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.
September 7, 2026 updated by: AstraZeneca
A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: +18772409479
- Email: information.center@astrazeneca.com
Study Locations
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Burgas, Bulgaria, 8000
- Not yet recruiting
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Plovdiv, Bulgaria, 4002
- Not yet recruiting
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Razgrad, Bulgaria, 7200
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Sevlievo, Bulgaria, 5400
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Sofia, Bulgaria, 1202
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1527
- Not yet recruiting
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Varna, Bulgaria, 9010
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Veliko Tarnovo, Bulgaria, 5006
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Ontario
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Hamilton, Ontario, Canada, L8L 5G4
- Recruiting
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Scarborough Village, Ontario, Canada, M1R 0B1
- Recruiting
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Stouffville, Ontario, Canada, L4A1H2
- Recruiting
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
- Not yet recruiting
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Sherbrooke, Quebec, Canada, J1J 2G2
- Recruiting
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Victoriaville, Quebec, Canada, G6P 3Z8
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Aarhus, Denmark, 8200
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Copenhagen, Denmark, 2400
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Gandrup, Denmark, 9362
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Herlev, Denmark, 2730
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Herning, Denmark, 7400
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Svendborg, Denmark, 5700
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Vejle, Denmark, 7100
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Viborg, Denmark, 8800
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Ahrensburg, Germany, 22926
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Berlin, Germany, 10787
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Bochum, Germany, 44789
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Gladbeck, Germany, 45968
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Hamburg, Germany, 20095
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Hanover, Germany, 30449
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Karlsruhe, Germany, 76137
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Leipzig, Germany, 04177
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Löhne, Germany, 32584
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Magdeburg, Germany, 39110
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Obertshausen, Germany, 63179
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Wiesbaden, Germany, 65189
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Budapest, Hungary, 1027
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Budapest, Hungary, 1036
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Budapest, Hungary, 1138
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Kaposvár, Hungary, 7400
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Zalaegerszeg, Hungary, 8900
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Haifa, Israel, 3109601
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Jerusalem, Israel, 9103102
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 4428164
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Petah Tikva, Israel, 49100
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Częstochowa, Poland, 42-217
- Not yet recruiting
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Gdynia, Poland, 81-384
- Suspended
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Katowice, Poland, 40-772
- Not yet recruiting
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Lodz, Poland, 93-338
- Not yet recruiting
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Lodz, Poland, 91-363
- Suspended
- Research Site
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Lublin, Poland, 20-718
- Not yet recruiting
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Lublin, Poland, 20-011
- Not yet recruiting
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Warsaw, Poland, 02-758
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Warsaw, Poland, 00-719
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Barcelona, Spain, 08025
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Barcelona, Spain, 08540
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Barcelona, Spain, 08902
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Figueres, Spain, 17600
- Not yet recruiting
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La Roca del Vallès, Spain, 08430
- Not yet recruiting
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Mataró, Spain, 08303
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Viladecans, Spain, 08840
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Ivano-Frankivsk, Ukraine, 76018
- Not yet recruiting
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Kyiv, Ukraine, 02002
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Kyiv, Ukraine, 03037
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Kyiv, Ukraine, 04210
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Kyiv, Ukraine, 03049
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Kyiv, Ukraine, 04114
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Lviv, Ukraine, 79016
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Uzhhorod, Ukraine, 88014
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Coventry, United Kingdom, CV3 4FJ
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Knutsford, United Kingdom, WA16 9DX
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London, United Kingdom, W6 7HY
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Orpington, United Kingdom, BR5 3QG
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Poole, United Kingdom, BH14 8EE
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Shipley, United Kingdom, BD18 3SA
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Alabama
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Dothan, Alabama, United States, 36305
- Not yet recruiting
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Arizona
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Chandler, Arizona, United States, 85225
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Phoenix, Arizona, United States, 85053
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California
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Huntington Beach, California, United States, 92647
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Loma Linda, California, United States, 92354
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Lomita, California, United States, 90717
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Long Beach, California, United States, 90815
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San Dimas, California, United States, 91773
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Colorado
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Arvada, Colorado, United States, 80002
- Not yet recruiting
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Colorado Springs, Colorado, United States, 80909
- Recruiting
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Not yet recruiting
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Florida
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Clearwater, Florida, United States, 33765
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DeLand, Florida, United States, 32720
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32209
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Lakeland, Florida, United States, 33813
- Recruiting
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Miami Lakes, Florida, United States, 33016
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Ocoee, Florida, United States, 34761
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Plantation, Florida, United States, 33324
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Port Orange, Florida, United States, 32127
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Tampa, Florida, United States, 33606
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Georgia
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Atlanta, Georgia, United States, 30303
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Conyers, Georgia, United States, 30094
- Recruiting
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Decatur, Georgia, United States, 30030
- Not yet recruiting
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Hinesville, Georgia, United States, 31313
- Recruiting
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Peachtree Corners, Georgia, United States, 30092
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Illinois
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Champaign, Illinois, United States, 61822
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 60640
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Island Lake, Illinois, United States, 60042
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Melrose Park, Illinois, United States, 60160
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Palos Hills, Illinois, United States, 60465
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Indiana
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Evansville, Indiana, United States, 47714
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Iowa
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Waterloo, Iowa, United States, 50701
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Kansas
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Derby, Kansas, United States, 67037
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Kentucky
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Lexington, Kentucky, United States, 40503
- Recruiting
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Louisville, Kentucky, United States, 40205
- Not yet recruiting
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Louisiana
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Zachary, Louisiana, United States, 70791
- Not yet recruiting
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Maryland
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Annapolis, Maryland, United States, 21401
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Beltsville, Maryland, United States, 20705
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Bowie, Maryland, United States, 20715
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Lutherville-Timonium, Maryland, United States, 21093
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Oxon Hill, Maryland, United States, 20745
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Michigan
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Flint, Michigan, United States, 48503
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Troy, Michigan, United States, 48098
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Missouri
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Kansas City, Missouri, United States, 64108
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St Louis, Missouri, United States, 63110
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St Louis, Missouri, United States, 63136
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New Jersey
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Millville, New Jersey, United States, 08332
- Recruiting
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New York
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Astoria, New York, United States, 11106
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Brooklyn, New York, United States, 11201
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Brooklyn, New York, United States, 11220
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The Bronx, New York, United States, 10455
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North Carolina
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Durham, North Carolina, United States, 27705
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Morehead City, North Carolina, United States, 28557
- Not yet recruiting
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Statesville, North Carolina, United States, 28625
- Not yet recruiting
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27157
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Ohio
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Columbus, Ohio, United States, 43213
- Not yet recruiting
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Dayton, Ohio, United States, 45424
- Not yet recruiting
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Oklahoma
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Tulsa, Oklahoma, United States, 74137
- Not yet recruiting
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Oregon
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Portland, Oregon, United States, 97223
- Not yet recruiting
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Pennsylvania
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Newport, Pennsylvania, United States, 17074
- Not yet recruiting
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Smithfield, Pennsylvania, United States, 15478
- Not yet recruiting
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South Carolina
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Anderson, South Carolina, United States, 29621
- Not yet recruiting
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Tennessee
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Knoxville, Tennessee, United States, 37938
- Not yet recruiting
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Texas
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Houston, Texas, United States, 77099
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Houston, Texas, United States, 77002
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Houston, Texas, United States, 77087
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San Antonio, Texas, United States, 78231
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Tomball, Texas, United States, 77375
- Not yet recruiting
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Victoria, Texas, United States, 77901
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Utah
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Layton, Utah, United States, 84041
- Not yet recruiting
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Salt Lake City, Utah, United States, 84109
- Recruiting
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South Jordan, Utah, United States, 84095
- Recruiting
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Virginia
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Richmond, Virginia, United States, 23219
- Not yet recruiting
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Washington
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Redmond, Washington, United States, 98052
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Laroprovstat
The patient will receive a daily dose of Laroprovstat
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daily oral dose of the Laroprovstat
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
|
|
Placebo Comparator: Placebo
The patient will receive a daily dose of Placebo
|
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
|
|
Experimental: Laroprovstat/Rosuvastatin dose combination 1
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
|
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 1
|
|
Experimental: Laroprovstat/Rosuvastatin dose combination 2
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
|
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
|
|
Active Comparator: Rosuvastatin dose 1
The patient will receive a daily dose of Rosuvastatin 1
|
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Rosuvastatin 1
|
|
Active Comparator: Rosuvastatin dose 2
The patient will receive a daily dose of Rosuvastatin 2
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daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Rosuvastatin 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative change in LDL-C at 8 weeks
Time Frame: 8 weeks
|
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks:
|
8 weeks
|
|
Relative change in LDL-C at 8 weeks
Time Frame: 8 weeks
|
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks:
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative change in LDL-C
Time Frame: 8 weeks
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks
|
8 weeks
|
|
Relative change in Apo B
Time Frame: 8 weeks
|
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks
|
8 weeks
|
|
Relative change in non-HDL-C
Time Frame: 8 weeks
|
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
|
8 weeks
|
|
Relative change in total cholesterol
Time Frame: 8 weeks
|
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2026
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Study Registration Dates
First Submitted
May 26, 2026
First Submitted That Met QC Criteria
May 26, 2026
First Posted (Actual)
June 1, 2026
Study Record Updates
Last Update Posted (Actual)
September 10, 2026
Last Update Submitted That Met QC Criteria
September 7, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7961C00002
- 2026-525642-30-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.