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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.

ConditionHypercholesterolaemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Asian origin.

Statin intolerance

Uncontrolled severe hypertension

Uncontrolled type 2 diabetes mellitus

Trial design

Design model

Factorial

Treatments tested in this trial

  • Laroprovstat

    Drug

    daily oral dose of the Laroprovstat

  • Rosuvastatin 1

    Drug

    daily oral dose of the Rosuvastatin 1

  • Rosuvastatin 2

    Drug

    daily oral dose of the Rosuvastatin 2

  • Laroprovstat/Rosuvastatin 1

    Drug

    daily oral dose of the Laroprovstat/Rosuvastatin 1

  • Placebo to match rosuvastatin

    Drug

    daily oral dose of the Placebo to match Rosuvastatin

  • Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

    Drug

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

  • Laroprovstat/Rosuvastatin 2

    Drug

    daily oral dose of the Laroprovstat/Rosuvastatin 2

  • Placebo to match Laroprovstat/Rosuvastatin 2

    Drug

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

Treatment groups

600 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: LaroprovstatActive comparator 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions
Group C: Laroprovstat/Rosuvastatin dose combination 1Experimental treatment 3 interventions
Group D: Laroprovstat/Rosuvastatin dose combination 2Experimental treatment 3 interventions
Group E: Rosuvastatin dose 1Active comparator 3 interventions
Group F: Rosuvastatin dose 2Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Relative change in LDL-C at 8 weeks

To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 2 * Laroprovstat

Time frame
8 weeks
2

Relative change in LDL-C at 8 weeks

To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 1 * Laroprovstat

Time frame
8 weeks

Secondary outcomes

1

Relative change in LDL-C

To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks

Time frame
8 weeks
2

Relative change in Apo B

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks

Time frame
8 weeks
3

Relative change in non-HDL-C

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks

Time frame
8 weeks
4

Relative change in total cholesterol

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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