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
Sites (117)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kailera Clinical Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Kailera Clinical Site #1 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Kailera Clinical Site #2 Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Godoy Cruz | Argentina | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| Kailera Clinical Site #1 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Kailera Clinical Site #2 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Kailera Clinical Site #3 Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Kailera Clinical Site #1 Coordinator of this site? Confirm its status | San Nicolás de los Arroyos | Argentina | Unknown status |
| Kailera Clinical Site #2 Coordinator of this site? Confirm its status | San Nicolás de los Arroyos | Argentina | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Charlestown | Australia | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Heidelberg Heights | Australia | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Norwood | Australia | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Sippy Downs | Australia | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Kailera Clinical Site 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 |
| Tonus 2013 Ltd. Coordinator of this site? Confirm its status | Pazardzhik | 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 Centre Futuremeds EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Alexandrovska University Hospital 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 |
| University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD 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 |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Medical Centre "Pratia Clinic" EOOD 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 |
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Active, not recruiting |
| CTC Hodonin s.r.o. Coordinator of this site? Confirm its status | Hodonín | Czechia | Active, not recruiting |
| DiaKrnov s.r.o. Coordinator of this site? Confirm its status | Krnov | 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 |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | 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 |
| Klinische Forschung Dresden GmbH Coordinator of this site? Confirm its status | Dresden | 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 |
| Praxis Dr. med. Cornelia Brauer Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Diabeteszentrum Hamburg West (DZHW) Gemeinschaftspraxis Dr. Wendisch, Dr. Dahl und Prof. Dr. Aberle Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Zentrum für klinische Forschung Dr. med. Bastian Kirsch Coordinator of this site? Confirm its status | Koeln | Germany | Active, not recruiting |
| Ambenet GmbH Das Ambulante Behandlungsnetz Coordinator of this site? Confirm its status | Leipzig | 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 Quirónsalud Barcelona 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 |
| Hospital Quironsalud Infanta Luisa 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 |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Hounslow | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Soham | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Stevenage | United Kingdom | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Torpoint | United Kingdom | Unknown status |
| Lausmed Kft Coordinator of this site? Confirm its status | Baja | Hungary | Completed |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Obudai Egeszseguegyi Centrum Kft. Coordinator of this site? Confirm its status | Kaposvar | Hungary | Completed |
| KomplexLabor Kft. Coordinator of this site? Confirm its status | Kecskemét | Hungary | Completed |
| Borbanya Praxis Egeszsegugyi Kft Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Nelson | New Zealand | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Silverdale | New Zealand | Unknown status |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Zdrowia Metabolicznego Pawel Bogdanski Coordinator of this site? Confirm its status | Poznan | 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. 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 |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Zamość | Poland | Active, not recruiting |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Chickasha | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Cullman | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Jupiter | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Lilburn | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Mauldin | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Sun City | United States | Unknown status |
| Kailera Clinical Site Coordinator of this site? Confirm its status | Toluca Lake | United States | Unknown status |
| Kailera Clinical Site 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.