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

NCT07218900 | Recruiting Phase 2

• 1 other identifier: AZ-RU-00013
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Dyslipidaemia

Keywords

AZD0780; Dyslipidaemia; Low-Density Lipoprotein Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline - 12 weeks

Secondary Outcomes (6)

• Indicator for LDL-C < 70 mg/dL (< 1.8 mmol/L) at 12 weeks

  Baseline - 12 weeks

• Indicator for LDL-C < 55 mg/dL (< 1.4 mmol/L) at 12 weeks

  Baseline - 12 weeks

• Relative change in Apolipoprotein (Apo) B from baseline to 12 weeks

  Baseline - 12 weeks

• Relative change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to 12 weeks

  Baseline - 12 weeks

• Relative change in total cholesterol from baseline to 12 weeks

  Baseline - 12 weeks

Study Arms (2)

AZD0780 +Rosuvastatin

EXPERIMENTAL

Participants will receive Rosuvastatin for 28 days. Then receive AZD0780 on top of rosuvastatin, administered orally for 12 weeks

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

Drug: Placebo; Drug: Rosuvastatin

Interventions

Placebo DRUG

Administered orally as tablets

Placebo +Rosuvastatin

AZD0780 DRUG

Administered orally as tablets

AZD0780 +Rosuvastatin

Rosuvastatin DRUG

Administered orally as tablets

AZD0780 +Rosuvastatin; Placebo +Rosuvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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:
• 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).

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Aramil, 624002, Russia

RECRUITING

Research Site

Ivanovo, 153012, Russia

RECRUITING

Research Site

Moscow, 105554, Russia

RECRUITING

Research Site

Moscow, 111539, Russia

RECRUITING

Research Site

Moscow, 117292, Russia

RECRUITING

Research Site

Moscow, 121552, Russia

RECRUITING

Research Site

Perm, 614000, Russia

RECRUITING

Research Site

Saint Petersburg, 194156, Russia

RECRUITING

Research Site

Saratov, 410054, Russia

SUSPENDED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-centre, randomised, double-blind, placebo-controlled, parallel-group

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at : https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (9)