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New Cholesterol-Lowering pill shows promise in Mid-Stage trial
NCT ID NCT06173570
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new daily medication called AZD0780 in 428 adults with dyslipidemia (abnormal cholesterol levels). Participants took one of several doses of AZD0780 or a placebo for 12 weeks. The main goal was to see how much the drug lowered LDL (bad) cholesterol compared to placebo. The trial also checked safety and how the drug levels changed in the blood. Results showed that AZD0780 effectively reduced LDL cholesterol in a dose-dependent manner.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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428 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Huntsville, Alabama, 35801, United States
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Research Site
Lincoln, California, 95648, United States
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Research Site
Palm Springs, California, 92262, United States
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Research Site
Santa Ana, California, 92704, United States
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Research Site
Boca Raton, Florida, 33434, United States
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Research Site
Hialeah, Florida, 33012, United States
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Research Site
Inverness, Florida, 34452, United States
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Research Site
Jacksonville, Florida, 32216, United States
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Indianapolis, Indiana, 46260, United States
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Research Site
Louisville, Kentucky, 40213, United States
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Research Site
New Windsor, New York, 12553, United States
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Research Site
Greensboro, North Carolina, 27408, United States
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Fargo, North Dakota, 58104, United States
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Research Site
San Marcos, Texas, 78666, United States
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Research Site
Barrie, Ontario, L4N 7L3, Canada
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Research Site
Brampton, Ontario, L6S 0C6, Canada
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Research Site
Cambridge, Ontario, N1R 6V6, Canada
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Concord, Ontario, L4K 4M2, Canada
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Research Site
Guelph, Ontario, N1H 1B1, Canada
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Research Site
Toronto, Ontario, M6G 1M2, Canada
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Research Site
Benešov, 256 01, Czechia
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Research Site
Brandýs nad Labem, 250 01, Czechia
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Research Site
Brno, 603 00, Czechia
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Research Site
Louny, 440 01, Czechia
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Research Site
Náchod, 547 01, Czechia
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Research Site
Prague, 150 00, Czechia
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Research Site
Příbram, 261 01, Czechia
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Research Site
Teplice, 415 01, Czechia
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Research Site
Uherské Hradiště, 68601, Czechia
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Research Site
Aarhus, 8200, Denmark
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Research Site
Herning, 7400, Denmark
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Research Site
Hvidovre, 2650, Denmark
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Research Site
Svendborg, 5700, Denmark
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Research Site
Viborg, 8800, Denmark
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Research Site
Budapest, 1027, Hungary
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Research Site
Debrecen, 4032, Hungary
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Research Site
Orosháza, 5900, Hungary
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Research Site
Pécs, 7624, Hungary
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Research Site
Chūōku, 103-0027, Japan
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Research Site
Itabashi-ku, 173-0004, Japan
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Research Site
Bratislava, 831 03, Slovakia
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Research Site
Brezno, 977 01, Slovakia
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Research Site
Lučenec, 984 01, Slovakia
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Research Site
Prešov, 080 01, Slovakia
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Research Site
Rožňava, 048 01, Slovakia
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Research Site
Svidník, 08901, Slovakia
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Research Site
Trebišov, 075 01, Slovakia
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Research Site
A Coruña, 15006, Spain
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Research Site
Barcelona, 08041, Spain
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Research Site
Córdoba, 14004, Spain
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Research Site
Ferrol, 15405, Spain
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Research Site
Santiago(A Coruña), 15706, Spain
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Research Site
Seville, 41004, Spain
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Research Site
Seville, 41013, Spain
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Research Site
Seville, 41071, Spain
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