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 | Type 2 diabetes

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 | Type 2 diabetes
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
23-01-2026
First CTIS Authorization Date
04-05-2026

Trial design

Randomised, active: kai-9531 (solution for injection) administered subcutaneously once weekly (maintenance dosing schedule described; specific mg doses not provided). comparator: placebo ("identical to kai-9531 solution for injection without active drug") administered subcutaneously once weekly.-controlled Phase III trial in Czechia, Germany, Hungary and others.

Randomised
Yes
Comparator
Active: KAI-9531 (solution for injection) administered subcutaneously once weekly (maintenance dosing schedule described; specific mg doses not provided). Comparator: Placebo ("Identical to kai-9531 solution for injection without active drug") administered subcutaneously once weekly.
Target Sample Size
1074
Trial Duration For Participant
532

Eligibility

Recruits 1074 Vulnerable population selected (isVulnerablePopulationSelected = true). No specific details on consent/assent handling for vulnerable participants are provided in the available CTIS data/documents..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). No specific details on consent/assent handling for vulnerable participants are provided in the available CTIS data/documents.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of T2DM"}
  • {"criterion_text":"- Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucosedependent insulinotropic polypeptide receptor (GIPR) dual agonist, or DPP-4 inhibitors"}
  • {"criterion_text":"- BMI ≥27 kg/m2"}
  • {"criterion_text":"- 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 T1DM or any other type of diabetes except T2DM."}
  • {"criterion_text":"- History of suicide attempt."}
  • {"criterion_text":"- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within 2 years prior to Screening."}
  • {"criterion_text":"- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP‑1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening."}
  • {"criterion_text":"- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening."}
  • {"criterion_text":"- History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening."}
  • {"criterion_text":"- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer."}
  • {"criterion_text":"- Uncontrolled hypertension or unstable cardiovascular disease"}
  • {"criterion_text":"- History of chronic or acute pancreatitis."}
  • {"criterion_text":"- Known clinically significant gastric emptying abnormality (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility if taken for >30 days continually within 3 months prior to Screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change in body weight (kg) from baseline at Week 76","definition_or_measurement_approach":"Percent change from baseline measured at Week 76"}
  • {"endpoint_text":"- Change in hemoglobin A1c (%) from baseline at Week 76","definition_or_measurement_approach":"Change from baseline in HbA1c measured at Week 76"}

Secondary endpoints

  • {"endpoint_text":"- Controlled for Type I error Percent change in body weight (kg) from baseline at Week 76","definition_or_measurement_approach":"Percent change from baseline measured at Week 76"}
  • {"endpoint_text":"- Controlled for Type I error Change in hemoglobin A1c (%) from baseline at Week 76","definition_or_measurement_approach":"Change from baseline in HbA1c measured at Week 76"}
  • {"endpoint_text":"- Percentage of participants with ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) • Change in waist circumference (cm) • Change in absolute weight (kg) • Percentage of participants with HbA1c <7% and ≤6.5% • Change in fasting blood glucose (mg/dL • Change in SBP (mm Hg) • Percent change in fasting: − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) • Change in IWQOL-Lite-CT physical function composite score","definition_or_measurement_approach":"Endpoints assessed versus baseline at Week 76 (as specified)"}
  • {"endpoint_text":"- Controlled for Type I error: Percent change in body weight (kg) from baseline at Week 76 in subgroup of participants with BMI ≥35 kg/m2","definition_or_measurement_approach":"Percent change from baseline at Week 76 in specified BMI ≥35 kg/m2 subgroup"}
  • {"endpoint_text":"- Not controlled for Type I error:From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight (kg).Change in BMI (kg/m2).Percentage of participants with HbA1c <5.7%.Change in DBP (mm Hg).Percent change in fasting:Total cholesterol (mg/dL)−LDL-cholesterol (mg/dL)−VLDL-cholesterol (mg/dL)−insulin (mIU/L).Change in Control of Eating Questionnaire (COEQ).Change (all KAI-9531 doses combined) in Food Noise Questionnaire (FNQ) score","definition_or_measurement_approach":"Endpoints assessed versus baseline at Week 76 (as specified)"}
  • {"endpoint_text":"- Not controlled for Type I error: • Treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":"Safety assessed by collection and reporting of TEAEs during treatment"}
  • {"endpoint_text":"- Not controlled for Type I error: • Antidrug antibodies (ADAs) • Neutralizing antibodies (NAbs)","definition_or_measurement_approach":"Immunogenicity assessed by measuring ADAs and NAbs"}
  • {"endpoint_text":"- Not controlled for Type I error: Concentrations of KAI-9531","definition_or_measurement_approach":"Pharmacokinetic concentrations measured for KAI-9531"}

Recruitment

Digital Remote Recruitment
True, Provision of an online subject portal and remote dietitian services are listed among sponsor/CRO responsibilities (IQVIA duties include "Provision of online subject portal" and "Remote Dietitian Services").
Planned Sample Size
1074
Recruitment Window Months
22
Consent Approach
Informed consent obtained via country-specific main ICF documents; subject information and ICFs available in multiple country-language versions (documents present for Czech, German, Spanish, Polish, Hungarian and other local-language ICFs). Pregnancy-specific ICFs are available. Consent provided by participating adults; no explicit assent process for minors is described in the available documents.

Methods

  • Patient-facing recruitment materials: participant brochures, flyers, posters (country-specific versions listed for Czechia, Germany, Spain, Poland)
  • Doctor-to-participant / Physician referral letters (country-specific)
  • Pre-enrolment information cards and pre-screener materials (country-specific)
  • Provision of online subject portal and remote dietitian services (noted as sponsor/CRO-provided services)
  • Use of study hub and other participant-facing guides and video storyboards (materials listed in documentation)

Geography

Total Number Of Sites
54
Total Number Of Participants
486

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
12
Number Of Participants
79

Sites

Site Name
Diahaza s.r.o.
Contact Person Name
Jitka Hasalova Zapletalova
Contact Person Email
j.hasalova@email.cz
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
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
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Contact Person Name
Richard Ferkl
Contact Person Email
ferklr@seznam.cz
Site Name
CTC Hodonin s.r.o.
Contact Person Name
Jiri Matuska
Contact Person Email
jiri.matuska@matmed.cz
Site Name
Diahelp s.r.o.
Contact Person Name
Juraj Divinec
Contact Person Email
divinec@diahelp-pardubice.cz
Site Name
Medicus Services s.r.o.
Contact Person Name
Jiri Krupicka
Contact Person Email
jikru@volny.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
II. interni klinika
Contact Person Name
Robert Prosecky
Contact Person Email
robert.prosecky@fnusa.cz
Site Name
Interni a diabetologicka ordinace s.r.o.
Contact Person Name
Petra Sejvlova
Contact Person Email
petra.horanska@seznam.cz
Site Name
MEDICAL PLUS Research s.r.o.
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
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

Germany

Earliest CTIS Part Ii Submission Date
22-04-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
12
Number Of Sites
8
Number Of Participants
37

Sites

Site Name
Zentrum für klinische Forschung Dr. med. Bastian Kirsch
Contact Person Name
Bastian Kirsch
Site Name
Medizentrum Essen Borbeck
Department Name
Medizentrum Essen Borbeck
Contact Person Name
Axel Schaefer
Contact Person Email
axel.schaefer@mzeb.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin IV Diabetologie, Endokrinologie
Contact Person Name
Andreas Birkenfeld
Contact Person Email
zks-pm@med.uni-tuebingen.de
Site Name
Klinische Forschung Schwerin GmbH
Contact Person Name
Charlotte von Engelhardt
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
Site Name
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz
Contact Person Name
Dirk Hagemann
Contact Person Email
dr.dirk.hagemann@web.de
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
Joeg Luedemann
Contact Person Email
jl.zks@diabetes-falkensee.de

Hungary

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
50
Number Of Sites
10
Number Of Participants
80

Sites

Site Name
Borbanya Praxis Egeszsegugyi Kft.
Department Name
-
Contact Person Name
Szilard Vasas
Contact Person Email
szilard.vasas@gmail.com
Site Name
DRC Kft.
Department Name
-
Contact Person Name
Jozsef Pauer
Contact Person Email
jozsef.pauer@drc.hu
Site Name
Szent Margit Rendelointezet Nonprofit Kft.
Department Name
Diabetologiai ambulancia
Contact Person Name
Timea Tanczer
Contact Person Email
tanczer.timea@gmail.com
Site Name
Clinexpert Kft.
Department Name
-
Contact Person Name
Istvan Pall
Contact Person Email
pall_istvan@yahoo.com
Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika
Contact Person Name
Denes Pall
Contact Person Email
pall.denes@unideb.hu
Site Name
University Of Szeged
Department Name
Belgyógyászati Klinika Nyugati Telephely
Contact Person Name
Robert Takacs
Contact Person Email
takacs.robert@med.u-szeged.hu
Site Name
Borvo Clinic Kft.
Department Name
-
Contact Person Name
Sandor Vangel
Contact Person Email
sandor.vangel@gmail.com
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
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Belgyogyaszat
Contact Person Name
Zoltan Bujtor
Contact Person Email
bujtorz@freemail.hu

Spain

Earliest CTIS Part Ii Submission Date
16-03-2026
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
53
Number Of Sites
10
Number Of Participants
105

Sites

Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Endocrinology
Contact Person Name
Cristobal Morales Portill
Contact Person Email
cr.morales@hotmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Endocrinology & Nutrition
Contact Person Name
Elias Delgado Álvarez
Contact Person Email
eliasdelga@gmail.com
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Endocrinology & Nutrition
Contact Person Name
Carlos Sanchez Juan
Contact Person Email
carlos.sanchez@uv.es
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
University Hospital Virgen Del Rocio S.L.
Department Name
Endocrinology
Contact Person Name
Pedro Pablo García Luna
Contact Person Email
garcialunapp@yahoo.es
Site Name
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Department Name
Endocrinology
Contact Person Name
Alberto Aliaga Verdugo
Contact Person Email
aliaga.verdugo@gmail.com
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Endocrinology
Contact Person Name
Margarita Rivas Fernandez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Endocrinology
Contact Person Name
Andrea Cuidin
Contact Person Email
andreea.ciudin@vallhebron.cat
Site Name
Futuremeds Spain S.L.
Department Name
Internal Medicine
Contact Person Name
Ana María 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

Poland

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
29
Number Of Sites
14
Number Of Participants
185

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Torun)
Department Name
MICS Centrum Medyczne Toruń
Contact Person Name
Anna Ocicka-Kozakiewicz
Site Name
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Contact Person Name
Katarzyna Pałka
Contact Person Email
palka.trials@gmail.com
Site Name
Zdrowie Osteo-Medic
Contact Person Name
Katarzyna Wasilewska
Contact Person Email
osteo_medic_bial@op.pl
Site Name
Diab Serwis Popenda Sp. j.
Contact Person Name
Grażyna Popenda
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name
Grażyna Pulka
Contact Person Email
pulkaallmed@gmail.com
Site Name
Ekamed Sp. z o.o.
Department Name
Centrum Medyczne Ekamed
Contact Person Name
Ewa Skokowska
Contact Person Email
ewa.skokowska@ekamed.pl
Site Name
Velocity Nova Sp. z o. o. Velocity Skierniewice
Contact Person Name
Maciej Kania
Contact Person Email
mkania@velocityclinical.com
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Gdynia
Contact Person Name
Agata Leksycka
Contact Person Email
aleksycka@pratia.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Warsaw)
Department Name
MICS Centrum Medyczne Warszawa, Chłodna
Contact Person Name
Magdalena Szuflińska-Sidorowicz
Site Name
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Contact Person Name
Paweł Bogdański
Contact Person Email
pawelbogdanski73@gmail.com
Site Name
Etg Warszawa Sp. z o.o.
Contact Person Name
Agnieszka Tiuryn-Petrulewicz
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Department Name
NZOZ Centrum Medyczne KERmed
Contact Person Name
Tomasz Ługowski
Contact Person Email
tomasz.lugowski@gmail.com
Site Name
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
Contact Person Name
Monika Piwowar
Contact Person Email
monika.diabetes@gmail.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

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
Operational and clinical trial services including remote dietitian services, provision of online subject portal, cardiac services (roles listed in sponsor duties)
Name
Icon Clinical Research Limited
Name
Pratia S.A. / Klinische Research partners (local CROs listed among third parties)

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":"Llx Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Remote Dietitian Services, Provision of online subject portal, Cardiac services (plus additional duties indicated by codes)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Dual Energy X-ray Absorptiometry (DXA) central reading","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Baim Institute For Clinical Research Inc.","duties_or_roles":"Safety adjudication","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Samples long term storage","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Concierge Service – Patient transportation - Reimbursement of patient expense","organisation_type":"Non-Pharmaceutical company"}

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
Authorisation Status
Investigational (not authorised in the population involved)
Frequency
Once weekly
Investigational Product Name
Identical to kai-9531 solution for injection without active drug
Modality
Other

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