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AZD0780 + AZD4954 for Healthy Subjects

AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the interaction between two experimental drugs, AZD0780 (laroprovstat) and AZD4954, in the body. Researchers test how each drug affects the other's absorption and processing when taken alone and together. Healthy men and women with a body mass index (BMI) between 18 and 35 and a minimum weight of 50 kg may qualify for this study. Participants must not have any health conditions, such as liver or kidney disease, that could affect drug processing. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken any lipid-lowering therapy or laroprovstat in the 3 months before the screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies tested AZD4954 to assess its safety and tolerability. These studies examined the drug's mechanism in the body and its effects. Results indicated that AZD4954 was generally well-tolerated, with mild to moderate side effects. Common side effects included headaches and dizziness, but these were not severe.

AZD0780 is currently undergoing a Phase 1 trial, where researchers primarily assess its safety. This phase marks the first testing of a new treatment in humans, so data may be limited. However, if AZD0780 had shown serious safety issues in earlier tests, it would not have progressed to this phase.

Overall, existing research suggests AZD4954 is safe for most people, while AZD0780 is still under safety evaluation in humans. Participants can expect careful monitoring of side effects during the trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments AZD0780 and AZD4954 because they offer a new approach to addressing health conditions. Unlike many existing treatments that focus on symptom management, AZD0780 and AZD4954 have the potential to work by directly targeting the underlying causes of diseases. AZD4954, when combined with laroprovstat, might represent a new mechanism of action, providing a more targeted therapy. This could mean more effective results with possibly fewer side effects, which is a significant improvement over current options.

What evidence suggests that this trial's treatments could be effective?

Research has shown that AZD4954 may help lower cholesterol by affecting its production in the body. This could benefit individuals with high levels of Lipoprotein(a), which is linked to heart disease. Studies have found AZD4954 effective in healthy adults, particularly those with elevated Lipoprotein(a). In this trial, participants in Cohort 1 will receive AZD4954 alone, followed by a combination of laroprovstat (AZD0780) and AZD4954. Cohort 2 will receive laroprovstat alone, followed by the same combination. Researchers are studying laroprovstat to understand its interaction with AZD4954, although specific data on its effectiveness alone is not yet available. The combination of these treatments is being explored to understand their synergistic effects in the body.23678

Are You a Good Fit for This Trial?

This trial is for healthy adults (men and women) aged 18 or older, with a BMI between 18 and 35, weighing at least 50 kg. Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing age. Men with partners who could become pregnant must also use contraception.

Inclusion Criteria

* Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
I am not breastfeeding and will use effective birth control if I could become pregnant.
I am a woman who is postmenopausal or permanently sterile from surgery (not tubal ligation).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive a single dose of either AZD4954 or laroprovstat alone

1 week
1 visit (in-person)

Treatment Period 2

Participants receive single doses of laroprovstat + AZD4954

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 weeks
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • AZD0780
  • AZD4954

Trial Overview

The study tests how two drugs—laroprovstat (AZD0780) and AZD4954—affect each other's levels in the body when taken together by healthy volunteers. Participants receive both drugs to see if one changes how the other is processed.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort 2: Treatment Sequence BCExperimental Treatment2 Interventions
Group II: Cohort 1: Treatment Sequence ACExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

AZD4954 for Healthy Subjects

Animal studies found that this drug effectively reduces these cholesterol levels by affecting certain processes in the body that control cholesterol production.

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