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
Sites (191)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Godoy Cruz | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | San Nicolás de los Arroyos | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Zárate | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Blacktown | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Bruce | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Camberwell | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Charlestown | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Kanwal | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Leichhardt | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Morayfield | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Penrith | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Wollongong | Australia | Unknown status |
| Medical Center Hera - Kyustendil EOOD Coordinator of this site? Confirm its status | Kyustendil | Bulgaria | Active, not recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Montana | Bulgaria | Active, not recruiting |
| Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Medical Center Rusemed EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Active, not recruiting |
| Alexandrovska University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Medical Center Akad. Iv. Penchev EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Endomedical Center OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Diamedical Medical Center 2013 Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Umbal - Prof. D-R Stoyan Kirkovich AD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Active, not recruiting |
| Prevencia 2000 MCDMP Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Active, not recruiting |
| Diagnostic Consultative Center Equita OOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Active, not recruiting |
| Medical Center Berbatov Ltd. Coordinator of this site? Confirm its status | Yambol | Bulgaria | Active, not recruiting |
| MEDICUS SERVICES s.r.o. Coordinator of this site? Confirm its status | Brandýs nad Labem | Czechia | Active, not recruiting |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Active, not recruiting |
| CTC Hodonin s.r.o. Coordinator of this site? Confirm its status | Hodonín | Czechia | Active, not recruiting |
| Diahaza s.r.o. Coordinator of this site? Confirm its status | Holešov | Czechia | Active, not recruiting |
| Kardiologicka ambulance MUDr. Ferkl s.r.o. Coordinator of this site? Confirm its status | Horni Predmesti | Czechia | Active, not recruiting |
| Interní a diabetologická ordinace s.r.o. Coordinator of this site? Confirm its status | Náchod | Czechia | Active, not recruiting |
| PreventaMed, s.r.o. Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| Diahelp s.r.o. Coordinator of this site? Confirm its status | Pardubice | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| ResTrial s.r.o. Coordinator of this site? Confirm its status | Prague 8 | Czechia | Active, not recruiting |
| MEDICAL PLUS Research, s.r.o. Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Active, not recruiting |
| Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Uhz Klinische Forschung Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Medizentrum Essen Borbeck Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| diabetes-falkensee.de, ZKS Dr. Joerg Luedemann Coordinator of this site? Confirm its status | Falkensee | Germany | Active, not recruiting |
| Zentrum für klinische Forschung Dr. med. Bastian Kirsch Coordinator of this site? Confirm its status | Koeln | Germany | Active, not recruiting |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Coordinator of this site? Confirm its status | Oldenburg in Holstein | Germany | Active, not recruiting |
| Klinische Forschung Schwerin GmbH Coordinator of this site? Confirm its status | Schwerin | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Active, not recruiting |
| Instituto Gallego de Cirugía Ocular Coordinator of this site? Confirm its status | Ferrol | Spain | Active, not recruiting |
| Futuremeds Spain S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Active, not recruiting |
| Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Quironsalud Infanta Luisa Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Virgen de las Montañas Coordinator of this site? Confirm its status | Villamartín | Spain | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Stevenage | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Yate | United Kingdom | Unknown status |
| Lausmed Kft Coordinator of this site? Confirm its status | Baja | Hungary | Withdrawn |
| DRC Kft. Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Withdrawn |
| Szent Margit Rendelointezet Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Withdrawn |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Withdrawn |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Withdrawn |
| Borvo Clinic Kft Coordinator of this site? Confirm its status | Debrecen | Hungary | Withdrawn |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Kaposvar | Hungary | Withdrawn |
| Borbanya Praxis Egeszsegugyi Kft Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Withdrawn |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Withdrawn |
| Zala Varmegyei Szent Rafael Korhaz Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Withdrawn |
| - Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Hastings | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Nawton | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Nelson | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | New Lynn | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Silverdale | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Takapuna | New Zealand | Unknown status |
| Zdrowie Osteo-Medic Coordinator of this site? Confirm its status | Białystok | Poland | Active, not recruiting |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Diab Serwis Popenda Sp. j. Coordinator of this site? Confirm its status | Chorzow | Poland | Active, not recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci Coordinator of this site? Confirm its status | Kielce | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| ETG Lublin Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| EKAMED sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Clinicly Sp. z o.o. Coordinator of this site? Confirm its status | Opole | Poland | Active, not recruiting |
| Centrum Zdrowia Metabolicznego Pawel Bogdanski Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Centrum Medyczne Medyk Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Rzeszow | Poland | Active, not recruiting |
| Lukmed 2 Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Active, not recruiting |
| Velocity Nova Sp. z o. o. Velocity Skierniewice Coordinator of this site? Confirm its status | Skierniewice | Poland | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Etg Warszawa Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Centrum Medyczne Justmed Sp. z o.o. Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga Stasinska sp.p. Lekarzy Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | Vega Baja | Puerto Rico | Unknown status |
| - Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Annapolis | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Brownsville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Chickasha | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Cullman | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| - Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| - Coordinator of this site? Confirm its status | East Greenwich | United States | Unknown status |
| - Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Farmers Branch | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jupiter | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kingwood | United States | Unknown status |
| - Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Laurelton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lilburn | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Missoula | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Morrisville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pleasant View | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Riverdale | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Stamford | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Toluca Lake | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.