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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, Laroprovstat/Rosuvastatin 1.
- Who it may be relevant to
- Registry conditions: Hypercholesterolaemia. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
Interventions
- Drug Laroprovstat
daily oral dose of the Laroprovstat - Drug Rosuvastatin 1
daily oral dose of the Rosuvastatin 1 - Drug Rosuvastatin 2
daily oral dose of the Rosuvastatin 2 - Drug Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 1 - Drug Placebo to match rosuvastatin
daily oral dose of the Placebo to match Rosuvastatin - Drug Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 - Drug Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 2 - Drug Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Primary outcome measures
- Relative change in LDL-C at 8 weeks [Time frame: 8 weeks]
- Relative change in LDL-C at 8 weeks [Time frame: 8 weeks]
Secondary outcome measures (4)
- Relative change in LDL-C [Time frame: 8 weeks]
- Relative change in Apo B [Time frame: 8 weeks]
- Relative change in non-HDL-C [Time frame: 8 weeks]
- Relative change in total cholesterol [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Participant must be ≥ 18 years of age
- Participants with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low
- Participants who have not received any LLT in the 3 months prior to screening
Exclusion criteria
- Asian origin.
- Statin intolerance
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- Inadequately treated hypothyroidism
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07619131 · D7961C00002 · 2026-525642-30-00