A Phase 3 interventional study of Laroprovstat and Rosuvastatin 1 in Hypercholesterolaemia, sponsored by AstraZeneca. Recruiting at 152 sites in 11 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 600 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The patient will receive a daily dose of Laroprovstat
Drug: Laroprovstat · Drug: Placebo to match rosuvastatin · Drug: Placebo to match Laroprovstat/Rosuvastatin 2
The patient will receive a daily dose of Placebo
Drug: Placebo to match rosuvastatin · Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 · Drug: Placebo to match Laroprovstat/Rosuvastatin 2
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
Drug: Laroprovstat/Rosuvastatin 1 · Drug: Placebo to match rosuvastatin · Drug: Placebo to match Laroprovstat/Rosuvastatin 2
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
Drug: Placebo to match rosuvastatin · Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 · Drug: Laroprovstat/Rosuvastatin 2
The patient will receive a daily dose of Rosuvastatin 1
Drug: Rosuvastatin 1 · Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 · Drug: Placebo to match Laroprovstat/Rosuvastatin 2
The patient will receive a daily dose of Rosuvastatin 2
Drug: Rosuvastatin 2 · Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 · Drug: Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat
daily oral dose of the Rosuvastatin 1
daily oral dose of the Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
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
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
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
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
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
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
Showing the first 100 of 152 sites across 11 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jul 2027, 11 months after the start.
Of 122 industry-sponsored phase 3 interventional studies under Hypercholesterolemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 11 months is below that.
Counting every sponsor, half of 125 studies reached it within 18 months; a quarter within 10 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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