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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.

NCT07619131

Not Yet RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Hypercholesterolaemia

Interventions: Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, Laroprovstat/Rosuvastatin 1, Placebo to match rosuvastatin

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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