DyslipidemiaPhase 2PURSUITNCT06173570
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
A Phase 2 study testing AZD0780 in people with Dyslipidemia, run by AstraZeneca at 55 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- 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
- 428 participants
- Where
- 55 sitesin 8 countries
- Study dates
- 19 Jan 2024to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
55 sites in 8 countries.
55 sites in 8 countries
United States14 sites
Research Site
Boca Raton, Florida, 33434
Research Site
Fargo, North Dakota, 58104
Research Site
Greensboro, North Carolina, 27408
Research Site
Hialeah, Florida, 33012
Research Site
Huntsville, Alabama, 35801
Research Site
Indianapolis, Indiana, 46260
Research Site
Inverness, Florida, 34452
Research Site
Jacksonville, Florida, 32216
Research Site
Lincoln, California, 95648
Research Site
Louisville, Kentucky, 40213
Research Site
New Windsor, New York, 12553
Research Site
Palm Springs, California, 92262
Research Site
San Marcos, Texas, 78666
Research Site
Santa Ana, California, 92704
Czechia9 sites
Research Site
Benešov, 256 01
Research Site
Brandýs nad Labem, 250 01
Research Site
Brno, 603 00
Research Site
Louny, 440 01
Research Site
Náchod, 547 01
Research Site
Prague, 150 00
Research Site
Příbram, 261 01
Research Site
Teplice, 415 01
Research Site
Uherské Hradiště, 68601
Spain8 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 08041
Research Site
Córdoba, 14004
Research Site
Ferrol, 15405
Research Site
Santiago(A Coruña), 15706
Research Site
Seville, 41004
Research Site
Seville, 41013
Research Site
Seville, 41071
Slovakia7 sites
Research Site
Bratislava, 831 03
Research Site
Brezno, 977 01
Research Site
Lučenec, 984 01
Research Site
Prešov, 080 01
Research Site
Rožňava, 048 01
Research Site
Svidník, 08901
Research Site
Trebišov, 075 01
Canada6 sites
Research Site
Barrie, Ontario, L4N 7L3
Research Site
Brampton, Ontario, L6S 0C6
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Concord, Ontario, L4K 4M2
Research Site
Guelph, Ontario, N1H 1B1
Research Site
Toronto, Ontario, M6G 1M2
Denmark5 sites
Research Site
Aarhus, 8200
Research Site
Herning, 7400
Research Site
Hvidovre, 2650
Research Site
Svendborg, 5700
Research Site
Viborg, 8800
Hungary4 sites
Research Site
Budapest, 1027
Research Site
Debrecen, 4032
Research Site
Orosháza, 5900
Research Site
Pécs, 7624
About this study
Official title: A Phase IIb, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AZD0780 in Participants With Dyslipidemia
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
- Being tested
- AZD0780, Placebo
- Keywords
- Dyslipidemia,, 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.
AZD0780Drug
AZD0780 administered orally, once daily for 12 weeks
PlaceboDrug
Placebo administered orally, once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | AZD0780, Dose 1 Receives: Drug: AZD0780 |
| Arm B | Experimental | AZD0780, Dose 2 Receives: Drug: AZD0780 |
| Arm C | Experimental | AZD0780, Dose 3 Receives: Drug: AZD0780 |
| Arm D | Experimental | AZD0780, Dose 4 Receives: Drug: AZD0780 |
| Arm E | Placebo comparator | Placebo, matched for appearance Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Total Cholesterol at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Triglycerides at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: 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
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein A1 at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein B at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. 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.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Total Cholesterol at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Triglycerides at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: 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
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein A1 at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein B at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Lipoprotein-a at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of Remnant Cholesterol at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.
Measured: From first day of treatment up to week 12
Percent Change From Baseline of High Sensitivity C-reactive Protein (hsCRP) at Week 12
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.
Measured: From first day of treatment up to week 12
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Geometric mean plasma concentration; LLOQ = 0.01 umol/L; BLQ values are handled as Not Quantified (NQ)
Measured: From week 1 up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start19 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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
- Participants will be randomized with equal distribution across 5 parallel treatment arms to either placebo or one of four AZD0780 doses.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173570
- Sponsor's protocol ID
- D7960C00006
- Other IDs
- 2023-506197-12-00, 2023
- Acronym
- PURSUIT
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2023
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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.
Publications
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.
PubMed 40167413
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AZD0780 in Participants With Dyslipidemia
- ClinicalTrials.gov ID
- NCT06173570
- Acronym / sponsor ID
- PURSUIT / D7960C00006
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemia,, Low-Density Lipoprotein Cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be randomized with equal distribution across 5 parallel treatment arms to either placebo or one of four AZD0780 doses.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AZD0780AZD0780, Dose 1 |
| Arm B | Experimental | Drug: AZD0780AZD0780, Dose 2 |
| Arm C | Experimental | Drug: AZD0780AZD0780, Dose 3 |
| Arm D | Experimental | Drug: AZD0780AZD0780, Dose 4 |
| Arm E | Placebo comparator | Drug: PlaceboPlacebo, matched for appearance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| AZD0780AZD0780 administered orally, once daily for 12 weeks | Drug | Arm A, Arm B, Arm C, Arm D |
| PlaceboPlacebo administered orally, once daily for 12 weeks | Drug | Arm E |
Primary outcome
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12
Time frame: From first day of treatment up 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.
19 secondary outcomes
Percent Change From Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Total Cholesterol at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Triglycerides at Week 12
Time frame: 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
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein A1 at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein B at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Total Cholesterol at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Triglycerides at Week 12
Time frame: 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
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein A1 at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Apolipoprotein B at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Lipoprotein-a at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of Remnant Cholesterol at Week 12
Time frame: From first day of treatment up to week 12
Percent Change From Baseline of High Sensitivity C-reactive Protein (hsCRP) at Week 12
Time frame: From first day of treatment up to week 12
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Time frame: From week 1 up to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40167413Koren 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.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR SynopsisLink 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.
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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.
55 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD0780 in people with Dyslipidemia, run by AstraZeneca at 55 sites in 8 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 6 inclusion and 10 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Czechia, Spain, Slovakia, Canada and 3 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 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?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12 (time frame: From first day of treatment up to week 12). 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 NCT06173570, which also lists 1 linked publication.
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 17 Nov 2025.