Study of AZD0780 in patients with high cholesterol and heart disease or risk of heart disease to lower bad cholesterol levels

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What is this study about?

This study focuses on patients with hyperlipidemia (high levels of blood fats) and atherosclerotic cardiovascular disease, a condition where arteries become hardened and narrowed. The study will test a new medication called AZD0780 (laroprovstat) in people who have high levels of “bad” cholesterol (also known as LDL cholesterol) despite taking their usual cholesterol-lowering medicines.

The purpose of this research is to determine how well AZD0780 works compared to placebo in lowering LDL cholesterol levels after 12 weeks of treatment. The medication comes as a film-coated tablet that is taken by mouth. Some participants will receive AZD0780, while others will receive a placebo.

The study will last for 52 weeks (one year), during which participants will continue taking their regular cholesterol-lowering medications. Throughout the study, researchers will measure various types of cholesterol and other blood fats, including apolipoprotein B, non-HDL cholesterol, and lipoprotein(a), to understand how well the treatment works.

1 Initial assessment and medication start

Your blood cholesterol levels will be measured after fasting

You will receive AZD0780 tablets or placebo (inactive substance) tablets for oral use

You will continue your current cholesterol-lowering medications, including statins if you are taking them

2 12-week assessment

Your blood cholesterol levels will be measured again after 12 weeks of treatment

The main focus will be on measuring your LDL-C (bad cholesterol) levels

Additional blood tests will check other types of fats in your blood, including: Apo B, non-HDL-C, total cholesterol, and Lp(a)

3 28-week assessment

Your blood cholesterol levels will be checked again at 28 weeks

The focus remains on measuring changes in your LDL-C levels

4 52-week assessment

A final measurement of your blood cholesterol levels will be taken at 52 weeks

This completes one year of participation in the study

The main focus will be on measuring the long-term changes in your LDL-C levels

Who Can Join the Study?

  • Must be at least 18 years old when signing the consent form
  • Must have either:
    • A history of heart and blood vessel disease (like heart attack, chest pain, stroke, or artery problems), or
    • Be at risk for heart disease due to conditions like:
      • Narrowed arteries in multiple areas
      • Diabetes
      • High blood pressure
      • Smoking
      • Kidney disease
      • Obesity
  • Must have specific levels of cholesterol (LDL-C) in blood tests:
    • At least 55 mg/dL if you have existing heart disease
    • At least 70 mg/dL if you are at risk but don’t have heart disease yet
  • Must be taking the highest tolerated dose of cholesterol-lowering medications (statins) with:
    • A stable dose for more than 28 days
    • If unable to take high-dose statins, must be on lower doses
    • If not taking any statins, must have documented side effects from trying at least 2 different statins
  • Both men and women can participate

Who Cannot Join the Study?

  • History of serious allergic reactions or severe sensitivity to any medications
  • Currently pregnant or breastfeeding women
  • Severe liver problems (as indicated by liver function tests more than 3 times the normal upper limit)
  • Uncontrolled high blood pressure (blood pressure readings consistently above 160/100 mmHg)
  • Recent heart attack or stroke (within the last 6 months)
  • Active cancer or ongoing cancer treatment
  • Participation in another clinical trial within the past 30 days
  • Severe kidney disease (with creatinine clearance less than 30 mL/min – a measure of kidney function)
  • History of muscle problems related to cholesterol-lowering medications
  • Uncontrolled diabetes (blood sugar levels consistently above normal range)
  • Taking medications that could interact with the study drug
  • History of substance abuse within the past year
  • Mental health conditions that could affect ability to comply with study procedures
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Of Debrecen Debrecen Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Hospital Universitario da A Coruna A Coruna Galicia Spain
Virgen del Rocío University Hospital Sevilla Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Universitaetsklinikum Muenster AöR Munster Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
University Of Szeged Szeged Hungary
Universitaet Leipzig Leipzig Germany
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Technische Universitaet Dresden Dresden Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
Medcenter Nova Clinic Ltd. Varna Bulgaria
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Slaskie Centrum Chorob Serca W Zabrzu Zabrze Poland
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Milan Kvapil s.r.o. Prague Czechia
CRU Hungary Kft. Encs Hungary
Medic Trials ST UG (haftungsbeschraenkt) Berlin Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
Kardio Michal Cepelak s.r.o. Klatovy Czechia
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen Munich Germany
University Medicine Greifswald Greifswald Germany
Synexus Polska Sp. z o.o. Poznan Poland
Hospital Universitario Virgen De Valme Sevilla Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Of Pecs Pecs Hungary
Futuremeds Sp. z o.o. Wroclaw Poland
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Smo Md GmbH Magdeburg Germany
MVZ im Altstadt-Carree Fulda GmbH Fulda Germany
Studienzentrum Bocholderstrasse Essen Germany

Other Sites

Site Name City Country Status
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Interna SK s.r.o. Svidnik Slovakia
Coromed-Smo Kft. Pecs Hungary
Clinexpert Kft. Budapest Hungary
Medicus Services s.r.o. Brandys Nad Labem Czechia
Kardiomed s.r.o. Lučenec Slovakia
Simplex Kft. Nyiregyhaza Hungary
MUDr. Kanderkova s.r.o. Namestovo Slovakia
PVN Kutato Kft. Budapest Hungary
Privat Doktor Egeszseguegyi Szolgaltato Zrt. Budapest Hungary
Klinische Forschung Karlsruhe GmbH Karlsruhe Germany
KliFoCenter GmbH Witten Germany
Innera s.r.o. Benesov Czechia
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD Dupnitsa Bulgaria
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Ośrodek Badań Klinicznych LabMed Agnieszka Karczmarczyk, Filip Karczmarczyk s.c. Szczecin Poland
Gyncentrum Sp. z o.o. Katowice Poland
Kardiologische Praxis Wermsdorf Wermsdorf Germany
Klinische Forschung Schwerin GmbH Schwerin Germany
Szpital Specjalistyczny im. J. Dietla w Krakowie Cracow Poland
Gabinety Lekarskie Maciej Karcz Warsaw Poland
EMED Centrum Uslug Medycznych Ewa Smialek Rzeszow Poland
Praxis Dr. med. Cornelia Bauer Hamburg Germany
Gemeinschaftspraxis Dres. Haggenmiller/Jeserich Nürnberg Germany
Diabetologische Schwerpunktpraxis Hohenmölsen – Weißenfels Hohenmölsen Germany
MUDr. Zdenek Pistek Uherske Hradiste Czechia
Kardiologicka ambulance MUDr. Ferkl s.r.o. Trutnov Czechia
Zentrum für klinische Studien Bad Homburg Bad Homburg Germany
Il Dtl srkdds Lučenec Slovakia
Mdjhyekc sxfoau Presov Slovakia
Chmcvyq Kibj Szekszard Hungary
Sbmxtoi Emwxdhohluu Kqwu Kalocsa Hungary
Vpaluwgu Gcso Amberg Germany
Kmyejexaguynav Geejnfjrfitqydyivtw Aa Pjdk Srfapusyp Potsdam Germany
Zrzeej Enllgkykgcxqn Sknaavpuh Budapest Hungary
Elmksw Suo z omtu Lublin Poland
Cqk Mlm Cpcrga Plock Poland
Cphdcqd Rwhrrzwseqqdr i Kdrzhlrwmdk Slatkxaox Powmbonrjl Soqnpv Jzttu Kedzierzyn-Kozle Poland
Ksgzljr Swi z os og Ostrow Mazowiecka Poland
Kozdaw Crssbsb siweit Chlumec Nad Cidlinou Czechia
Ccllbyifjomtg Cmb Gfxk Frankfurt Germany
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Abenvoanja Fsx Ixuaortzvm Pqkomnjj Fbu Sutdicopxgp Mdkygjc Cynu Krqge Kmarcflqdxe Eqmo Sliven Bulgaria
Ilgrauohqqgf Pmrifhat Lzujxxjo Mkzrye Tbuueqiopwy Lublin Poland
Imucvfbo syzdoq Vinica Slovakia
Mruqj Mimdyd Lnrnmb Prague Czechia
Etpwmcskp sawmgf Prague Czechia
Kehcom Lfd ayvbruqtb sqzguj Ceske Budejovice Czechia
Meddv Snpzde Pweoar Jílové u Prahy Czechia
Mobns Stury Jkzeh sjkiak Prague Czechia
Dqg Szvo ét Tydne Kdp Veszprem Hungary
Gbaryaxenx San z owfr Poznan Poland
Funcpmjpjg Guwb Offenbach Am Main Germany
Dtlewwfvae Cldxhrrgzt Cghwvl 1 Vikyabqsm Eaen Velingrad Bulgaria
Hkhb Temx Mvxmwot Kftb Budapest Hungary
Edarhogcl Krvuigr Kifk Budapest Hungary
Kugxlysfnyxm sfkjqt Levice Slovakia
Ckgdteftuicjs Kxlk Budapest Hungary
Vsiedybb Celixfta Rqnmdfhs Gcldocx Gueg Hamburg Germany
Cfbhnrrhgdlo Kkwk Balatonfured Hungary
Mfeuijxssbow Kfxk Nyiregyhaza Hungary
Eycsc Dgankobzqqbjubm Pfrvixdn Bqfsqbljt Sclpaceq Sxxawm Barcelona Spain
Kaqqaqwro Fmfxtzqwq Hryfsiwnmqekul Gqoc Hanover Germany
Kchwyuyxg Frspkkmwr Dooqggf Gnnf Dresden Germany
Jbrxmmzsssdmnxwavtup Vbhthmqdq Hjhpwhu Grgb Kwmhqyelzfiqmzjylokuc Szolnok Hungary
Culbtduo Buqy Szbyrhvyj Svs z olvx Sufu Lublin Poland
Mrcdoser ssuoyz Bratislava Slovakia
Dti Kouw Balatonfured Hungary
Axvojisps Mbfyfdj Cfxrsg Ope Dupnitsa Bulgaria
Celksh Dnsunjc seyvkn Kgqkao Kosice Slovakia
Pqzatqyoad Kxuq Bekescsaba Hungary
Dbjwwnp slypvk Bratislava Slovakia
Kubasrknsfbt Sygxuwvn Kaiserslautern Germany
Fupxsmodaagydcv Dwkzewiloqvwurbi Bbodqqiuegbhmvaygkfz mek Dresden Germany
Mwuaech slpslt Malacky Slovakia
Uby Kuctvkyyb Fwbqjcxwv Essen Germany
Cfv Smvwzwetuxotjhb Hweymtz Munich Germany
Gtooqqpqbykahiwtzez Mcriafeqdiduu &epyntz Dri Lu Pjnpkkwjqd Td Dzvdqueh Stuhr Germany
Kxjgqeqihfqnb afsogbfze srtzbh Příbram Czechia
Uscuswc Dvyhrexqvuc kmjb Teplice Czechia
Ckshan Ccwkkwl Geg Bremen Germany
Tpfdhztuie shvgfi Roznava Slovakia
Amjdx Twxay Rthscmit Kfwq Oroshaza Hungary
Miucvu scxywt Hodonin Czechia
Hvdszhqbifcpsds ac Gjzazaytwwfnn Essen Germany
Pwcyvf Dbf Txbonpuktu Markkleeberg Germany
Dtyxovrkmntambnqnbjjyaa Chhjba 1 Sv Klojtauokf Vavde Lzyz Varna Bulgaria

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
30.05.2025
Czechia Czechia
Not recruiting
30.05.2025
Germany Germany
Not recruiting
30.05.2025
Hungary Hungary
Not recruiting
30.05.2025
Poland Poland
Not recruiting
30.05.2025
Slovakia Slovakia
Not recruiting
30.05.2025
Spain Spain
Not recruiting
30.05.2025

Trial locations

AZD0780 is an investigational medication being studied for its effects on lowering LDL cholesterol (often called “bad” cholesterol) in patients who have high cholesterol levels. This medication is being tested in people who either have existing cardiovascular disease or are at risk of developing cardiovascular problems. The medication is designed to help reduce cholesterol levels in the blood, which may help prevent heart disease and related complications.

Investigated Diseases:

Hyperlipidemia – A condition characterized by elevated levels of lipids (fats) in the blood, particularly cholesterol and triglycerides. The condition develops gradually over time and can be influenced by both genetic factors and lifestyle choices. It often occurs without noticeable symptoms but leads to fatty deposits in blood vessels. The condition affects how the body processes and stores fats from food.

Atherosclerotic cardiovascular disease – A condition where plaque builds up inside the arteries, causing them to narrow and harden over time. The plaque consists of fat, cholesterol, calcium, and other substances found in the blood. As arteries become narrower, blood flow to various parts of the body becomes restricted. The process develops gradually over many years and can affect arteries throughout the body.

Trial ID:
2025-520521-21-00
Protocol code:
D7960C00012
Trial Phase:
Therapeutic confirmatory (Phase III)

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