A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

NCT06173570 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: D7960C000062023-506197-12-00
• Study Type: interventional
• Target: 428
• Locations: 8 countries
• Sites: 55

Brief Summary

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

Conditions

Dyslipidemia

Keywords

Dyslipidemia,; Low-Density Lipoprotein Cholesterol

Outcome Measures

Primary Outcomes (1)

• Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12

  Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C \* 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.

  From first day of treatment up to week 12

Secondary Outcomes (19)

• Percent Change From Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

  From first day of treatment up to week 12

• Percent Change From Baseline of Total Cholesterol at Week 12

  From first day of treatment up to week 12

• Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

  From first day of treatment up to week 12

• Percent Change From Baseline of Triglycerides at Week 12

  From first day of treatment up to week 12

• Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

  From first day of treatment up to week 12

Study Arms (5)

Arm A

EXPERIMENTAL

AZD0780, Dose 1

Drug: AZD0780

Arm B

EXPERIMENTAL

AZD0780, Dose 2

Drug: AZD0780

Arm C

EXPERIMENTAL

AZD0780, Dose 3

Drug: AZD0780

Arm D

EXPERIMENTAL

AZD0780, Dose 4

Drug: AZD0780

Arm E

PLACEBO COMPARATOR

Placebo, matched for appearance

Drug: Placebo

Interventions

AZD0780 DRUG

AZD0780 administered orally, once daily for 12 weeks

Arm A; Arm B; Arm C; Arm D

Placebo DRUG

Placebo administered orally, once daily for 12 weeks

Arm E

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent.
• Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than 190 mg/dL (4.9 mmol/L) at screening.
• Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.
• Should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening.
• There should be no planned medication or dose change during study participation.
• Body mass index at or above 19.0 kg/m\^2.

You may not qualify if:

• History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any uncontrolled or serious disease, or any medical (e.g., known major active infection or major hematological, renal, metabolic, gastrointestinal, respiratory, or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk.
• Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) greater than 10 percent at screening.
• Acute ischemic cardiovascular event in the last 12 months.
• Heart failure with New York Heart Association (NYHA) Class III-IV.
• 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, e.g., lung, liver, heart, bone marrow, renal.
• LDL or plasma apheresis within 12 months prior to randomization.
• Uncontrolled hypertension.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (55)

Research Site

Huntsville, Alabama, 35801, United States

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Lincoln, California, 95648, United States

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Palm Springs, California, 92262, United States

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Santa Ana, California, 92704, United States

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Boca Raton, Florida, 33434, United States

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Hialeah, Florida, 33012, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32216, United States

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Indianapolis, Indiana, 46260, United States

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Louisville, Kentucky, 40213, United States

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New Windsor, New York, 12553, United States

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Greensboro, North Carolina, 27408, United States

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Fargo, North Dakota, 58104, United States

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San Marcos, Texas, 78666, United States

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Barrie, Ontario, L4N 7L3, Canada

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Brampton, Ontario, L6S 0C6, Canada

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Cambridge, Ontario, N1R 6V6, Canada

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Concord, Ontario, L4K 4M2, Canada

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Guelph, Ontario, N1H 1B1, Canada

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Toronto, Ontario, M6G 1M2, Canada

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Benešov, 256 01, Czechia

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Brandýs nad Labem, 250 01, Czechia

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Brno, 603 00, Czechia

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Louny, 440 01, Czechia

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Náchod, 547 01, Czechia

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Prague, 150 00, Czechia

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Příbram, 261 01, Czechia

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Teplice, 415 01, Czechia

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Uherské Hradiště, 68601, Czechia

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Aarhus, 8200, Denmark

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Herning, 7400, Denmark

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Hvidovre, 2650, Denmark

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Svendborg, 5700, Denmark

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Viborg, 8800, Denmark

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Budapest, 1027, Hungary

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Debrecen, 4032, Hungary

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Orosháza, 5900, Hungary

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Pécs, 7624, Hungary

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Chūōku, 103-0027, Japan

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Itabashi-ku, 173-0004, Japan

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Bratislava, 831 03, Slovakia

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Brezno, 977 01, Slovakia

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Lučenec, 984 01, Slovakia

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Prešov, 080 01, Slovakia

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Rožňava, 048 01, Slovakia

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Svidník, 08901, Slovakia

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Trebišov, 075 01, Slovakia

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A Coruña, 15006, Spain

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Barcelona, 08041, Spain

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Córdoba, 14004, Spain

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Ferrol, 15405, Spain

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Santiago(A Coruña), 15706, Spain

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Seville, 41004, Spain

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Seville, 41013, Spain

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Seville, 41071, Spain

Location

Related Publications (1)

• Koren MJ, Vega RB, Agrawal N, Xu Y, Barbour AM, Yu H, Wallerstedt E, Carter D, Middlemiss J, Twaddle L, McCarthy MC, Rosenmeier JB. An Oral PCSK9 Inhibitor for Treatment of Hypercholesterolemia: The PURSUIT Randomized Trial. J Am Coll Cardiol. 2025 Jun 3;85(21):1996-2007. doi: 10.1016/j.jacc.2025.03.499. Epub 2025 Mar 31.

  PMID: 40167413 DERIVED

Related Links

• Redacted CSP
• Redacted SAP
• Redacted CSR Synopsis

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The secondary endpoints - percent change from baseline in Lipoprotein-a, remnant cholesterol, and hsCRP at Week 12 - could not be reliably interpreted using the planned inferential statistics model due to individual unexpected values and skewed data. Therefore, the endpoint analyses use descriptive statistics to illustrate the data distribution for these parameters.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: Participants will be randomized with equal distribution across 5 parallel treatment arms to either placebo or one of four AZD0780 doses.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 15, 2023
• Study Start: January 19, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

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

US (14); CA (6); HU (4); ES (8); JP (2); DK (5); SL (7); CZ (9)