A study to evaluate the effect of orforglipron on cardiovascular health in adults with atherosclerotic cardiovascular disease and/or chronic kidney disease

3 1

What is this study about?

This study aims to investigate whether orforglipron can reduce the risk of serious health problems related to the heart and blood vessels. The research focuses on individuals living with Atherosclerotic Cardiovascular Disease, a condition where plaque builds up in the arteries, and or Chronic Kidney Disease, which is a long-term condition where the kidneys do not work as well as they should. Participants will be given either orforglipron, which is an oral tablet, or a placebo.

During the study, participants will be monitored over a period of time to see how the medication affects the occurrence of major health events. These events include myocardial infarction, commonly known as a heart attack, stroke, or being hospitalized due to heart failure. The study also looks at coronary revascularization, which is a procedure used to improve blood flow to the heart, and any deaths caused by any reason.

Who Can Join the Study?

  • You must have heart disease, which means a problem with the heart or blood vessels.
  • You must have kidney disease, which means your kidneys are not working as well as they should.
  • You may have both heart disease and kidney disease.
  • You must have atherosclerosis cardiovascular disease, which is a condition where the arteries (the tubes that carry blood through your body) become hardened and narrow due to a buildup of fats and cholesterol.
  • You must be part of the patient group.
  • You must be within the specified age range, which corresponds to being between 3 and 17 years old based on the provided codes.
  • The study includes both females and males.

Who Cannot Join the Study?

  • You cannot participate if you have type 1 diabetes, which is a condition where the body does not produce the insulin needed to manage blood sugar levels.
  • You cannot participate if you have experienced a serious heart condition within 60 days before the study starts.
  • You cannot participate if you have NYHA Class IV heart failure, which is the most severe stage of heart failure where symptoms of heart failure occur even while at rest.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
CHU Grenoble Alpes La Tronche France
DIACENTRUM Brandys n.L. s.r.o. Brandys Nad Labem Czechia
Frisius Heerenveen The Netherlands
Intern s.r.o. Ilava Slovakia
Spaolo s.r.o. Nove Mesto Nad Vahom Slovakia
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia Baia Mare Romania
Diabeteszentrum Hamburg West Hamburg Germany
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu Wroclaw Poland
Stichting OLVG Amsterdam The Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j. Ruda Slaska Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
Kormont Kluisbergen Belgium
Cardio Metabolic Centre Mattersburg Austria
Klinisches Forschungszentrum Dr. Hagemann Essen Germany

Other Sites

Site Name City Country Status
Hippokration Hospital Athens Greece
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
University Of Debrecen Debrecen Hungary
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
University General Hospital Of Ioannina Ioannina Greece
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
North Estonia Medical Centre Foundation Tallin Estonia
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Alexandra Hospital Athens Greece
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Stichting Radboud University Medical Center Nijmegen The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
University Of Szeged Szeged Hungary
Algemeen Ziekenhuis Klina Brasschaat Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Universita Degli Studi Di Brescia Brescia Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Servei De Salut De Les Illes Balears Palma Spain
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Hospital Universitario De La Ribera Alzira Spain
VIVIT Feldkirch Austria
Hospital Clinico Universitario De Valladolid Valladolid Spain
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Cardiomed S.R.L. Iasi Romania
Praglandia s.r.o. Prague Czechia
Specderm Poznanska Sp. j. Bialystok Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Clinmedica Research sp. z o.o. Skierniewice Poland
Saules seimos medicinos centras UAB Kaunas Lithuania
Kardio Chlumec s.r.o. Chlumec Nad Cidlinou Czechia
MUDr. Alena Vachova Ceske Budejovice Czechia
Medon Clinical Research Sp. z o.o. Warsaw Poland
B. Braun Avitum s.r.o. Trstena Slovakia
Kristavita UAB Jonava Lithuania
Tonus 2013 Ltd. Pazardzhik Bulgaria
Centre Hospitalier Louis Pasteur Le Coudray France
Kardiologie KarMa s.r.o. Poštovní Czechia
KardioInt s.r.o. Lékařský dům Géčko Ceske Budejovice Czechia
Diabetologie a endokrinologie, J.Venerová s.r.o. Prague Czechia
Centro Periférico de Especialidades Bola Azul Andalucia Spain
Centre Hospitalier Régional de la Citadelle Liege United States
PVN Kutato Kft. Budapest Hungary
Center for Clinical and Basic Research AS Tallin Estonia
ClinDiab Kft. Budapest Hungary
Centrum kardiovaskulární medicíny s.r.o Prague Czechia
Cardiogeneral Kft. Budapest Hungary
KomplexLabor Kft. Kecskemet Hungary
Estendo Private Clinic Tallin Estonia
IRCCS Policlinico San Donato San Donato Milanese Italy
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Meander Medical Center Amersfoort The Netherlands
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Jan Yperman Ziekenhuis Ieper Belgium
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Klinik Hietzing Vienna Austria
In Vivo Sp. z o.o. Bydgoszcz Poland
Bravis Ziekenhuis Roosendaal The Netherlands
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes La Louviere Belgium
Slingeland Ziekenhuis Doetinchem The Netherlands
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Regia Med Kft. Szekesfehervar Hungary
Ziekenhuis Oost Limburg Genk Belgium
Gelre Hospitals Zutphen The Netherlands
Easydiet S.R.L. Bucharest Romania
Centro Cardiologico Monzino S.p.A. Milan Italy
CHU Gabriel-Montpied Clermont Ferrand France
Groene Hart Ziekenhuis Gouda The Netherlands
Hospital Edouard Herriot Lyon France
Hospital Santa Maria Della Misericordia Perugia Italy
Jeroen Bosch Ziekenhuis Stichting S-Hertogenbosch The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Nutrilife S.R.L. Bucharest Romania
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Nicodiab S.R.L. Bucharest Romania
Clinica Korall S.R.L. Satu Mare Romania
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Algemeen Ziekenhuis Damiaan Oostende Ostend Belgium
Gensan S.R.L. Sibiu Romania
Cabinet Medical Dr Geru S.R.L. Timisoara Romania
Medicali’s S.R.L. Timisoara Romania
Mediab S.R.L. Targu Mures Romania
Medizentrum Essen Borbeck Essen Germany
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Medical Center Teodora EOOD Ruse Bulgaria
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Cracow Poland
Ambulatorium Sp. z o.o. Elblag Poland
Diakonessenhuis Stichting Utrecht The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
DIA MED CENTRUM s.r.o. Zilina Slovakia
DRC Kft. Balatonfured Hungary
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Het Van Weel-Bethesda Ziekenhuis Dirksland The Netherlands
Medivasa s.r.o. Zilina Slovakia
medicoKIT GmbH Goch Germany
Lotus Med S.R.L. Bucharest Romania
Medispektrum s.r.o. Petrzalka Slovakia
Diabdana S.R.L. Oradea Romania
EB FlevoResearch B.V. Almere The Netherlands
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu Balotesti Romania
MUDr. Jana Parkányiová Prague Czechia
Imelda General Hospital Putte Belgium
Azienda Ospedaliero Universitaria S.Anna Ferrara Italy
Istituto Clinico Humanitas Rozzano Italy
Hospital Universitario Hm Monteprincipe Boadilla Del Monte Spain
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj Radom Poland
Ordination Dr. Evelyn Fliesser-Görzer St. Stefan ob Stainz Austria
Centre Hospitalier Universitaire de Nantes – L’ Hopital l’hôtel-Dieu Nantes France
AOU Bologna Policlinico di Sant’Orsola Bologna Italy
Hospital Clínico de Valencia Valencia Spain
Zdrowie Osteo-Medic Bialystok Poland
Diavital Jesenice s.r.o. Jílové u Prahy Czechia
Cbuxuiuib Ugeeisbhbeolxa Schhpowkr Woluwe-Saint-Lambert Belgium
Hsdycomf Vjtv dwfumvhl Barcelona Spain
Mdtghfj Unnajgtfgg Of Gmsz Graz Austria
Cqzfhu Hfgkqhjefwk Rpevwaja Uvxmfuepuvhnh Df Tzmeu Tours France
Cvwc Dx Nyphu Vandoeuvre Les Nancy France
Iaeaggdt Urh Kaunas Lithuania
Avetou Mmvxzei Cklylj Sdxp Thessaloniki Greece
Obvlbjgsiisuuh Lcdr Gkev Linz Austria
Hhgjazkt Uuuvldgvvbhin Muyhtlz Db Vbwbdcmrdc Santander Spain
Cqbuqrg Mpuwebl Dr Dcobuzexxs Sx Tnxzhslhz Akbhemnzh Ntjiyg Smxzdt Brasov Romania
Hfkwujni Ujspekrqtwjxgm Sruqjhyevg &enprft Hvlzjah dg Hlcofiatotj STRASBOURG, Alsace France
Mplow Mhkhwcuz Katbma smasfm Ostrava Czechia
Cjt Deo Pfsleladx Czilqdty Targu Mures Romania
Mkukd Kifnjc sevvjb Prague Czechia
Csh Hwqhcib Keai Encs Hungary
Mboymkp Ciuhmp Bgcthtee Lcmt Yambol Bulgaria
Scspxxbvcql Psauhvcbz Zrnkws Zqljulpr Oxucob Zyfitkqqoj W Wmtdjhmwa Wyszkow Poland
Myrrwre Czjvlm Nlx Phodncjaqu Gyzjela Luhc Gabrovo Bulgaria
Decbmilumwaean Sncyel Targu Mures Romania
Ckx dl Nohpm Huhqsht Pgokihk 2 Nice France
Mqmrzyfwnqr Sggdvos Sbmtezyxpdhlngm W Wahbokfne Warsaw Poland
Kalgun Ljbd Gdansk Poland
Cqancmm Smfaoqyw Dbapxqbjlil Kytanfdgenczbxa „ehqxcytshg Mq Żkwcgjnm Er Żgrkclp Tarnow Poland
Dab Dzrzsdnrxed &axdm Drc Gqrwqade Gprioxgwzshui Fqfi Iterpv Mbzblmf Uxr Kpihpjfqczu Oy Vienna Austria
Ksghsnndzea Sdyyalhxpw Uey Kaunas Lithuania
Liwgc Vzcapp Oc Paernu Estonia
Dsl Bwsqawgyg Hizfjgxkx Essen Germany
Mdpfk Tpgoy Eswlgawdrvq Krnov Czechia
Dtyrywzopdpi Mjpxiq Sufavm Ploiesti Romania
Duud coqsgsk sdocfv Havirov Czechia
Dirhhsrp satqua Poprad Slovakia
Mmlag Zzwnhv smdjbs Trencin Slovakia
Dhwusbx salbwi Bratislava Slovakia
Usizymw Elacargszekd Nvqeprwup Kned Budapest Hungary
Sswzz Mkgmqp Rayvygoeflclty Nqedkthur Kdal Budapest Hungary
Cnd Chchivtv Rwpmqwqf Ncwxhkw Snjkcq Bucharest Romania
Ckj Cokqfzfjbom &xhprpe Dda Mfctsv Ckhggq Dnwrn Baia Mare Romania
Emm Lljkrs Lublin Poland
Andazvavx Uag Amsterdam The Netherlands
Afsmewe Cpkuqxu Sje z ovay Sacv Ruda Slaska Poland
Apbduhf Okjnvbljtgf Ubuiliwrovnek Proxk Parma Italy
Rnhbdliao Zongivwjrt Stkbhmvvf Arnhem The Netherlands
Szuowivfe Mvvlxxz Zfoodbasji Groningen The Netherlands
Hotjsnmo Utyuokhdhyjbk Dc Bwdtdqf Badajoz Spain
Erdfysx Mechelen Belgium
Dsbsun Mpp Sqcqxd Bucharest Romania
Hmumcptt Uqmzzummmjcmj Hlojvdvb Tsqxq y Pulatm Iysrupuy Cokdyh dncynogwyyjmupzik (jgkz Badalona Spain
Zpmfwfz ftp kjxyftbow Ffdnpttct Cologne Germany
Gbdcywqynscmrbjmifl Mipilinikjijf &ubqodw Dsn Lh Pyzwehupiw Tn Duulnxvp Stuhr Germany
Pumjuxalrdy Ds Miatm Slvror Monza Italy
Hxstcvehmnl Ubd Kaunas Lithuania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.02.2026
Belgium Belgium
Recruiting
01.02.2026
Bulgaria Bulgaria
Recruiting
01.02.2026
Czechia Czechia
Recruiting
01.02.2026
Estonia Estonia
Recruiting
01.02.2026
France France
Recruiting
01.02.2026
Germany Germany
Recruiting
01.02.2026
Greece Greece
Recruiting
01.02.2026
Hungary Hungary
Recruiting
01.02.2026
Italy Italy
Recruiting
01.02.2026
Lithuania Lithuania
Recruiting
01.02.2026
Poland Poland
Recruiting
01.02.2026
Romania Romania
Recruiting
01.02.2026
Slovakia Slovakia
Recruiting
01.02.2026
Spain Spain
Recruiting
01.02.2026
The Netherlands The Netherlands
Recruiting
01.02.2026

Trial locations

Orforglipron is an oral medication being studied to see if it can help reduce the risk of major heart-related problems in people who already have heart disease or kidney disease.

Chronic Kidney Disease – This condition occurs when the kidneys gradually lose their ability to filter waste products from the blood. As the disease progresses, the kidneys become less efficient at maintaining the body’s fluid and chemical balance. This decline can lead to an accumulation of harmful substances in the body. The damage often develops slowly over many years.

Atherosclerosis Cardiovascular Disease – This condition involves the buildup of fats, cholesterol, and other substances in and on the artery walls. These deposits, known as plaques, cause the arteries to narrow and harden over time. As the arteries become more restricted, blood flow to vital organs and tissues is reduced. This process can eventually lead to serious complications involving the heart or brain.

Trial ID:
2025-523123-22-00
Protocol code:
J2A-MC-GZPW
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to compare the effects of BI 690517 and spironolactone on kidney function in patients with heart failure, cardiovascular disease, or chronic kidney disease

    Recruiting

    2 1 1 1
    The Netherlands
  • Effect of levothyroxine on kidney function in patients at risk of hypothyroidism after partial thyroid surgery

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Denmark