HypercholesterolaemiaPhase 3NCT07619118
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
A Phase 3 study testing laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2 and laroprovstat/rosuvastatin 3 in people with Hypercholesterolaemia, run by AstraZeneca at 45 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2 and laroprovstat/rosuvastatin 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 45 sitesin 4 countries
- Study dates
- 10 Sep 2026to 28 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 18 years of age
- Participants must be on a stable dose of all background LLTs
- The stable statin dose should be judged as their maximally tolerated dose
- Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event
Who cannot join
- Asian origin
- Uncontrolled severe hypertension
- Uncontrolled T2DM
- Inadequately treated hypothyroidism
Trial locations and contacts
45 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
45 sites in 4 countries
United States26 sites, 25 recruiting
- Not yet recruiting
Research Site
Anderson, South Carolina, 29621
- Recruiting
Research Site
Beltsville, Maryland, 20705
- Not yet recruiting
Research Site
Bristol, Tennessee, 37620
- Recruiting
Research Site
Conyers, Georgia, 30094
- Recruiting
Research Site
Decatur, Georgia, 30030
- Not yet recruiting
Research Site
Evansville, Indiana, 47714
- Not yet recruiting
Research Site
Fargo, North Dakota, 58104
- Not yet recruiting
Research Site
Gardena, California, 90247
- Not yet recruiting
Research Site
Houston, Texas, 77002
- Recruiting
Research Site
Houston, Texas, 77040
- Withdrawn
Research Site
Indianapolis, Indiana, 46260
- Not yet recruiting
Research Site
Jacksonville, Florida, 32216
- Not yet recruiting
Research Site
Lomita, California, 90717
- Recruiting
Research Site
Mesquite, Texas, 75149
- Recruiting
Research Site
Miami Lakes, Florida, 33016
- Not yet recruiting
Research Site
Orlando, Florida, 32807
- Not yet recruiting
Research Site
Peachtree Corners, Georgia, 30092
- Not yet recruiting
Research Site
Pembroke Pines, Florida, 33029
- Recruiting
Research Site
Pomona, California, 91768
- Not yet recruiting
Research Site
Rocky Mount, North Carolina, 27804
- Not yet recruiting
Research Site
Sacramento, California, 95821
- Not yet recruiting
Research Site
Statesville, North Carolina, 28625
- Recruiting
Research Site
Sugar Land, Texas, 77478
- Recruiting
Research Site
Sun City West, Arizona, 85375
- Not yet recruiting
Research Site
Wilmington, North Carolina, 28401
- Not yet recruiting
Research Site
Zachary, Louisiana, 70791
Germany9 sites, 9 recruiting
- Not yet recruiting
Research Site
Berlin, 10117
- Not yet recruiting
Research Site
Essen, 45355
- Not yet recruiting
Research Site
Frankfurt, 60596
- Not yet recruiting
Research Site
Freiburg im Breisgau, 79106
- Not yet recruiting
Research Site
Hanover, 30159
- Not yet recruiting
Research Site
Kaiserslautern, 67655
- Not yet recruiting
Research Site
Leipzig, 04103
- Not yet recruiting
Research Site
Munich, 80809
- Not yet recruiting
Research Site
Nuremberg, 90402
Canada6 sites, 5 recruiting
- Suspended
Research Site
Cambridge, Ontario, N1R 6V6
- Recruiting
Research Site
Guelph, Ontario, N1H 1B1
- Recruiting
Research Site
Mississauga, Ontario, L5K2L3
- Recruiting
Research Site
North York, Ontario, M9N 1W4
- Recruiting
Research Site
Stoney Creek, Ontario, L8J 3W2
- Recruiting
Research Site
Toronto, Ontario, M6G 1M2
Australia4 sites, 4 recruiting
- Not yet recruiting
Research Site
Burwood, 2134
- Recruiting
Research Site
Hope Island, 4212
- Not yet recruiting
Research Site
Hoppers Crossing, 3029
- Recruiting
Research Site
Woolloongabba, 4102
About this study
Official title: A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.
- Conditions
- Hypercholesterolaemia
- Being tested
- laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2, laroprovstat/rosuvastatin 3, laroprovstat/rosuvastatin 4, Placebo to match laroprovstat/rosuvastatin 1,2,3
- Keywords
- Hypercholesterolaemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laroprovstat/rosuvastatin 1Combination product
daily oral dose of the laroprovstat/rosuvastatin 1
laroprovstat/rosuvastatin 2Combination product
daily oral dose of the laroprovstat/rosuvastatin 2
laroprovstat/rosuvastatin 3Combination product
daily oral dose of the laroprovstat/rosuvastatin 3
laroprovstat/rosuvastatin 4Combination product
daily oral dose of the laroprovstat/rosuvastatin 4
Placebo to match laroprovstat/rosuvastatin 1,2,3Drug
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
Placebo to match laroprovstat/rosuvastatin 4Drug
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
Rosuvastatin 1Drug
daily oral dose of rosuvastatin 1
Rosuvastatin 2Drug
daily oral dose of rosuvastatin 2
Rosuvastatin 3Drug
daily oral dose of rosuvastatin 3
Rosuvastatin 4Drug
daily oral dose of rosuvastatin 4
Placebo to match RosuvastatinDrug
daily oral dose of placebo to match rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| laroprovstat/rosuvastatin dose 1 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1 Receives: Combination Product: laroprovstat/rosuvastatin 1; Drug: Placebo to match Rosuvastatin |
| rosuvastatin dose 1 | Active comparator | Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1 Receives: Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3; Drug: Rosuvastatin 1 |
| laroprovstat/rosuvastatin dose 2 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2 Receives: Combination Product: laroprovstat/rosuvastatin 2; Drug: Placebo to match Rosuvastatin |
| rosuvastatin dose 2 | Active comparator | Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2 Receives: Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3; Drug: Rosuvastatin 2 |
| laroprovstat/rosuvastatin dose 3 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3 Receives: Combination Product: laroprovstat/rosuvastatin 3; Drug: Placebo to match Rosuvastatin |
| rosuvastatin dose 3 | Active comparator | Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3 Receives: Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3; Drug: Rosuvastatin 3 |
| laroprovstat/rosuvastatin dose 4 | Experimental | Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4 Receives: Combination Product: laroprovstat/rosuvastatin 4; Drug: Placebo to match Rosuvastatin |
| rosuvastatin dose 4 | Active comparator | Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4 Receives: Drug: Placebo to match laroprovstat/rosuvastatin 4; Drug: Rosuvastatin 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in LDL-C at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
Measured: 8 weeks
Secondary outcomes (3)
Relative change in Apo B at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks
Measured: 8 weeks
Relative change in non-HDL-C at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks
Measured: 8 weeks
Relative change in total cholesterol at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start10 Sep 2026
- Primary completion28 May 2027 (estimated)
- Study completion28 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619118
- Sponsor's protocol ID
- D7961C00001
- Other IDs
- 2026-526258-15-00
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia
- ClinicalTrials.gov ID
- NCT07619118
- Acronym / sponsor ID
- D7961C00001
- Conditions
- Hypercholesterolaemia
- Keywords
- Hypercholesterolaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 28 May 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| laroprovstat/rosuvastatin dose 1 | Experimental | Combination Product: laroprovstat/rosuvastatin 1, Drug: Placebo to match RosuvastatinPatient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1 |
| rosuvastatin dose 1 | Active comparator | Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3, Drug: Rosuvastatin 1Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1 |
| laroprovstat/rosuvastatin dose 2 | Experimental | Combination Product: laroprovstat/rosuvastatin 2, Drug: Placebo to match RosuvastatinPatient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2 |
| rosuvastatin dose 2 | Active comparator | Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3, Drug: Rosuvastatin 2Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2 |
| laroprovstat/rosuvastatin dose 3 | Experimental | Combination Product: laroprovstat/rosuvastatin 3, Drug: Placebo to match RosuvastatinPatient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3 |
| rosuvastatin dose 3 | Active comparator | Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3, Drug: Rosuvastatin 3Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3 |
| laroprovstat/rosuvastatin dose 4 | Experimental | Combination Product: laroprovstat/rosuvastatin 4, Drug: Placebo to match RosuvastatinPatient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4 |
| rosuvastatin dose 4 | Active comparator | Drug: Placebo to match laroprovstat/rosuvastatin 4, Drug: Rosuvastatin 4Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be ≥ 18 years of age
- Participants must be on a stable dose of all background LLTs
- The stable statin dose should be judged as their maximally tolerated dose
- Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event
Key exclusion criteria (4 listed)
- Asian origin
- Uncontrolled severe hypertension
- Uncontrolled T2DM
- Inadequately treated hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laroprovstat/rosuvastatin 1daily oral dose of the laroprovstat/rosuvastatin 1 | Combination product | laroprovstat/rosuvastatin dose 1 |
| laroprovstat/rosuvastatin 2daily oral dose of the laroprovstat/rosuvastatin 2 | Combination product | laroprovstat/rosuvastatin dose 2 |
| laroprovstat/rosuvastatin 3daily oral dose of the laroprovstat/rosuvastatin 3 | Combination product | laroprovstat/rosuvastatin dose 3 |
| laroprovstat/rosuvastatin 4daily oral dose of the laroprovstat/rosuvastatin 4 | Combination product | laroprovstat/rosuvastatin dose 4 |
| Placebo to match laroprovstat/rosuvastatin 1,2,3Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 | Drug | rosuvastatin dose 1, rosuvastatin dose 2, rosuvastatin dose 3 |
| Placebo to match laroprovstat/rosuvastatin 4Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4 | Drug | rosuvastatin dose 4 |
| Rosuvastatin 1daily oral dose of rosuvastatin 1 | Drug | rosuvastatin dose 1 |
| Rosuvastatin 2daily oral dose of rosuvastatin 2 | Drug | rosuvastatin dose 2 |
| Rosuvastatin 3daily oral dose of rosuvastatin 3 | Drug | rosuvastatin dose 3 |
| Rosuvastatin 4daily oral dose of rosuvastatin 4 | Drug | rosuvastatin dose 4 |
| Placebo to match Rosuvastatindaily oral dose of placebo to match rosuvastatin | Drug | laroprovstat/rosuvastatin dose 1, laroprovstat/rosuvastatin dose 2, laroprovstat/rosuvastatin dose 3, laroprovstat/rosuvastatin dose 4 |
Primary outcome
Relative change in LDL-C at 8 weeks
Time frame: 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
3 secondary outcomes
Relative change in Apo B at 8 weeks
Time frame: 8 weeks
Relative change in non-HDL-C at 8 weeks
Time frame: 8 weeks
Relative change in total cholesterol at 8 weeks
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
45 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2 and laroprovstat/rosuvastatin 3 in people with Hypercholesterolaemia, run by AstraZeneca at 45 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Germany, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in LDL-C at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.