AZD0780 + AZD4954 for Healthy Subjects
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.12345Why 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single dose of either AZD4954 or laroprovstat alone
Treatment Period 2
Participants receive single doses of laroprovstat + AZD4954
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C).
Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C).
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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.
2.
trial.medpath.com
trial.medpath.com/clinical-trial/56f9254909b78f77/nct06980428-azd4954-safety-pharmacokinetics-healthy-dyslipidemiaA Study to Investigate Safety, Tolerability, Pharmacokinetics ...
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated ...
3.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/34005554/astrazenecas-phase-i-study-on-azd4954-a-potential-game-changer-in-cardiovascular-treatment/AstraZeneca's Phase I Study on AZD4954: A Potential ...
' The study aims to evaluate the safety and effectiveness of AZD4954 in healthy adults, focusing on those with varying levels of Lipoprotein(a), ...
4.
tipranks.com
tipranks.com/news/company-announcements/astrazenecas-new-study-on-azd4954-potential-breakthrough-in-cardiovascular-treatmentAstraZeneca's New Study on AZD4954: Potential ...
The study aims to evaluate the safety and effectiveness of AZD4954, a new drug intended to address elevated Lipoprotein(a) levels, which are ...
A Study to Assess the Effect of AZD0780 ...
The purpose this study is to measure the impact of laroprovstat (AZD0780) on the pharmacokinetics (PK) of AZD4954 and the impact of AZD4954 on ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd4954-in-heA Study to Investigate Safety, Tolerability, Pharmacokinetics ...
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of ...
7.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/33515115/astrazenecas-new-study-on-azd4954-potential-breakthrough-in-cardiovascular-treatment/AstraZeneca's New Study on AZD4954
The study aims to evaluate the safety and effectiveness of AZD4954, a new drug intended to address elevated Lipoprotein(a) levels, which are linked to ...
8.
tipranks.com
tipranks.com/news/company-announcements/astrazenecas-new-study-on-azd4954-a-potential-game-changer-in-cardiovascular-treatmentAstraZeneca's New Study on AZD4954: A Potential Game ...
The study aims to evaluate the safety and effectiveness of AZD4954, a new drug targeting elevated Lipoprotein(a) levels, which are linked to ...
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