfuehrung
Contact Person Name
Thomas Schaum
Contact Person Email
Schaum@red-institut.de

Hungary

Earliest CTIS Part Ii Submission Date
18-03-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
58
Number Of Sites
9
Number Of Participants
69

Sites

Site Name
Borbanya Praxis Egeszsegugyi Kft.
Department Name
-
Contact Person Name
Szilard Vasas
Contact Person Email
szilard.vasas@gmail.com
Site Name
Semmelweis University
Department Name
Varosmajori Sziv- és Ergyogyaszati Klinika
Contact Person Name
Bela Merkely
Contact Person Email
merkely.bela@semmelweis.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Department Name
-
Contact Person Name
Timea Balo
Contact Person Email
timea.balo@oec.hu
Site Name
KomplexLabor Kft.
Department Name
-
Contact Person Name
Istvan Szabo
Contact Person Email
szaboii2016@gmail.com
Site Name
University Of Debrecen
Department Name
Belgyogyaszati Klinika
Contact Person Name
Denes Pall
Contact Person Email
pall.denes@unideb.hu
Site Name
Semmelweis University
Department Name
Belgyógyászati és Onkológiai Klinika
Contact Person Name
Istvan Takacs
Contact Person Email
takacs.istvan@semmelweis.hu
Site Name
University Of Szeged
Department Name
Belgyógyászati Klinika Nyugati Telephely
Contact Person Name
Robert Takács
Contact Person Email
takacs.robert@med.u-szeged.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Department Name
-
Contact Person Name
Andrea Varkonyi
Contact Person Email
andrea.varkonyi@oec.hu
Site Name
Lausmed Kft.
Department Name
-
Contact Person Name
Laszlo Konyves
Contact Person Email
dr.konyves@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
22
Number Of Sites
9
Number Of Participants
84

Sites

Site Name
Futuremeds Spain S.L.
Department Name
Internal Medicine
Contact Person Name
Ana Maria Moreno Collado
Contact Person Email
ana.moreno@futuremeds.com
Site Name
Instituto Gallego de Cirugía Ocular
Department Name
Endocrinology
Contact Person Name
Alma Maria Prieto Tenreiro
Contact Person Email
almaprietotenreiro@gmail.com
Site Name
Hospital Virgen De Las Montanas
Department Name
Internal Medicine
Contact Person Name
Enrique Garcia del Rio
Contact Person Email
silen@comcadiz.es
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Endocrinology
Contact Person Name
Carlos Sanchez Juan
Contact Person Email
carlos.sanchez@uv.es
Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Endocrinology
Contact Person Name
Cristobal Morales Portillo
Contact Person Email
cr.morales@hotmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Endocrinology
Contact Person Name
Elias Delgado Alvarez
Contact Person Email
eliasdelga@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Endocrinology
Contact Person Name
Andreea Ciudin
Contact Person Email
andreea.ciudin@vallhebron.cat
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Endocrinology
Contact Person Name
Margarita Rivas Fernández
Site Name
Hospital Quironsalud Barcelona
Department Name
Internal Medicine
Contact Person Name
Amparo Carrasco Mas
Contact Person Email
amparocarrasco6@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
17-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
24
Number Of Sites
7
Number Of Participants
106

Sites

Site Name
Velocity Nova sp. z o.o.
Department Name
Velocity Skierniewice
Contact Person Name
Maciej Kania
Contact Person Email
mkania@velocityclinical.com
Site Name
Lukmed 2 Sp. z o.o.
Department Name
ETG Siedlce
Contact Person Name
Tomasz Bocianowski
Contact Person Email
t.bocianowski@etg-network.com
Site Name
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Contact Person Name
Paweł Bogdański
Contact Person Email
pawelbogdanski73@gmail.com
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Katarzyna Pałka
Contact Person Email
palka.trials@plejady.com.pl
Site Name
Velocity Nova Sp. z o.o.
Department Name
Velocity Zamość
Contact Person Name
Wojciech Czochra
Contact Person Email
wczochra@velocityclinical.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa, Chłodna
Contact Person Name
Małgorzata Szuflińska-Sidorowicz
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Anna Ocicka-Kozakiewicz

Sponsor

Primary sponsor

Full Name
Kailera Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 4
Name
IQVIA Limited
Responsibilities
Multiple responsibilities including Remote Dietitian Services, Provision of online subject portal, Cardiac services (sponsorDuties codes: 1,12,15,2,5,8)
Name
Suvoda LLC
Responsibilities
eCOA / support (sponsorDuties code: 3)

Third parties

  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"Lost to follow-up patient search","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,12,15 (Remote Dietitian Services, Provision of online subject portal, Cardiac services), 2,5,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Llx Solutions LLC","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: 15 (Duel Energy X-ray Absorptiometry (DXA) central reading)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"sponsorDuties codes: 15 (Samples long term storage)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: 15 (Concierge Service-Patient transportation - Reimbursement of patient expense)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Baim Institute For Clinical Research Inc.","duties_or_roles":"sponsorDuties codes: 15 (Safety adjudication)","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name
KAI-9531
Active Substance
TYROSYL-2-AMINOISOBUTYRYL-GLUTAMYL-GLYCYL-THREONYL-PHENYLALANYLTHREONYL-SERYL-ASPARTATE-TYROSYL-SERYL-ISOLEUCYL-TYROSYL-LYSYL([2-[2- AMINOETHOXY]ETHOXY]ACETYL-[2-[2-AMINOETHOXY]ETHOXY]ACETYL-GAMMA-GLUTAMYL-EICOSANOYL)-GLUTAMYL-LYSYL-ISOLEUCYL-ALANYL-ALANYL-GLUTAMINE-GLUTAMYL-PHENYLALANYL-VALYL-ASPARAGINE-CHROMYL-LEUCYL-LEUCYL-ALANYL-GLYCYL-GLYCYL-PROLYL-SERYL-SERYL-GLYCYL-ALANYL-PROLYL-PROLYL-PROLYL-SERYL AMIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Authorisation Status
MIA 1626 F
Frequency
Once weekly
Investigational Product Name
Identical to kai-9531 solution for injection without active drug
Modality
Other

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