AZD0780 Clinical Trials

What Is AZD0780?

AZD0780 is an investigational drug currently being studied in clinical trials. It is administered orally, typically as a tablet, and is often taken once daily. The specific mechanism of action for AZD0780 is not detailed in the available trial descriptions, but it is being investigated for its potential to treat various conditions, primarily those related to lipid disorders and cardiovascular health.

Development of AZD0780 is sponsored by AstraZeneca. Clinical research on AZD0780 began with the first trial initiated on May 20, 2022, and the latest trial is expected to conclude on February 20, 2026. To date, 16 clinical trials have been conducted or are ongoing for AZD0780, involving a total of 20,189 participants. Of these, 3 trials are currently recruiting new participants, while 10 trials have been completed.

Uses and Conditions Under Study

AZD0780 is being investigated for its potential to treat several conditions, with a primary focus on lipid disorders and cardiovascular health.

• Lipid Disorders and Cardiovascular Disease: AZD0780 is being studied extensively for conditions such as Dyslipidemia (4 trials), Dyslipidaemia (3 trials), Heterozygous Familial Hypercholesterolaemia (1 trial), Atherosclerotic Cardiovascular Disease (1 trial), Cardiovascular Disease (2 trials), and Cardiovascular Diseases (1 trial). These conditions involve abnormal levels of lipids (fats) in the blood, such as high cholesterol, which can lead to the hardening and narrowing of arteries and increase the risk of heart attacks and strokes. Investigating AZD0780 for these conditions suggests it may play a role in managing cholesterol levels or improving cardiovascular outcomes.
• Healthy Participants: Two trials involving healthy participants are being conducted to assess the drug's safety, how it is absorbed, distributed, metabolized, and excreted by the body (pharmacokinetics), and how it interacts with other medications. These studies are crucial for understanding the drug's profile before wider use in patient populations.
• Specific Patient Populations: AZD0780 is also being studied in patients with Renal Impairment (1 trial) and Hepatic Impairment (1 trial). These trials help determine if the drug's dosage needs to be adjusted for individuals with kidney or liver problems, as these organs play a key role in processing and eliminating medications from the body.

Dosing

AZD0780 is administered orally, primarily in the form of tablets. Clinical trials have explored various dosing strategies, including administration as a daily oral dose, often once daily.

The studies investigate AZD0780 both as a standalone treatment and in combination with other medications. Combinations studied include:

• AZD0780 with Rosuvastatin
• AZD0780 with Metformin
• AZD0780 with Ezetimibe
• AZD0780 with Rosuvastatin and Ezetimibe
• AZD0780 with Bempedoic Acid and Ezetimibe (in an optional cohort)

Clinical trials have explored a range of different doses of AZD0780, referred to as "dose 1" through "dose 11" in various study cohorts. Specific strengths (e.g., in milligrams) are not detailed in the available trial descriptions. Studies also include cohorts investigating potential drug interactions with substances like Itraconazole, Carbamazepine, Midazolam, and combinations of Ethinyl Estradiol (EE) and Levonorgestrel (LNG). The precise dosing regimen and strength for any approved use would be determined based on the full results of these and future studies.

Side Effects

In a clinical trial involving 340 patients treated with AZD0780, the most commonly reported side effect was hypertension (high blood pressure). 3.2% of patients taking AZD0780 experienced hypertension, compared to 5.8% of patients who received a placebo.

Clinical Trial Results

A completed clinical trial, NCT06173570, investigated the efficacy, safety, and tolerability of different doses of AZD0780 in patients with dyslipidemia, a condition characterized by unhealthy levels of cholesterol or fats in the blood.

AZD0780 Plasma Concentrations

The study measured the amount of AZD0780 in the blood (plasma concentrations) at various time points. The average (geometric mean) plasma concentrations increased with higher doses:

• For the 1 mg dose, the average concentration was approximately 0.09 umol/L.
• For the 3 mg dose, the average concentration was approximately 0.24 umol/L.
• For the 10 mg dose, the average concentration was approximately 0.80 umol/L.
• For the 30 mg dose, the average concentration was approximately 2.59 umol/L.

Changes in Cholesterol and Lipid Levels at Week 12

The trial assessed how AZD0780 affected various cholesterol and lipid levels, which are key indicators in dyslipidemia. A decrease in harmful lipids and an increase in beneficial ones are generally considered positive changes.

• Low-Density Lipoprotein Cholesterol (LDL-C): Often called "bad" cholesterol, lower levels are desirable. Patients taking AZD0780 experienced significant reductions in LDL-C from baseline, while those on placebo saw an increase.
  • The 1 mg dose reduced LDL-C by an average of 30.83%.
  • The 3 mg dose reduced LDL-C by an average of 33.59%.
  • The 10 mg dose reduced LDL-C by an average of 40.78%.
  • The 30 mg dose reduced LDL-C by an average of 46.52%.
  • Patients on placebo experienced an average increase of 3.74%.
• Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): This includes all "bad" cholesterol types. Lower levels are desirable.
  • The 1 mg dose reduced Non-HDL-C by an average of 26.49%.
  • The 3 mg dose reduced Non-HDL-C by an average of 29.64%.
  • The 10 mg dose reduced Non-HDL-C by an average of 34.95%.
  • The 30 mg dose reduced Non-HDL-C by an average of 41.50%.
  • Patients on placebo experienced an average increase of 3.20%.
• Apolipoprotein B (ApoB): A protein component of "bad" cholesterol particles; lower levels are desirable.
  • The 1 mg dose reduced ApoB by an average of 23.72%.
  • The 3 mg dose reduced ApoB by an average of 24.96%.
  • The 10 mg dose reduced ApoB by an average of 34.09%.
  • The 30 mg dose reduced ApoB by an average of 36.91%.
  • Patients on placebo experienced an average increase of 2.68%.
• Lipoprotein-a (Lp(a)): An independent risk factor for heart disease; lower levels are desirable.
  • The 1 mg dose reduced Lp(a) by a median of 7.48%.
  • The 3 mg dose reduced Lp(a) by a median of 11.16%.
  • The 10 mg dose reduced Lp(a) by a median of 19.57%.
  • The 30 mg dose reduced Lp(a) by a median of 19.43%.
  • Patients on placebo showed no change (0.00%).
• High Sensitivity C-reactive Protein (hsCRP): A marker of inflammation; lower levels are desirable.
  • The 30 mg dose of AZD0780 reduced hsCRP by a median of 22.22%.
  • Lower doses (1 mg, 3 mg, 10 mg) and placebo showed no change (0.00%).

Currently Recruiting Trials

AZD0780 is currently being investigated in several clinical trials, offering opportunities for patients to contribute to medical research. These studies aim to understand how AZD0780 can help manage various conditions, particularly those related to cholesterol and cardiovascular health. AstraZeneca is the sponsor for these important studies.

One ongoing Phase 2 study, NCT07218900, is investigating the effect of AZD0780 tablets when combined with rosuvastatin tablets. This research focuses on adult Russian participants with dyslipidaemia, aiming to reduce low-density lipoprotein cholesterol (LDL-C) levels. AZD0780 is a small molecule designed to reduce the amount of cholesterol in the body. This trial is seeking to enroll 76 participants.

A larger, pivotal Phase 3 study, NCT07000357, is evaluating AZD0780 as an oral PCSK9 inhibitor. This study compares AZD0780 with a placebo to assess its effectiveness in reducing the risk of major adverse cardiovascular events (MACE-PLUS). It is open to patients with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. This significant trial plans to enroll 15,100 participants.

Another study, NCT06834932, is a combined Phase 2 and Phase 3 trial. It is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and pharmacokinetics of AZD0780. The medication is administered orally for up to 52 weeks to participants with elevated LDL-C. This study consists of two separate parts and aims to enroll 360 participants.

Where to Participate

Clinical trials for AZD0780 are being conducted across a wide geographic area, making participation accessible to many individuals. These studies are active at 1 site across 245 cities in 41 states within the United States.

The top cities with multiple participating sites include:

• Houston, Texas (5)
• Jacksonville, Florida (4)
• Dallas, Texas (3)
• Orlando, Florida (3)
• Knoxville, Tennessee (3)
• Las Vegas, Nevada (3)
• Atlanta, Georgia (3)
• Phoenix, Arizona (3)
• Tucson, Arizona (3)
• Miami, Florida (3)

Eligibility criteria for these trials generally require participants to be between 18 and 80 years of age. All genders are welcome to participate. It is important to note that these studies are not recruiting healthy volunteers or children.

Development Timeline

The journey of AZD0780 began on May 20, 2022, with its first clinical trial. Since then, AstraZeneca has been the sole sponsor, driving the development of this investigational drug through a comprehensive research program. To date, a total of 16 trials have been initiated, involving a substantial enrollment of 20,189 participants.

The development has progressed through various phases, starting with 9 Phase 1 trials to assess initial safety and dosing. This was followed by 3 Phase 2 trials and 1 Phase 2/Phase 3 trial, which started to evaluate efficacy in specific patient populations. Currently, there are 3 Phase 3 trials underway, indicating that AZD0780 is in advanced stages of clinical investigation.

Initially, the research focused on conditions such as IBS-C and hyperphosphatemia. Over time, the scope of investigation expanded significantly to include a broader range of conditions, reflecting a growing understanding of AZD0780's potential. The pipeline now includes studies for healthy participants, cardiovascular disease, atherosclerotic cardiovascular disease, renal impairment, cardiovascular diseases, hepatic impairment, and heterozygous familial hypercholesterolaemia. This ongoing development is marked by the latest trial initiation on February 20, 2026, demonstrating continued commitment to exploring AZD0780's therapeutic applications.