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NCT07284875Active, not recruitingPhase 3

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have 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 With Weight-Related Comorbidities Who Do Not Have Diabetes

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2530 (actual)
First submitted
9 Dec 2025
Start date
18 Dec 2025
Primary completion date
29 Feb 2028
Lead sponsor
Kailera
Diseases
Obesity
NCT number
NCT07284875
EU CT number
2025-523486-17-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 2530
  • From 18 Dec 2025 to the primary completion date, 29 Feb 2028
  • 117 sites in 11 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

  • 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 motility.

Other illness

  • Current diagnosis or history of diabetes mellitus.
  • 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.
  • History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.

Lab values

  • Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
    • Note: Additional inclusion/exclusion criteria may apply, per protocol.

Who the study is looking for

  • BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
    • hypertension,
    • dyslipidemia,
    • obstructive sleep apnea, or
    • cardiovascular (CV) disease.
  • 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 (117)

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

SiteCityCountrySite status
Kailera Clinical Site
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Kailera Clinical Site #1
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Buenos AiresArgentinaUnknown status
Kailera Clinical Site #2
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Kailera Clinical Site
Coordinator of this site? Confirm its status
CABAArgentinaUnknown status
Kailera Clinical Site
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CórdobaArgentinaUnknown status
Kailera Clinical Site
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Godoy CruzArgentinaUnknown status
Kailera Clinical Site
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La PlataArgentinaUnknown status
Kailera Clinical Site #1
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Kailera Clinical Site #2
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Kailera Clinical Site #3
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RosarioArgentinaUnknown status
Kailera Clinical Site #1
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San Nicolás de los ArroyosArgentinaUnknown status
Kailera Clinical Site #2
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San Nicolás de los ArroyosArgentinaUnknown status
Kailera Clinical Site
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CharlestownAustraliaUnknown status
Kailera Clinical Site
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Heidelberg HeightsAustraliaUnknown status
Kailera Clinical Site
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MelbourneAustraliaUnknown status
Kailera Clinical Site
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NorwoodAustraliaUnknown status
Kailera Clinical Site
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Sippy DownsAustraliaUnknown status
Kailera Clinical Site
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SydneyAustraliaUnknown status
Kailera Clinical Site
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WollongongAustraliaUnknown status
Medical Center Hera - Kyustendil EOOD
Coordinator of this site? Confirm its status
KyustendilBulgariaActive, not recruiting
Tonus 2013 Ltd.
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PazardzhikBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
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PlovdivBulgariaActive, not recruiting
Medical Centre Futuremeds EOOD
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PlovdivBulgariaActive, not recruiting
Alexandrovska University Hospital
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SofiaBulgariaActive, not recruiting
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaActive, not recruiting
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
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SofiaBulgariaActive, not recruiting
Medical Center Akad. Iv. Penchev EOOD
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SofiaBulgariaActive, not recruiting
Medical Center Hera EOOD
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SofiyaBulgariaActive, not recruiting
Medical Centre "Pratia Clinic" EOOD
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VarnaBulgariaActive, not recruiting
Medical Center Berbatov Ltd.
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YambolBulgariaActive, not recruiting
MEDICUS SERVICES s.r.o.
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Brandýs nad LabemCzechiaActive, not recruiting
Vojenska Nemocnice Brno
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Brno-ZideniceCzechiaActive, not recruiting
CTC Hodonin s.r.o.
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HodonínCzechiaActive, not recruiting
DiaKrnov s.r.o.
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KrnovCzechiaActive, not recruiting
Interní a diabetologická ordinace s.r.o.
Coordinator of this site? Confirm its status
NáchodCzechiaActive, not recruiting
PreventaMed, s.r.o.
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OlomoucCzechiaActive, not recruiting
Fakultni Nemocnice Motol a Homolka
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PragueCzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
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PragueCzechiaActive, not recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaActive, not recruiting
ResTrial s.r.o.
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Prague 8CzechiaActive, not recruiting
MEDICAL PLUS Research, s.r.o.
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Uherské HradištěCzechiaActive, not recruiting
Klinische Forschung Dresden GmbH
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DresdenGermanyActive, not recruiting
Uhz Klinische Forschung
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EssenGermanyActive, not recruiting
Medizentrum Essen Borbeck
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EssenGermanyActive, not recruiting
diabetes-falkensee.de, ZKS Dr. Joerg Luedemann
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FalkenseeGermanyActive, not recruiting
Praxis Dr. med. Cornelia Brauer
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HamburgGermanyActive, not recruiting
Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle
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HamburgGermanyActive, not recruiting
Zentrum für klinische Forschung Dr. med. Bastian Kirsch
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KoelnGermanyActive, not recruiting
Ambenet GmbH Das Ambulante Behandlungsnetz
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LeipzigGermanyActive, not recruiting
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyActive, not recruiting
Klinische Forschung Schwerin GmbH
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SchwerinGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Quirónsalud Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainActive, not recruiting
Instituto Gallego de Cirugía Ocular
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FerrolSpainActive, not recruiting
Futuremeds Spain S.L.
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MadridSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
Hospital Quironsalud Infanta Luisa
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SevillaSpainActive, not recruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainActive, not recruiting
Hospital Virgen de las Montañas
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VillamartínSpainActive, not recruiting
Kailera Clinical Site
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BradfordUnited KingdomUnknown status
Kailera Clinical Site
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HounslowUnited KingdomUnknown status
Kailera Clinical Site
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HullUnited KingdomUnknown status
Kailera Clinical Site
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LeicesterUnited KingdomUnknown status
Kailera Clinical Site
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LondonUnited KingdomUnknown status
Kailera Clinical Site
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ManchesterUnited KingdomUnknown status
Kailera Clinical Site
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Newcastle upon TyneUnited KingdomUnknown status
Kailera Clinical Site
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NottinghamUnited KingdomUnknown status
Kailera Clinical Site
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SohamUnited KingdomUnknown status
Kailera Clinical Site
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StevenageUnited KingdomUnknown status
Kailera Clinical Site
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TorpointUnited KingdomUnknown status
Lausmed Kft
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BajaHungaryCompleted
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
Semmelweis University
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Budapest XIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Obudai Egeszseguegyi Centrum Kft.
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KaposvarHungaryCompleted
KomplexLabor Kft.
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KecskemétHungaryCompleted
Borbanya Praxis Egeszsegugyi Kft
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NyíregyházaHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Kailera Clinical Site
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AucklandNew ZealandUnknown status
Kailera Clinical Site
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GraftonNew ZealandUnknown status
Kailera Clinical Site
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HamiltonNew ZealandUnknown status
Kailera Clinical Site
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NelsonNew ZealandUnknown status
Kailera Clinical Site
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SilverdaleNew ZealandUnknown status
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Coordinator of this site? Confirm its status
CracowPolandActive, not recruiting
Centrum Zdrowia Metabolicznego Pawel Bogdanski
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PoznanPolandActive, not recruiting
Lukmed 2 Sp. z o.o.
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SiedlcePolandActive, not recruiting
Velocity Nova Sp. z o.o.
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SkierniewicePolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandActive, not recruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandActive, not recruiting
Velocity Nova Sp. z o.o.
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ZamośćPolandActive, not recruiting
Kailera Clinical Site
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AmarilloUnited StatesUnknown status
Kailera Clinical Site
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AnnistonUnited StatesUnknown status
Kailera Clinical Site
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AuroraUnited StatesUnknown status
Kailera Clinical Site
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BellaireUnited StatesUnknown status
Kailera Clinical Site
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BirminghamUnited StatesUnknown status
Kailera Clinical Site
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BridgeportUnited StatesUnknown status
Kailera Clinical Site
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ChattanoogaUnited StatesUnknown status
Kailera Clinical Site
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ChickashaUnited StatesUnknown status
Kailera Clinical Site
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ColumbiaUnited StatesUnknown status
Kailera Clinical Site
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CullmanUnited StatesUnknown status
Kailera Clinical Site
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DanvilleUnited StatesUnknown status
Kailera Clinical Site
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DeSotoUnited StatesUnknown status
Kailera Clinical Site
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EscondidoUnited StatesUnknown status
Kailera Clinical Site
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JupiterUnited StatesUnknown status
Kailera Clinical Site
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Las VegasUnited StatesUnknown status
Kailera Clinical Site
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LilburnUnited StatesUnknown status
Kailera Clinical Site
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MauldinUnited StatesUnknown status
Kailera Clinical Site
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Morehead CityUnited StatesUnknown status
Kailera Clinical Site
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RochesterUnited StatesUnknown status
Kailera Clinical Site
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Salt Lake CityUnited StatesUnknown status
Kailera Clinical Site
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SpringfieldUnited StatesUnknown status
Kailera Clinical Site
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Sun CityUnited StatesUnknown status
Kailera Clinical Site
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Toluca LakeUnited StatesUnknown status
Kailera Clinical Site
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TomballUnited StatesUnknown status

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