A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on LDL-C in LLT-naïve Patients
Key facts
- Who runs it
- AstraZeneca
- Where
- Hà Nội, Haiphong, Ho Chi Minh City, Hochiminh, and Hochiminh City, VietnamSee the 5 sitesAlso in 5 other countries, 34 sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 204 people, planned
- Starts
- 21 Dec 2026
- Expected to end
- 11 Oct 2027
- Type of study
- Interventional, 6 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Laroprovstat
- Rosuvastatin 1
- Rosuvastatin 2
- FDC laroprovstat/Rosuvastatin 1
- FDC laroprovstat/Rosuvastatin 2
- Placebo to match rosuvastatin
- Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Participant must be ≥ 18 years of age
- Participants with no clinical history of ASCVD and a 10-year ASCVD risk estimated as low
- Participants who have not received any LLT in the 3 months prior to screening
- Participants of Asian origin
Who cannot take part
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- Statin intolerance
- Inadequately treated hypothyroidism
Where in Vietnam
Also in 5 other countries, 34 sites
- Hà NộiHospital not named in the registryNo longer taking part
- HaiphongHospital not named in the registryNo longer taking part
- Ho Chi Minh CityHospital not named in the registryNo longer taking part
- HochiminhHospital not named in the registryNo longer taking part
- Hochiminh CityHospital not named in the registryNo longer taking part
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients with hypercholesterolaemia. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
The 6 groups in the trial
- LaroprovstatExisting treatment, for comparison
The patient will receive a daily dose of Laroprovstat.
Treatment: Laroprovstat and Placebo to match rosuvastatin
- Rosuvastatin Dose 1Existing treatment, for comparison
The patient will receive a daily dose of Rosuvastatin 1.
Treatment: Rosuvastatin 1 and Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
- Rosuvastatin Dose 2Existing treatment, for comparison
The patient will receive a daily dose of Rosuvastatin 2.
Treatment: Rosuvastatin 2 and Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
- FDC laroprovstat/rosuvastatin Dose combination 1Treatment being tested
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 1.
Treatment: FDC laroprovstat/Rosuvastatin 1 and Placebo to match rosuvastatin
- FDC laroprovstat/rosuvastatin Dose combination 2Treatment being tested
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 2.
Treatment: FDC laroprovstat/Rosuvastatin 2 and Placebo to match rosuvastatin
- PlaceboPlacebo, for comparison
The patient will receive a daily dose of Placebo.
Treatment: Placebo to match rosuvastatin and Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase III, Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients
- Record updated
- 12 November 2026