A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia

NCT06834932 | Recruiting Phase 2 DMC

• 1 other identifier: D7960C00008
• Study Type: interventional
• Target: 360
• Locations: 2 countries
• Sites: 43

Brief Summary

This is a randomised, double-blind, placebo-controlled, multi-centre, sequential Phase II and Phase III study that will evaluate the efficacy, safety, and PK of AZD0780 administered orally for up to 52 weeks in participants with elevated LDL-C. The study consist of 2 separate parts (Part A and Part B) approximately 60 participants will be randomised in Part A. There will be 2 cohorts in Part B (approximately 220 participants in Cohort 1 and 100 participants in Cohort 2).

Conditions

Dyslipidaemia

Keywords

AZD0780; Dyslipidaemia

Outcome Measures

Primary Outcomes (5)

• AZD0780 Concentrations in plasma (PART A)

  To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

  Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

• AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).

  To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

  Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

• AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)

  To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

  Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

• AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)

  To characterise the single dose and steady state PK of AZD0780 following oral administration of AZD0780 (PART A)

  Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)

• Relative change in LDL-C from baseline to 12 weeks (PART B)

  To compare the effect of treatment with AZD0780 versus placebo on LDL-C at 12 weeks (PART B)

  From baseline to 12 weeks (PART B)

Secondary Outcomes (8)

• Relative change from baseline of LDL-C at Week 4 (PART A)

  From baseline to Week 4 (PART A)

• Relative change in LDL-C from baseline to 12 weeks (PART B Cohort 2)

  From baseline to 12 weeks (PART B Cohort 2)

• Relative change in LDL-C from baseline to 12 weeks (PART B)

  From baseline to 12 weeks (PART B)

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

  From baseline to 12 weeks (PART B)

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

  From baseline to 12 weeks (PART B)

Other Outcomes (2)

• Number of participants with adverse events (PART A)

  From baseline up to Day 39 (PART A)

• Number of participants with adverse events (PART B)

  Cohort 1: From baseline up to Day 375 (PART B) Cohort 2: From baseline up to Day 95 (PART B)

Study Arms (8)

AZD0780 +Rosuvastatin Dose 1 (Part A)

EXPERIMENTAL

* Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next 28 days (Part A)

Drug: Rosuvastatin Dose 1; Drug: AZD0780

Placebo +Rosuvastatin Dose 1 (Part A)

PLACEBO COMPARATOR

* Participants will receive Rosuvastatin Dose 1 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for next 28 days (Part A)

Drug: Placebo; Drug: Rosuvastatin Dose 1

AZD0780 +Rosuvastatin Dose 2 (Part A)

EXPERIMENTAL

* Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive AZD0780 QD as add on for next for 28 days (Part A)

Drug: Rosuvastatin dose 2; Drug: AZD0780

Placebo + Rosuvastatin Dose 2 (Part A)

PLACEBO COMPARATOR

* Participants will receive Rosuvastatin Dose 2 QD for minimum 21 days (up to 28 days) * Then receive Placebo QD as add on for 28 days (Part A)

Drug: Placebo; Drug: Rosuvastatin dose 2

AZD0780 (Part B Cohort 1)

EXPERIMENTAL

• Participate will receive AZD0780 QD for 52 weeks (Part B Cohort 1)

Drug: AZD0780

Placebo (Part B Cohort 1)

PLACEBO COMPARATOR

• Participate will receive Placebo QD for 52 weeks (Part B Cohort 1)

Drug: Placebo

AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)

EXPERIMENTAL

* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive AZD0780 QD as add on for 12 weeks (Part B Cohort 2)

Drug: Rosuvastatin Dose 1; Drug: AZD0780

Placebo+Rosuvastation Dose 1 (Part B Cohort 2)

PLACEBO COMPARATOR

* Participate receive Rosuvastatin Dose 1 for 28 days. * Then receive Placebo QD as add on for 12 weeks (Part B Cohort 2)

Drug: Placebo; Drug: Rosuvastatin Dose 1

Interventions

Placebo DRUG

Administered orally as tablets

Placebo (Part B Cohort 1); Placebo + Rosuvastatin Dose 2 (Part A); Placebo +Rosuvastatin Dose 1 (Part A); Placebo+Rosuvastation Dose 1 (Part B Cohort 2)

Rosuvastatin Dose 1 DRUG

Administered orally as tablets

AZD0780 +Rosuvastatin Dose 1 (Part A); AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2); Placebo +Rosuvastatin Dose 1 (Part A); Placebo+Rosuvastation Dose 1 (Part B Cohort 2)

Rosuvastatin dose 2 DRUG

Administered orally as tablets

AZD0780 +Rosuvastatin Dose 2 (Part A); Placebo + Rosuvastatin Dose 2 (Part A)

AZD0780 DRUG

Administered orally as tablets

AZD0780 (Part B Cohort 1); AZD0780 +Rosuvastatin Dose 1 (Part A); AZD0780 +Rosuvastatin Dose 2 (Part A); AZD0780+Rosuvastatin Dose 1 (Part B Cohort 2)

Eligibility Criteria

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

You may qualify if:

• PART A
• Males, and females of non-childbearing potential, 18 to 55 years of age, at the time of signing the informed consent.
• Diagnosis of dyslipidaemia: and with fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \< 190 mg/dL (4.9 mmol/L) at screening (Visit 1).
• Fasting triglycerides \< 400 mg/dL (\< 4.52 mmol/L) at screening (Visit 1).
• Not on any LLTs for ≥ 8 weeks prior to screening (Visit 1), except for a heart-healthy lifestyle.
• No planned LLTs using during study participation.
• Body mass index ≥ 18 and ≤35 kg/m\^2 , weigh ≥50 kg and ≤120 kg.
• PART B
• Males, and females, ≥ 18 years of age, at the time of signing the informed consent.
• Meets one of the ASCVD status/risk categories and has a corresponding fasted LDL-C value at screening (Visit 1) .
• (1) Participants with clinical ASCVD, LDL-C ≥ 55 mg/dl (ultra-high risk) and ≥ 70 mg/dl (very high risk).
• (2) Participants without clinical ASCVD, at moderate to high risk for ASCVD at 10 years, LDL-C ≥ 100 mg/dl. ASCVD risk equivalents \[diabetes mellitus,LDL-C ≥ 4.9 mmol/L or TC ≥ 7.2 mmol/L, HeFH, CKD (stage 3-5)\] are also eligible.
• \. Fasting triglycerides \< 400 mg/dL (\< 4.52 mmol/L).
• \. Background LLTs:
• For Cohort 1: on a stable dose of LLTs including medications and supplements ≥ 28 days before screening (Visit 1). , that typically include moderate to high-intensity statins for ≥ 28 days before screening (LLTs include medications \[eg, statins, ezetimibe, niacin\] and supplements \[eg, omega-3 fatty acids\] that can affect cholesterol levels).

You may not qualify if:

• PART A
• Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
• Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.
• Homozygous familial hypercholesterolaemia, Know diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening (Visit 1).
• QTcF \> 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
• A LDL-C reduction that is \< 30% post rosuvastatin run-in period (Day -8).
• PART B
• Acute ischaemic ASCVD event within 7 days prior to screening (Visit 1).
• Any uncontrolled or serious disease.
• eGFR \< 15 mL/min/1.73m2 using the CKD-EPI 2021 (age, sex) equation at screening (Visit 1).
• Uncontrolled type 2 diabetes mellitus, defined as HbA1c ≥ 9.5% at screening (Visit 1).
• Heart failure with New York Heart Association Class IV.
• Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma) within 5 years prior to screening (Visit 1).
• Severe concomitant non-CVD with risk of life expectancy \< 2 years.
• Recipient of any major organ transplant, eg, lung, liver, heart, bone marrow, renal.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (43)

Research Site

Baotou, 14010, China

RECRUITING

Research Site

Beijing, 100029, China

RECRUITING

Research Site

Beijing, 100050, China

RECRUITING

Research Site

Bengbu, 233004, China

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Changchun, 130021, China

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Changchun, 130033, China

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Changde, 415000, China

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Changsha, 410015, China

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Changzhou, 272100, China

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Chengdu, 610000, China

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Chongqing, 402260, China

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Daqing, 163000, China

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Deyang, 618000, China

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Research Site

Guangzhou, 510100, China

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Guangzhou, 510220, China

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Hengyang, 421001, China

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Research Site

Heze, 274099, China

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Research Site

Linhai, 317000, China

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Research Site

Luoyang, 471000, China

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Research Site

Nanchang, 330009, China

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Nanchong, 637900, China

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Nanjing, 210009, China

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Research Site

Pingxiang, 337055, China

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Research Site

Qiqihar, 161000, China

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Research Site

Sanya, 572000, China

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Research Site

Shanghai, 200032, China

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Research Site

Shanghai, 200120, China

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Research Site

Shanghai, 310000, China

NOT YET RECRUITING

Research Site

Shenyang, 110004, China

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Research Site

Shenyang, 110016, China

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Research Site

Siping, 136000, China

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Research Site

Taiyuan, 030024, China

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Research Site

Tianjin, 300457, China

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Research Site

Wuhan, 430010, China

ACTIVE NOT RECRUITING

Research Site

Wuhan, 430030, China

ACTIVE NOT RECRUITING

Research Site

Wuhan, 430060, China

ACTIVE NOT RECRUITING

Research Site

Xi'an, 710068, China

COMPLETED

Research Site

Xianyang, 750004, China

RECRUITING

Research Site

Yinchuan, 750004, China

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Research Site

Zigong, 643021, China

ACTIVE NOT RECRUITING

Research Site

Hong Kong, 999077, Hong Kong

RECRUITING

Research Site

Hong Kong, Hong Kong

COMPLETED

Research Site

Shatin, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: February 19, 2025
• Study Start: December 6, 2024
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): February 22, 2027
• Last Updated: April 20, 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 Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (40); HK (3)