DyslipidaemiaPhase 2LAZURENCT07218900
A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein Cholesterol Levels (LDL-C) in Adult Participants With Dyslipidaemia
A Phase 2 study testing AZD0780 and Rosuvastatin in people with Dyslipidaemia, run by AstraZeneca at 8 sites in Russia.
Trial summary
This is a study to investigate the effect of AZD0780 tablets on low density lipoprotein cholesterol levels (LDL-C) compared with placebo tablets administered in combination with rosuvastatin tablets in adult Russian participants with dyslipidaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- AZD0780 and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 8 sitesRussia
- Study dates
- 13 Nov 2025to 3 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- History of clinical Atherosclerotic cardiovascular disease (ASCVD) or at risk for a first ASCVD event:
- Clinical ASCVD is defined as MI, stable or unstable angina, coronary or other arterial revascularisation, ischaemic stroke, or peripheral artery disease.
- A participant is considered at risk for a first ASCVD event if the participant has one or more of the following conditions: atherosclerotic vascular disease (≥ 50% stenosis in ≥ 2 coronary artery territories or in ≥ 2 vascular beds [coronary, carotid, lower extremity], diagnosed by any imaging modality), diabetes mellitus, hypertension, cigarette smoking, chronic kidney disease (moderate to severe stage), or obesity. Investigators can also use the ACC/AHA or ESC or national clinical guidelines for risk assessment to identify participants with at least moderate risk for ASCVD.
- Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event
- Participants should meet 1 of the following before screening:
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- On a stable dose of Lipid-lowering therapy (LLTs) including moderate statins.
- On a stable dose of LLTs without any statins (either have been previously treated or be statins treatment naïve).
- Not received treatment with any LLTs (either have been previously treated or be LLTs treatment naïve).
Who cannot join
- Homozygous familial hypercholesterolaemia, known diagnosis of heterozygous familial hypercholesterolaemia (HeFH), 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)
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- 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
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Research Site
Aramil, 624002
Research Site
Ivanovo, 153012
Research Site
Moscow, 105554
Research Site
Moscow, 111539
Research Site
Moscow, 117292
Research Site
Moscow, 121552
Research Site
Perm, 614000
Research Site
Saint Petersburg, 194156
About this study
Official title: A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of AZD0780 in Combination With Rosuvastatin on Low Density Lipoprotein Cholesterol in Participants With Dyslipidaemia (LAZURE)
This is a study to investigate the effect of AZD0780 tablets on low density lipoprotein cholesterol levels (LDL-C) compared with placebo tablets administered in combination with rosuvastatin tablets in adult Russian participants with dyslipidaemia. 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 136 days, including a screening period of up to 14 days, rosuvastatin run-in period of 28 days, treatment with AZD0780 or placebo for 84 days, and a safety follow-up period of 10 days.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to evaluate the effect of AZD0780 on the reduction of LDL-C, as well as its safety and tolerability, compared to placebo. The study drug will be administered orally once daily in addition to rosuvastatin for up to 12 weeks in participants receiving moderate-intensity statin therapy or not receiving any statin therapy. The target population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical Atherosclerotic cardiovascular disease (ASCVD) or ≥ 70 mg/dL and at risk for a first ASCVD event.
The study will be conducted at approximately 11 centres in Russia.
The screening period is up to 14 days, starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants who meet all screening inclusion criteria and do not meet any exclusion criterion will enter a run-in period with rosuvastatin for 28 days before randomisation. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 12 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 orally once daily in addition to rosuvastatin during the treatment period, while those in the placebo group will receive matching placebo in addition to rosuvastatin. The study will include approximately 76 randomised participants.
- Conditions
- Dyslipidaemia
- Being tested
- Placebo, AZD0780, Rosuvastatin
- Keywords
- AZD0780, Dyslipidaemia, Low-Density Lipoprotein Cholesterol
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered orally as tablets
AZD0780Drug
Administered orally as tablets
RosuvastatinDrug
Administered orally as tablets
| Study group | Role | What they receive |
|---|---|---|
| AZD0780 +Rosuvastatin | Experimental | Participants will receive Rosuvastatin for 28 days. Then receive AZD0780 on top of rosuvastatin, administered orally for 12 weeks Receives: Drug: AZD0780; Drug: Rosuvastatin |
| Placebo +Rosuvastatin | Placebo comparator | Participants will receive Rosuvastatin for 28 days. Then receive Placebo on top of rosuvastatin, administered orally for 12 weeks Receives: Drug: Placebo; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in Low-density lipoprotein cholesterol (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 (6)
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 Apolipoprotein (Apo) B from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on Apo B at 12 weeks
Measured: Baseline - 12 weeks
Relative change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on non-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 lipoprotein(a) (Lp[a]) from baseline to 12 weeks
To compare the effect of treatment with AZD0780 versus placebo on 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.
- First posted21 Oct 2025
- Study start13 Nov 2025
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218900
- Sponsor's protocol ID
- AZ-RU-00013
- Acronym
- LAZURE
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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. All request 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of AZD0780 in Combination With Rosuvastatin on Low Density Lipoprotein Cholesterol in Participants With Dyslipidaemia (LAZURE)
- ClinicalTrials.gov ID
- NCT07218900
- Acronym / sponsor ID
- LAZURE / AZ-RU-00013
- Conditions
- Dyslipidaemia
- Keywords
- AZD0780, Dyslipidaemia, Low-Density Lipoprotein Cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 21 Oct 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.
This is a study to investigate the effect of AZD0780 tablets on low density lipoprotein cholesterol levels (LDL-C) compared with placebo tablets administered in combination with rosuvastatin tablets in adult Russian participants with dyslipidaemia. 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 136 days, including a screening period of up to 14 days, rosuvastatin run-in period of 28 days, treatment with AZD0780 or placebo for 84 days, and a safety follow-up period of 10 days.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group Phase II study to evaluate the effect of AZD0780 on the reduction of LDL-C, as well as its safety and tolerability, compared to placebo. The study drug will be administered orally once daily in addition to rosuvastatin for up to 12 weeks in participants receiving moderate-intensity statin therapy or not receiving any statin therapy. The target population is adults ≥ 18 years of age with LDL-C ≥ 55 mg/dL and history of clinical Atherosclerotic cardiovascular disease (ASCVD) or ≥ 70 mg/dL and at risk for a first ASCVD event.
The study will be conducted at approximately 11 centres in Russia.
The screening period is up to 14 days, starts at the date of signed informed consent, and ends on the day before the randomisation visit. Participants who meet all screening inclusion criteria and do not meet any exclusion criterion will enter a run-in period with rosuvastatin for 28 days before randomisation. Participants will be randomised in a 1:1 ratio to either AZD0780 or placebo for a treatment period of 12 weeks and a 10-day safety follow-up. Those randomised to the AZD0780 group will receive AZD0780 orally once daily in addition to rosuvastatin during the treatment period, while those in the placebo group will receive matching placebo in addition to rosuvastatin. The study will include approximately 76 randomised participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-centre, randomised, double-blind, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| AZD0780 +Rosuvastatin | Experimental | Drug: AZD0780, Drug: RosuvastatinParticipants will receive Rosuvastatin for 28 days. Then receive AZD0780 on top of rosuvastatin, administered orally for 12 weeks |
| Placebo +Rosuvastatin | Placebo comparator | Drug: Placebo, Drug: RosuvastatinParticipants will receive Rosuvastatin for 28 days. Then receive Placebo on top of rosuvastatin, administered orally for 12 weeks |
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
- History of clinical Atherosclerotic cardiovascular disease (ASCVD) or at risk for a first ASCVD event:
- Fasting serum LDL-C by central laboratory at screening as follows: LDL-C ≥ 55 mg/dL (≥ 1.4 mmol/L) in participants with clinical ASCVD or ≥ 70 mg/dL (≥ 1.8 mmol/L) in participants without clinical ASCVD but at risk for a first ASCVD event
- Participants should meet 1 of the following before screening:
Key exclusion criteria (13 listed)
- Homozygous familial hypercholesterolaemia, known diagnosis of heterozygous familial hypercholesterolaemia (HeFH), 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 |
|---|---|---|
| PlaceboAdministered orally as tablets | Drug | Placebo +Rosuvastatin |
| AZD0780Administered orally as tablets | Drug | AZD0780 +Rosuvastatin |
| RosuvastatinAdministered orally as tablets | Drug | AZD0780 +Rosuvastatin, Placebo +Rosuvastatin |
Primary outcome
Relative change in Low-density lipoprotein cholesterol (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
6 secondary outcomes
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 Apolipoprotein (Apo) B from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Relative change in non-high-density lipoprotein cholesterol (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 lipoprotein(a) (Lp[a]) from baseline to 12 weeks
Time frame: Baseline - 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- 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. All request 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 shared.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0780 and Rosuvastatin in people with Dyslipidaemia, run by AstraZeneca at 8 sites in Russia.
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: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Low-density lipoprotein cholesterol (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?
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 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.