Laroprovstat + Rosuvastatin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new tablet that combines two medications, laroprovstat and rosuvastatin, compared to taking each medication separately. Both medications target cholesterol management, but the trial focuses on healthy adults to assess how the body absorbs the combination. Participants must be healthy, non-smokers, and consume little caffeine, with no major medical issues that could affect drug absorption. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining laroprovstat and rosuvastatin has been tested for safety in earlier studies. In individuals with high cholesterol, this combination effectively lowers LDL cholesterol. Rosuvastatin, a well-known medication for lowering cholesterol, can cause side effects such as headaches, muscle pain, and nausea. Serious side effects are rare but may include muscle and liver problems.
Laroprovstat is newer, and its specific side effects are less well-known. Early trials, including this one, focus on safety and patient tolerance. The treatment undergoes close monitoring to ensure human safety. In these early stages, researchers carefully watch for any side effects. While the side effects of rosuvastatin are known, the combination with laroprovstat is under study to better understand its safety profile.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the potential of the laroprovstat and rosuvastatin combination because it offers a novel approach to managing cholesterol levels. Unlike existing statins, which primarily focus on lowering LDL cholesterol through a single mechanism, this combination leverages laroprovstat, which may provide additional cholesterol-lowering effects by targeting different pathways. The fixed-dose combination delivery method also simplifies the treatment process, potentially boosting patient adherence and improving outcomes. By combining these two agents, the hope is to achieve more comprehensive lipid control, offering a promising alternative to current standard treatments.
What evidence suggests that this trial's treatments could be effective?
Research has shown that combining laroprovstat and rosuvastatin can significantly lower LDL-C, often referred to as "bad cholesterol." Studies indicate that this combination can reduce LDL-C levels by about 70% to 80%. This trial will evaluate different formulations of the laroprovstat and rosuvastatin combination. Laroprovstat helps the body remove more LDL-C from the blood, while rosuvastatin reduces the liver's cholesterol production. Together, they effectively combat high cholesterol.12678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single-dose treatments of laroprovstat and rosuvastatin in various formulations across 3 or 4 periods
Washout
A washout period of 14 days occurs between each treatment period to clear the drugs from the participants' systems
Follow-up
Participants are monitored for pharmacokinetic profiles and safety after the final treatment period
What Are the Treatments Tested in This Trial?
Interventions
- Laroprovstat/Rosuvastatin Fixed-Dose Combination
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin in a fed state.
Participants will receive a single oral Dose X laroprovstat and a single oral Dose 2 rosuvastatin as STP reference formulations following an overnight fast.
Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast.
Participants will receive a single oral FCDP test formulation 1 of Dose X laroprovstat/Dose 2 rosuvastatin following an overnight fast.
Participants will receive a single oral Dose X laroprovstat and a single oral Dose 1 rosuvastatin as Single Therapy Product (STP) reference formulations following an overnight fast.
Participants will receive a single oral FCDP test formulation 2 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast.
Participants will receive a single oral Fixed Combination Drug Product (FCDP) test formulation 1 of Dose X laroprovstat/Dose 1 rosuvastatin following an overnight fast.
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
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
Abstract 4359604: Model-Based Evaluation of LDL-C ...
The combination of rosuvastatin 20 mg and laroprovstat 30 mg resulted in a predicted mean LDL-C reduction of –76% (95% CI: –86% to –62%) at Week ...
NCT07316608 | A Phase I, Open-label, Crossover Study ...
The purpose of this study is to assess how well laroprovstat and rosuvastatin combined in a single tablet to be taken by mouth works compared with ...
Abstract 4364312: Laroprovstat (AZD0780) an oral, small ...
Combined rosuvastatin and laroprovstat treatment resulted in a total approximate reduction in LDL-C of 70% and 80% for laroprovstat 1 mg and 30 ...
laroprovstat (AZD0780) News
Laroprovstat (AZD0780) an oral, small molecule PCSK9 inhibitor demonstrates improvements in the lipid profile in participants with hypercholesterolemia: Results ...
Choosing the Right Non-Statin Therapy for the Right Patient
In early-phase trials, once-daily oral muvalaplin achieved up to 65–85% reductions in Lp(a) levels with good tolerability [69]. An outcomes ...
Rosuvastatin: Side Effects, Dosage, Uses, and More
More common side effects of rosuvastatin include headache, muscle pain, and nausea. Serious side effects, including severe muscle problems and liver damage, may ...
Rosuvastatin: An Independent Analysis of Risks and Benefits
We conclude that rosuvastatin at approved doses incurs no greater risk for adverse events than other marketed statins, except for a mild form of tubular ...
laroprovstat (AZD0780) / AstraZeneca
Pharmacological management of elevated LDL in patients with hypercholesterolaemia and mixed dyslipidaemia. (PubMed, Expert Opin Pharmacother) - "Ezetimibe ...
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