Recruiting at 12 sites Phase 3 Hypercholesterolaemia

Trial comparing treatments for Hypercholesterolaemia

Official title 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.

ClinicalTrials.gov ID: NCT07619131

What this study is testing

What is Laroprovstat?

an investigational oral medicine being studied as a potential treatment for hypercholesterolaemia

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to see how the combined pill changes LDL‑C (bad cholesterol) levels and whether it is safe and well‑tolerated.
Who it's for
Adults with high cholesterol who have not previously taken any lipid‑lowering therapy.
What's involved
Participants will be randomly assigned to take the combined pill, laroprovstat alone, rosuvastatin alone, or a placebo, with blood tests to measure cholesterol and monitor safety.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 130

You may be able to join if

  • 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

You likely can't join if

  • Asian origin.
  • Statin intolerance
  • Uncontrolled severe hypertension
  • Uncontrolled type 2 diabetes mellitus
  • Inadequately treated hypothyroidism

The study team makes the final eligibility decision.

Where it is enrolling

  • Colorado Springs, Colorado, United States
  • Lakeland, Florida, United States
  • Conyers, Georgia, United States
  • Hinesville, Georgia, United States
  • Lexington, Kentucky, United States
  • Millville, New Jersey, United States
  • Salt Lake City, Utah, United States
  • South Jordan, Utah, United States
  • Hamilton, Ontario, Canada
  • Scarborough Village, Ontario, Canada
  • Stouffville, Ontario, Canada
  • Sherbrooke, Quebec, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Colorado Springs, Colorado, United States; Lakeland, Florida, United States; Conyers, Georgia, United States; Hinesville, Georgia, United States; Lexington, Kentucky, United States; Millville, New Jersey, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.