Study of laroprovstat (AZD0780) tablets to lower cholesterol levels in adults with inherited high cholesterol condition (heterozygous familial hypercholesterolemia)

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What is this study about?

This study focuses on people with Heterozygous Familial Hypercholesterolemia, an inherited condition that causes high levels of LDL cholesterol (often called “bad” cholesterol) in the blood. The research evaluates a new medication called AZD0780 (laroprovstat), which is given as a film-coated tablet that patients take by mouth.

The purpose of this study is to determine how well AZD0780 works compared to placebo in lowering LDL cholesterol levels in patients who already take other cholesterol-lowering medications. The study will last for 52 weeks, during which participants will receive either AZD0780 or placebo in addition to their usual cholesterol-lowering treatments.

Throughout the study, researchers will monitor changes in various types of cholesterol and related substances in the blood, including apolipoprotein B, non-HDL cholesterol, total cholesterol, and lipoprotein(a). The main focus will be on measuring how much the LDL cholesterol levels change after 12 weeks of treatment.

1 Initial treatment period

You will receive either AZD0780 tablets or a placebo (a tablet that looks the same but contains no active medicine). Neither you nor your doctor will know which treatment you are receiving.

You will need to continue taking your current cholesterol-lowering medications throughout the study.

The treatment will be taken orally (by mouth) according to the prescribed schedule.

2 12-week assessment

After 12 weeks of treatment, your cholesterol levels will be measured to evaluate how well the medication is working.

The main focus will be on measuring your LDL-C (low-density lipoprotein cholesterol, often called ‘bad’ cholesterol).

Blood samples will be taken to measure various types of cholesterol and related substances in your blood.

3 28-week follow-up

Your cholesterol levels will be checked again after 28 weeks of treatment.

This assessment will help determine the longer-term effects of the medication.

4 52-week completion

The final assessment will occur after 52 weeks (one year) of treatment.

Your cholesterol levels will be measured one last time to evaluate the long-term effectiveness of the treatment.

Various measurements will be taken, including LDL-C, Apo B (a protein in lipoproteins), and other cholesterol-related substances.

Who Can Join the Study?

Must be at least 18 years old when signing the consent form
Must have Heterozygous Familial Hypercholesterolemia (HeFH) confirmed either through:
- Genetic testing, or
- Clinical diagnosis using recognized diagnostic criteria
Must have specific fasting blood cholesterol levels:
- If you have heart disease: LDL cholesterol level of at least 55 mg/dL
- If you don’t have heart disease: LDL cholesterol level of at least 70 mg/dL
Must be on stable cholesterol-lowering medications:
- Taking the highest tolerated dose of statin medication (drugs that lower cholesterol)
- Using these medications for at least 28 days before screening
- Preferably also taking a medication called ezetimibe
If unable to take high-dose statins, you may still qualify if:
- You can tolerate lower doses of statins, or
- You have documented side effects from at least 2 different statins, or
- You take other medications that prevent you from using statins

Who Cannot Join the Study?

Age below 18 years old or above 65 years old
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Current participation in other clinical trials
Uncontrolled high blood pressure (blood pressure consistently above 140/90 mmHg)
History of heart attack or stroke within the past 6 months
Severe liver disease (indicated by liver function tests more than 3 times the normal range)
Severe kidney disease (indicated by estimated glomerular filtration rate below 30 mL/min)
Active cancer or ongoing cancer treatment
Unable to provide informed consent
History of substance abuse within the past year
Taking medications that may interact with the study drug
Mental health conditions that could interfere with study participation
History of non-compliance with medical treatments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Oslo Universitetssykehus HF	Oslo	Norway
Kuopio University Hospital	Kuopio	Finland
Region Vaestmanland	Vasteras	Sweden
Premedix	Bratislava	Slovakia
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Region Oestergoetland	Linkoping	Sweden
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
St. Olavs Hospital HF	Trondheim	Norway
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD	Sofia	Bulgaria
Nordlandssykehuset HF	Bodo	Norway
Cardio D&R s.r.o. Kosice	Kosice	Slovakia
Diabeda s.r.o.	Bratislava	Slovakia
Kardiopraxis Schirmer	Kaiserslautern	Germany
Medivasa s.r.o.	Zilina	Slovakia
MUDr. Nina Zemkova s.r.o.	Uherske Hradiste	Czechia
Endokrinologie Cerny Most s.r.o.	Prague	Czechia
KardioBusak s.r.o.	Louny	Czechia
Complex Rendelo Med Zrt.	Szekesfehervar	Hungary
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
University Of Debrecen	Debrecen	Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Virgen del Rocío University Hospital	Sevilla	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Semmelweis University	Budapest	Hungary
Turku University Hospital	Turku	Finland
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Diagnostic Consultation Center XX-Sofia EOOD	Sofia	Bulgaria
Salut Sant Joan De Reus	Reus	Spain
Bravis Ziekenhuis	Roosendaal	The Netherlands
Region Midtjylland	Aarhus	Denmark
Akardo AB	Stockholm	Sweden
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Medifarma-98 Kft.	Nyiregyhaza	Hungary
Pirkanmaan hyvinvointialue	Tampere	Finland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Medikals s.r.o.	Piestany	Slovakia
Privat Doktor Egeszseguegyi Szolgaltato Zrt.	Budapest	Hungary
High Tech Medical Kft.	Budapest	Hungary
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Clinoxus s.r.o.	Prague	Czechia
Iuygufgfk Fqx Cytzaweu Ahm Ewkehsfvsgnj Mfncdasp	Prague	Czechia
Mgprgow Chhnrp Icsk Tjmhxxyc Yaoqdx Egxj	Sofia	Bulgaria
Clidslkcjwwyewfzihl Mrvtcptovw Syrwes Ac	Oslo	Norway
Hlcvxs Hwwlkjut	Herlev	Denmark
Cfxfkz Hfgpcpbavmd Ukifdqqlnnsad Dq Dlcqw	Dijon	France
Aeexzjjwww Pjwymcsh Hmvutfkm Dd Mzojpcoxk	Marseille	France
Uahsqub Ucjafwohil Hrazdelq	Uppsala	Sweden
Hemjvpaf Uycnvnyuvj Cdbivce Hwfuupku	Helsinki	Finland
Eqwtjme Ucwutjlzeejg Mvqxsii Cshsbit Rjtpmyljm (ztjxycu Mxm	Rotterdam	The Netherlands
Atqzfgaiq Ugw	Amsterdam	The Netherlands
Ibfechvni sxqtqs	Nitra	Slovakia
Clb Hduxquh Kbkl	Encs	Hungary
Kcdbwnjgttc ie Syszdijmmq	Berlin	Germany
Hovmoadv Ukswlwtmdgdrg dw A Cnbxsn	A Coruna Galicia	Spain
Ettyvxhws Kvysfxc Kzmr	Budapest	Hungary
Ujfveed Dpapkkbwtpo khbs	Teplice	Czechia

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.05.2025
Czechia	Not recruiting	30.05.2025
Denmark	Not recruiting	30.05.2025
Finland	Not recruiting	30.05.2025
France	Not recruiting	30.05.2025
Germany	Not recruiting	30.05.2025
Hungary	Not recruiting	30.05.2025
Norway	Not recruiting	30.05.2025
Slovakia	Not recruiting	30.05.2025
Spain	Not recruiting	30.05.2025
Sweden	Not recruiting	30.05.2025
The Netherlands	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 with an inherited condition that causes high cholesterol levels. The medication is being tested to see if it can help patients with a genetic condition called heterozygous familial hypercholesterolemia, which causes abnormally high cholesterol levels that can be difficult to treat with standard medications.

Heterozygous Familial Hypercholesterolemia – A genetic condition that causes high levels of LDL (bad) cholesterol from birth. People with this condition inherit one defective gene from one parent, affecting their body’s ability to remove cholesterol from the blood. It leads to consistently elevated cholesterol levels throughout life, particularly affecting LDL cholesterol. The condition results in the build-up of fatty deposits in blood vessels over time. The disorder affects the body’s ability to process cholesterol normally due to problems with specific proteins called LDL receptors.

Trial ID:

2025-520520-17-00

Protocol code:

D7960C00013

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of laroprovstat (AZD0780) tablets to lower cholesterol levels in adults with inherited high cholesterol condition (heterozygous familial hypercholesterolemia)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?