Heterozygous Familial HypercholesterolaemiaPhase 3AZURE-HeFHNCT07000136

A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH

A Phase 3 study testing AZD0780 in people with Heterozygous Familial Hypercholesterolaemia, run by AstraZeneca at 133 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heterozygous Familial Hypercholesterolaemia
What is being tested?: AZD0780
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 473 participants
Where: 133 sitesin 24 countries
Study dates: 10 Jun 2025to 4 Jan 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

•≥ 18 years of age at the time of signing the ICF.
Diagnosis of HeFH by genetic confirmation or a definite clinical diagnosis, ie, a score > x using the Dutch Lipid Network [Nordestgaard et al 2013] or equivalent as per internationally accepted diagnostic algorithms (AHA [Gidding et al 2015], US MEDPED [Williams et al 1993], Simon Broome [Scientific Steering Committee on behalf of the Simon Broome Register Group 1991], or Japanese Atherosclerosis Society Guidelines [Okamura et al 2024])
Fasting serum by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with HeFH and clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in HeFH without clinical ASCVD. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).
Thus, the background lipid-lowering therapy must consist of one of the following:
A high intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid :

Show all 9Show fewer

OR:
A maximally tolerated statin regimen - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended.
Participants must achieve a stable background lipid lowering therapy > 28 days before screening.

Who cannot join

Homozygous familial hypercholesterolaemia, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator.
Any of the following laboratory values at screening:
Calculated eGFR < 15 mL/min/1.73 m2
AST or ALT > 3 × ULN
TBL > 2 × ULN (except for patients with Gilberts syndrome, where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L)

Show all 13Show fewer

Creatine kinase > 5 × ULN
Urine albumin-to-creatinine ratio ≥ 500 mg/g
Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening
Inadequately treated hypothyroidism defined as TSH > 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study.
Use of gemfibrozil within 1 week prior to screening or planned use during the study.
Use of PCSK-9 inhibitors: evolocumab/alirocumab within 12 weeks of the screening visit or planned use during the study or inclisiran within 18 months of the screening visit or planned use during the study. Any other approved PCSK-9 inhibitor use within 5 half lives prior to the screening visit or planned use during the study.

Trial locations and contacts

133 sites in 24 countries.

Country

City, postcode or hospital

133 sites in 24 countries

United States19 sites

Research Site
Chattanooga, Tennessee, 37404
Research Site
Chicago, Illinois, 60607
Research Site
Cincinnati, Ohio, 45227
Research Site
Garden Grove, California, 92844
Research Site
Hammond, Louisiana, 70403
Research Site
Houston, Texas, 77043
Research Site
Humble, Texas, 77338
Research Site
Kingwood, Texas, 77345
Research Site
Las Vegas, Nevada, 89119
Research Site
Lima, Ohio, 45801
Research Site
McAllen, Texas, 78503
Research Site
Mesquite, Texas, 75149
Research Site
Miami Lakes, Florida, 33016
Research Site
Morganton, North Carolina, 28655
Research Site
New York, New York, 10029
Research Site
Orlando, Florida, 32807
Research Site
Peachtree Corners, Georgia, 30092
Research Site
Redmond, Washington, 98052
Research Site
San Diego, California, 92111

Other trials in United States

Japan18 sites

Research Site
Chūōku, 103-0027
Research Site
Fukushima, 960-1295
Research Site
Hamamatsu, 432-8580
Research Site
Ichikawa-shi, 272-8516
Research Site
Kanazawa, 920-8530
Research Site
Kanazawa, 920-8641
Research Site
Kishiwada-shi, 596-8522
Research Site
Kita-gun, 761-0793
Research Site
Komatsu-shi, 923-8560
Research Site
Minatoku, 108-0073
Research Site
Okayama, 700-0804
Research Site
Okayama, 702-8055
Research Site
Osaka, 543-8922
Research Site
Suita-shi, 564-8565
Research Site
Takatsuki-shi, 569-8686
Research Site
Tamanashi, 865-0016
Research Site
Urasoe-Shi, 901-2102
Research Site
Yokohama, 247-8581

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Argentina7 sites

Research Site
CABA, C1006ACC
Research Site
Ciudad Autonoma de Bs As, C1023AAB
Research Site
Ciudad de Buenos Aires, C1094AAD
Research Site
Ciudad de Buenos Aires, C1425AGC
Research Site
Mar del Plata, 7600
Research Site
Rosario, 2000
Research Site
Rosario, S2000PBJ

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Denmark7 sites

Research Site
Aarhus N, 8200
Research Site
Copenhagen, 2400
Research Site
Esbjerg, 6700
Research Site
Herlev, 2730
Research Site
Herning, 7400
Research Site
Hvidovre, DK-2650
Research Site
Viborg, 8800

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Canada6 sites

Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
London, Ontario, N6A 5A5
Research Site
Montreal, Quebec, H2W 1R7
Research Site
Québec, Quebec, G1V 4W2
Research Site
Trois-Rivières, Quebec, G9A 4P3
Research Site
Vancouver, British Columbia, V6Z2H2

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Sweden6 sites

Research Site
Gothenburg, 413 46
Research Site
Linköping, 581 85
Research Site
Lund, 22242
Research Site
Stockholm, 117 27
Research Site
Stockholm, 141 86
Research Site
Uppsala, 75185

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Brazil5 sites

Research Site
Campinas, 13060-080
Research Site
São Caetano do Sul, 09521-160
Research Site
São Paulo, 04004-030
Research Site
São Paulo, 04012-180
Research Site
São Paulo, 05403-000

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France5 sites

Research Site
Bron, 69677
Research Site
Dijon, 21079
Research Site
Marseille, 13005
Research Site
Paris, 75013
Research Site
Saint-Herblain, 44093

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Hungary5 sites

Research Site
Budapest, 1036
Research Site
Budapest, 1132
Research Site
Debrecen, 4032
Research Site
Nyíregyháza, 4400
Research Site
Székesfehérvár, 8000

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Norway5 sites

Research Site
Bodø, 8005
Research Site
Grålum, 1712
Research Site
Oslo, 0369
Research Site
Oslo, 0586
Research Site
Trondheim, 7030

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Slovakia5 sites

Research Site
Bratislava, 83101
Research Site
Bratislava, 83106
Research Site
Košice, 04022
Research Site
Nitra, 949 11
Research Site
Žilina, 010 01

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Spain5 sites

Research Site
A Coruña, 15006
Research Site
Barcelona, 08036
Research Site
Córdoba, 14004
Research Site
Reus, 43204
Research Site
Seville, 41013

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Turkey (Türkiye)5 sites

Research Site
Adana, 01060
Research Site
Afyonkarahisar, 03030
Research Site
Ankara, 06530
Research Site
Izmir, 35100
Research Site
İzmit, 41380

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Czechia4 sites

Research Site
Hradec Králové, 500 05
Research Site
Prague, 140 00
Research Site
Prague, 19800
Research Site
Uherské Hradiště, 686 01

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Finland4 sites

Research Site
Helsinki, 00290
Research Site
Kuopio, 70210
Research Site
Tampere, 33520
Research Site
Turku, 20520

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Netherlands4 sites

Research Site
Amsterdam, 1105 AZ
Research Site
Roosendaal, 4708 AE
Research Site
Rotterdam, 3015 GD
Research Site
Utrecht, 3584 CX

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South Korea4 sites

Research Site
Gyeonggi-do, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 120-752
Research Site
Seoul, 5278

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Taiwan4 sites

Research Site
Kaohsiung City, 80756
Research Site
Taichung, 40705
Research Site
Taipei, 10002
Research Site
Taipei, 11217

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Vietnam4 sites

Research Site
Hanoi, 100000
Research Site
Hồ Chí Minh, 9000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000

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Bulgaria3 sites

Research Site
Plovdiv, 4002
Research Site
Sofia, 1527
Research Site
Sofia, 1618

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Germany3 sites

Research Site
Berlin, 10559
Research Site
Dresden, 1307
Research Site
Leipzig, 04103

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Chile2 sites

Research Site
Santiago, 7770086
Research Site
Valdivia, 5090000

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New Zealand2 sites

Research Site
Christchurch, 8011
Research Site
Grafton, 1010

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Australia1 site

Research Site
Melbourne, 3004

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About this study

Official title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Heterozygous Familial Hypercholesterolaemia

This is a study to evaluate the efficacy and safety of AZD0780 in adults with HeFH and elevated LDL-C, either with clinical ASCVD and LDL-C levels of 55 mg/dL or higher or without clinical ASCVD and LDL-C levels of 70 mg/dL or higher. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study.

The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.

Read the detailed description

This is a randomised, double-blind, placebo-controlled, parallel-group Phase III study to evaluate the effect on the reduction of LDL-C and the safety and tolerability of AZD0780 versus placebo, administered as xx mg once daily orally, on top of a high intensity lipid-lowering regimen. The target population is adults ≥ 18 years of age with HeFH either with ASCVD and LDL-C ≥ 55 mg/dL, or without clinical ASCVD and LDL-C ≥ 70 mg/dL. The study will be conducted at approximately 170 centres in approximately 25 countries.

The screening period is up to 14 days (and may be conditionally extended), starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants will be randomised in a 2:1 ratio to either AZD0780 or placebo for a treatment period of 52 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 xx mg orally once daily during the treatment period, while those in the placebo group will receive matching placebo. The study will include approximately 405 randomised participants. An independent data monitoring committee will, on a regular basis, review accumulating data from the study, evaluate adverse effects of the IMP, and make recommendations regarding whether to halt or modify the study.

Conditions: Heterozygous Familial Hypercholesterolaemia
Being tested: AZD0780, Placebo
Keywords: Low-Density Lipoprotein Cholesterol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD0780Drug
Participants will receive daily oral dose of AZD0780
PlaceboDrug
Participants will receive daily oral dose of placebo

Study groups in NCT07000136
Study group	Role	What they receive
AZD0780	Experimental	Participants will receive daily oral dose of AZD0780 Receives: Drug: AZD0780
Placebo	Placebo comparator	Participants will receive daily oral dose of placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative change in LDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks
Measured: Baseline - 12 weeks

Secondary outcomes (9)

Relative change in LDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks in patients on background statin therapy at baseline
Measured: Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 70 mg/dL at 12 weeks in patients with baseline LDL-C ≥ 70 mg/dL
Measured: Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on the probability of LDL-C < 55 mg/dL at 12 weeks
Measured: Baseline - 12 weeks
Relative change in LDL-C from baseline to 28 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 28 weeks
Measured: Baseline - 28 weeks
Relative change in LDL-C from baseline to 52 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 52 weeks
Measured: Baseline - 52 weeks
Relative change in Apo B from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on apolipoprotein (Apo) B at 12 weeks
Measured: Baseline - 12 weeks
Relative change in non-HDL-C from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on non-high-density lipoprotein cholesterol (HDL-C) at 12 weeks
Measured: Baseline - 12 weeks
Relative change in total cholesterol from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on total cholesterol at 12 weeks
Measured: Baseline - 12 weeks
Relative change in Lp(a) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on lipoprotein(a) (Lp[a]) at 12 weeks
Measured: Baseline - 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20254 Jan 2027

First posted2 Jun 2025
Study start10 Jun 2025
Primary completion4 Jan 2027 (estimated)
Study completion4 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heterozygous Familial HypercholesterolaemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07000136
Sponsor's protocol ID: D7960C00013
Other IDs: 2025-520520-17, 2025
Acronym: AZURE-HeFH
Status last verified: Jul 2026
First submitted: 23 May 2025
Last updated: 16 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Recruiting
The ORIGIN-FH Study
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
RecruitingPhase 2/3
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Heterozygous Familial Hypercholesterolemia (HeFH)
Not yet recruitingPhase 2
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
Atherosclerosis, Cardiovascular Disease

All Heterozygous Familial Hypercholesterolaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Heterozygous Familial Hypercholesterolaemia
ClinicalTrials.gov ID: NCT07000136
Acronym / sponsor ID: AZURE-HeFH / D7960C00013
Conditions: Heterozygous Familial Hypercholesterolaemia
Keywords: Low-Density Lipoprotein Cholesterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 473 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Jun 2025 (actual)
Primary completion: 4 Jan 2027 (estimated)
Study completion: 4 Jan 2027 (estimated)
First posted: 2 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group

Arm	Type	Receives
AZD0780	Experimental	Drug: AZD0780Participants will receive daily oral dose of AZD0780
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive daily oral dose of placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

•≥ 18 years of age at the time of signing the ICF.
Diagnosis of HeFH by genetic confirmation or a definite clinical diagnosis, ie, a score > x using the Dutch Lipid Network [Nordestgaard et al 2013] or equivalent as per internationally accepted diagnostic algorithms (AHA [Gidding et al 2015], US MEDPED [Williams et al 1993], Simon Broome [Scientific Steering Committee on behalf of the Simon Broome Register Group 1991], or Japanese Atherosclerosis Society Guidelines [Okamura et al 2024])
Fasting serum by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with HeFH and clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in HeFH without clinical ASCVD. Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
Participants should receive a background lipid lowering regimen anticipated to achieve at least a ~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).
A high intensity LDL lowering regimen (i) A high intensity statin regimen, as defined by country specific guidelines - Oral combination therapy with ezetimibe and/or bempedoic acid is strongly recommended OR: (ii) A lower intensity statin regimen in combination with ezetimibe and/or bempedoic acid :

Key exclusion criteria (13 listed)

Homozygous familial hypercholesterolaemia, LDL apheresis or plasma apheresis within 12 months prior to screening, or any other underlying known disease or condition that may interfere with interpretation of the clinical study results as judged by the Investigator.
Any of the following laboratory values at screening:
Uncontrolled type 2 diabetes mellitus defined as HbA1c ≥ 9.5% at screening
Inadequately treated hypothyroidism defined as TSH > 1.5 ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening
Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months prior to screening or planned use during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD0780Participants will receive daily oral dose of AZD0780	Drug	AZD0780
PlaceboParticipants will receive daily oral dose of placebo	Drug	Placebo

Primary outcome

Relative change in LDL-C from baseline to 12 weeks
Time frame: Baseline - 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks

9 secondary outcomes

Relative change in LDL-C from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks
Time frame: Baseline - 12 weeks
Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks
Time frame: Baseline - 12 weeks
Relative change in LDL-C from baseline to 28 weeks
Time frame: Baseline - 28 weeks
Relative change in LDL-C from baseline to 52 weeks
Time frame: Baseline - 52 weeks
Relative change in Apo B from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in non-HDL-C from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in total cholesterol from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in Lp(a) from baseline to 12 weeks
Time frame: Baseline - 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
2025-520520-17-00-SUBSTANTIAL MODIFICATIONLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Related trials for Heterozygous Familial Hypercholesterolaemia

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Recruiting
The ORIGIN-FH Study
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
RecruitingPhase 2/3
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Heterozygous Familial Hypercholesterolemia (HeFH)
Not yet recruitingPhase 2
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
Atherosclerosis, Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

133 sites in 24 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0780 in people with Heterozygous Familial Hypercholesterolaemia, run by AstraZeneca at 133 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, Japan, Argentina, Denmark, Canada and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in LDL-C from baseline to 12 weeks (time frame: Baseline - 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07000136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.