A Phase 3 interventional study of Laroprovstat and Rosuvastatin 1 in Hypercholesterolemia, sponsored by AstraZeneca. Not yet recruiting at 42 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
Among 60 studies in Hypercholesterolemia by AstraZeneca — 3 open to participants now, 3 under way, 3 of them phase 3. Hypercholesterolemia · AstraZeneca.
Among the 60 studies in Hypercholesterolemia by AstraZeneca, this one is the 24th largest by planned enrollment of the 33 interventional ones that give a count, is one of 4 that started in 2026, is one of 25 in phase 3, and was the 60th registered.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
Browse Hypercholesterolemia studies →3 of the 60 studies in Hypercholesterolemia by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Australia, Canada and 1 more country
Ages 18–130
AstraZeneca · Sites in United States, Bulgaria, Canada and 8 more countries
Ages 18–130
By country, each count listing its studies:
Of the 55 Hypercholesterolemia studies recruiting now, 23 (42%) set no upper age limit and 20 (36%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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60 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 204 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Median enrollment 840 across the 33 interventional studies, 1,491 across the 24 observational. Of the 55 that completed or were terminated, 7 (13%) have results posted.
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AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
3 of the studies in Hypercholesterolemia by AstraZeneca that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07619118Phase 3AstraZenecaA Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia | 2027-05-28 |
| NCT07619131Phase 3AstraZenecaA Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients. | 2027-07-30 |
| NCT07930507Phase 3AstraZenecaA Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on LDL-C in LLT-naïve Patients | 2027-10-11 |
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Among the 60 studies in Hypercholesterolemia by AstraZeneca, from their registry updates:
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The purpose of this study is to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients with hypercholesterolaemia. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
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
The patient will receive a daily dose of Rosuvastatin 1.
Drug: Rosuvastatin 1 · Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
The patient will receive a daily dose of Rosuvastatin 2.
Drug: Rosuvastatin 2 · Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 1.
Drug: FDC laroprovstat/Rosuvastatin 1 · Drug: Placebo to match rosuvastatin
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 2.
Drug: FDC laroprovstat/Rosuvastatin 2 · Drug: Placebo to match rosuvastatin
The patient will receive a daily dose of Placebo.
Drug: Placebo to match rosuvastatin · Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
daily oral dose of the Laroprovstat
daily oral dose of the Rosuvastatin 1
Also known as: Crestor
daily oral dose of the Rosuvastatin 2
daily oral dose of the FDC Laroprovstat/Rosuvastatin 1
daily oral dose of the FDC Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
Relative change in LDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 2 versus placebo, rosuvastatin Dose 2, and laroprovstat on LDL-C at Week 8.
Time frame: Week 8
Relative change in LDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 1 versus placebo, rosuvastatin Dose 1, and laroprovstat on LDL-C at Week 8.
Time frame: Week 8
Relative change in Apo B
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on Apo B at Week 8.
Time frame: Week 8
Relative change in non-HDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-HDL-C at Week 8.
Time frame: Week 8
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 Week 8.
Time frame: Week 8
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.
Start is estimated for Dec 2026; primary completion for Oct 2027, 9 months later.
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 9 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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