Recruiting
Phase 3

FDC Laroprovstat/Rosuvastatin

Sponsor:

AstraZeneca

Code:

NCT07619131

Conditions

Hypercholesterolaemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Laroprovstat

Rosuvastatin 1

Rosuvastatin 2

Laroprovstat/Rosuvastatin 1

Placebo to match rosuvastatin

Study Details

Brief 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

Study ID

NCT07619131

Start date

Aug 12, 2026

Status verified date

Sep, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Laroprovstat

The patient will receive a daily dose of Laroprovstat

placebo comparator: Placebo

The patient will receive a daily dose of Placebo

experimental: Laroprovstat/Rosuvastatin dose combination 1

The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1

experimental: Laroprovstat/Rosuvastatin dose combination 2

The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2

active comparator: Rosuvastatin dose 1

The patient will receive a daily dose of Rosuvastatin 1

active comparator: Rosuvastatin dose 2

The patient will receive a daily dose of Rosuvastatin 2

Interventions

Laroprovstat

daily oral dose of the Laroprovstat

Rosuvastatin 1

daily oral dose of the Rosuvastatin 1

Rosuvastatin 2

daily oral dose of the Rosuvastatin 2

Laroprovstat/Rosuvastatin 1

daily oral dose of the Laroprovstat/Rosuvastatin 1

Placebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin

Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

Laroprovstat/Rosuvastatin 2

daily oral dose of the Laroprovstat/Rosuvastatin 2

Placebo to match Laroprovstat/Rosuvastatin 2

daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2

Primary outcome measure

  • Relative change in LDL-C at 8 weeks [ Time Frame: 8 weeks ]
  • Relative change in LDL-C at 8 weeks [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

+18772409479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Colorado Springs, Colorado, United States, 80909

Research Site

Recruiting

Lakeland, Florida, United States, 33813

Research Site

Recruiting

Conyers, Georgia, United States, 30094

Research Site

Recruiting

Hinesville, Georgia, United States, 31313

Research Site

Recruiting

Lexington, Kentucky, United States, 40503

Research Site

Recruiting

Millville, New Jersey, United States, 08332

Research Site

Recruiting

Salt Lake City, Utah, United States, 84109

Research Site

Recruiting

South Jordan, Utah, United States, 84095

Research Site

Recruiting

Hamilton, Ontario, Canada, L8L 5G4

Research Site

Recruiting

Scarborough Village, Ontario, Canada, M1R 0B1

Research Site

Recruiting

Stouffville, Ontario, Canada, L4A1H2

Research Site

Recruiting

Sherbrooke, Quebec, Canada, J1J 2G2

More Information

Sponsor

AstraZeneca

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-10.