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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.

AstraZeneca · NCT07619131

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–130 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
600
US sites recruiting
8
Study start
August 12, 2026
Record last updated
September 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Laroprovstat; Rosuvastatin 1; Rosuvastatin 2; Laroprovstat/Rosuvastatin 1; Placebo to match rosuvastatin; Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1; Laroprovstat/Rosuvastatin 2; Placebo to match Laroprovstat/Rosuvastatin 2

Conditions: Hypercholesterolaemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • AstraZeneca Clinical Study Information Center · +18772409479 · information.center@astrazeneca.com
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A Phase III Study to Assess the Effect of FDC… (NCT07619131) | Bored Studies