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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 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-06-01

No results posted yet for this study

Summary

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.

Conditions

  • 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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2027-07-30
Completion
2027-07-30
FDA Drug
Yes

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619131 on ClinicalTrials.gov