Fact CheckerSign in

NCT07284901Active, not recruitingPhase 3

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1270 (actual)
First submitted
9 Dec 2025
Start date
12 Jan 2026
Primary completion date
27 Mar 2028
Lead sponsor
Kailera
Diseases
Obesity
NCT number
NCT07284901
EU CT number
2025-523510-87-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1270
  • From 12 Jan 2026 to the primary completion date, 27 Mar 2028
  • 191 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
  • History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
  • Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine.
  • Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
  • Known clinically significant gastric emptying abnormality or chronic treatment with medications that directly affect gastrointestinal (GI) motility if taken for \>30 days continually within 3 months prior to Screening.
  • History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.

Other illness

  • Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
  • Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
  • Uncontrolled hypertension or unstable cardiovascular disease.
  • History of chronic or acute pancreatitis.
  • History of suicide attempt.

Lab values

  • 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.
    • Note: Additional inclusion/exclusion criteria may apply, per protocol.

Who the study is looking for

  • Diagnosis of type 2 diabetes mellitus (T2DM).
  • Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
  • BMI ≥27 kg/m\^2.
  • History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (191)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaUnknown status
-
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Godoy CruzArgentinaUnknown status
-
Coordinator of this site? Confirm its status
La PlataArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
San Nicolás de los ArroyosArgentinaUnknown status
-
Coordinator of this site? Confirm its status
ZárateArgentinaUnknown status
-
Coordinator of this site? Confirm its status
BlacktownAustraliaUnknown status
-
Coordinator of this site? Confirm its status
BruceAustraliaUnknown status
-
Coordinator of this site? Confirm its status
CamberwellAustraliaUnknown status
-
Coordinator of this site? Confirm its status
CharlestownAustraliaUnknown status
-
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status
-
Coordinator of this site? Confirm its status
KanwalAustraliaUnknown status
-
Coordinator of this site? Confirm its status
LeichhardtAustraliaUnknown status
-
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
-
Coordinator of this site? Confirm its status
MorayfieldAustraliaUnknown status
-
Coordinator of this site? Confirm its status
PenrithAustraliaUnknown status
-
Coordinator of this site? Confirm its status
South BrisbaneAustraliaUnknown status
-
Coordinator of this site? Confirm its status
SydneyAustraliaUnknown status
-
Coordinator of this site? Confirm its status
WollongongAustraliaUnknown status
Medical Center Hera - Kyustendil EOOD
Coordinator of this site? Confirm its status
KyustendilBulgariaActive, not recruiting
Medical Center Hera EOOD
Coordinator of this site? Confirm its status
MontanaBulgariaActive, not recruiting
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD
Coordinator of this site? Confirm its status
PlevenBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
Medical Center Rusemed EOOD
Coordinator of this site? Confirm its status
RuseBulgariaActive, not recruiting
Alexandrovska University Hospital
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Medical Center Akad. Iv. Penchev EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Endomedical Center OOD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Medical Center Hera EOOD
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Diamedical Medical Center 2013 Ltd.
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Umbal - Prof. D-R Stoyan Kirkovich AD
Coordinator of this site? Confirm its status
Stara ZagoraBulgariaActive, not recruiting
Prevencia 2000 MCDMP
Coordinator of this site? Confirm its status
Stara ZagoraBulgariaActive, not recruiting
Diagnostic Consultative Center Equita OOD
Coordinator of this site? Confirm its status
VarnaBulgariaActive, not recruiting
Medical Center Berbatov Ltd.
Coordinator of this site? Confirm its status
YambolBulgariaActive, not recruiting
MEDICUS SERVICES s.r.o.
Coordinator of this site? Confirm its status
Brandýs nad LabemCzechiaActive, not recruiting
Fakultni Nemocnice U Sv Anny V Brne
Coordinator of this site? Confirm its status
Brno-StredCzechiaActive, not recruiting
CTC Hodonin s.r.o.
Coordinator of this site? Confirm its status
HodonínCzechiaActive, not recruiting
Diahaza s.r.o.
Coordinator of this site? Confirm its status
HolešovCzechiaActive, not recruiting
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Coordinator of this site? Confirm its status
Horni PredmestiCzechiaActive, not recruiting
Interní a diabetologická ordinace s.r.o.
Coordinator of this site? Confirm its status
NáchodCzechiaActive, not recruiting
PreventaMed, s.r.o.
Coordinator of this site? Confirm its status
OlomoucCzechiaActive, not recruiting
Diahelp s.r.o.
Coordinator of this site? Confirm its status
PardubiceCzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
Coordinator of this site? Confirm its status
PragueCzechiaActive, not recruiting
Fakultni Nemocnice Motol a Homolka
Coordinator of this site? Confirm its status
PragueCzechiaActive, not recruiting
ResTrial s.r.o.
Coordinator of this site? Confirm its status
Prague 8CzechiaActive, not recruiting
MEDICAL PLUS Research, s.r.o.
Coordinator of this site? Confirm its status
Uherské HradištěCzechiaActive, not recruiting
Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz
Coordinator of this site? Confirm its status
EssenGermanyActive, not recruiting
Uhz Klinische Forschung
Coordinator of this site? Confirm its status
EssenGermanyActive, not recruiting
Medizentrum Essen Borbeck
Coordinator of this site? Confirm its status
EssenGermanyActive, not recruiting
diabetes-falkensee.de, ZKS Dr. Joerg Luedemann
Coordinator of this site? Confirm its status
FalkenseeGermanyActive, not recruiting
Zentrum für klinische Forschung Dr. med. Bastian Kirsch
Coordinator of this site? Confirm its status
KoelnGermanyActive, not recruiting
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Coordinator of this site? Confirm its status
Oldenburg in HolsteinGermanyActive, not recruiting
Klinische Forschung Schwerin GmbH
Coordinator of this site? Confirm its status
SchwerinGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
Coordinator of this site? Confirm its status
TuebingenGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital Nisa Sevilla Aljarafe
Coordinator of this site? Confirm its status
Castilleja De La CuestaSpainActive, not recruiting
Instituto Gallego de Cirugía Ocular
Coordinator of this site? Confirm its status
FerrolSpainActive, not recruiting
Futuremeds Spain S.L.
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitario Central De Asturias
Coordinator of this site? Confirm its status
OviedoSpainActive, not recruiting
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Hospital Quironsalud Infanta Luisa
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Consorcio Hospital General Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainActive, not recruiting
Hospital Virgen de las Montañas
Coordinator of this site? Confirm its status
VillamartínSpainActive, not recruiting
-
Coordinator of this site? Confirm its status
BournemouthUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
BradfordUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
GlasgowUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
HullUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
PlymouthUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
StevenageUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
TruroUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
YateUnited KingdomUnknown status
Lausmed Kft
Coordinator of this site? Confirm its status
BajaHungaryWithdrawn
DRC Kft.
Coordinator of this site? Confirm its status
BalatonfüredHungaryWithdrawn
Szent Margit Rendelointezet Nonprofit Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryWithdrawn
Clinexpert Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryWithdrawn
University of Debrecen
Coordinator of this site? Confirm its status
DebrecenHungaryWithdrawn
Borvo Clinic Kft
Coordinator of this site? Confirm its status
DebrecenHungaryWithdrawn
Obudai Egeszseguegyi Centrum Kft.
Coordinator of this site? Confirm its status
KaposvarHungaryWithdrawn
Borbanya Praxis Egeszsegugyi Kft
Coordinator of this site? Confirm its status
NyíregyházaHungaryWithdrawn
University of Szeged
Coordinator of this site? Confirm its status
SzegedHungaryWithdrawn
Zala Varmegyei Szent Rafael Korhaz
Coordinator of this site? Confirm its status
ZalaegerszegHungaryWithdrawn
-
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
GraftonNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
HastingsNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
NawtonNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
NelsonNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
New LynnNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
SilverdaleNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
TakapunaNew ZealandUnknown status
Zdrowie Osteo-Medic
Coordinator of this site? Confirm its status
BiałystokPolandActive, not recruiting
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Coordinator of this site? Confirm its status
BydgoszczPolandActive, not recruiting
Diab Serwis Popenda Sp. j.
Coordinator of this site? Confirm its status
ChorzowPolandActive, not recruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Coordinator of this site? Confirm its status
CracowPolandActive, not recruiting
Centrum Medyczne All-Med Badania Kliniczne
Coordinator of this site? Confirm its status
CracowPolandActive, not recruiting
Pratia S.A.
Coordinator of this site? Confirm its status
GdyniaPolandActive, not recruiting
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
Coordinator of this site? Confirm its status
KielcePolandActive, not recruiting
Futuremeds Sp. z o.o.
Coordinator of this site? Confirm its status
LodzPolandActive, not recruiting
ETG Lublin Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandActive, not recruiting
Velocity Nova Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandActive, not recruiting
EKAMED sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandActive, not recruiting
Clinicly Sp. z o.o.
Coordinator of this site? Confirm its status
OpolePolandActive, not recruiting
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Coordinator of this site? Confirm its status
PoznanPolandActive, not recruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.
Coordinator of this site? Confirm its status
RzeszowPolandActive, not recruiting
Lukmed 2 Sp. z o.o.
Coordinator of this site? Confirm its status
SiedlcePolandActive, not recruiting
Velocity Nova Sp. z o. o. Velocity Skierniewice
Coordinator of this site? Confirm its status
SkierniewicePolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
TorunPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Etg Warszawa Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Centrum Medyczne Justmed Sp. z o.o.
Coordinator of this site? Confirm its status
WarszawaPolandActive, not recruiting
Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga Stasinska sp.p. Lekarzy
Coordinator of this site? Confirm its status
WroclawPolandActive, not recruiting
Velocity Nova Sp. z o.o.
Coordinator of this site? Confirm its status
ZamośćPolandActive, not recruiting
-
Coordinator of this site? Confirm its status
BayamónPuerto RicoUnknown status
-
Coordinator of this site? Confirm its status
BayamónPuerto RicoUnknown status
-
Coordinator of this site? Confirm its status
PoncePuerto RicoUnknown status
-
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
-
Coordinator of this site? Confirm its status
Vega BajaPuerto RicoUnknown status
-
Coordinator of this site? Confirm its status
AlbanyUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AmarilloUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AnnapolisUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BradentonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
BrownsvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ChattanoogaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ChickashaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
CullmanUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
DeSotoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
East GreenwichUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
El PasoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
EscondidoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Farmers BranchUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Farmington HillsUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
GreensboroUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
HollywoodUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
JupiterUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
KingwoodUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
La MesaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
LaureltonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
LilburnUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
LincolnUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ManassasUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MariettaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MissoulaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MonroeUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MontclairUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Morehead CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Morehead CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MorrisvilleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
NewtonUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
NorthridgeUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
OceansideUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Orange CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PlanoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Pleasant ViewUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
RichmondUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
RiverdaleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
ShreveportUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SkokieUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SpartanburgUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
StamfordUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Sun CityUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
The VillagesUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Toluca LakeUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
TomballUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.