HypercholesterolaemiaPhase 3NCT07619131
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.
A Phase 3 study testing Laroprovstat, Rosuvastatin 1 and Rosuvastatin 2 in people with Hypercholesterolaemia, run by AstraZeneca at 152 sites in 11 countries.
Trial summary
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. 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 and Rosuvastatin 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 152 sitesin 11 countries
- Study dates
- 12 Aug 2026to 30 Jul 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 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
Who cannot join
- Asian origin.
- Statin intolerance
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- Inadequately treated hypothyroidism
Trial locations and contacts
152 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
152 sites in 11 countries
United States77 sites, 77 recruiting
- Not yet recruiting
Research Site
Anderson, South Carolina, 29621
- Not yet recruiting
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Annapolis, Maryland, 21401
- Not yet recruiting
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Arvada, Colorado, 80002
- Not yet recruiting
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Astoria, New York, 11106
- Not yet recruiting
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Atlanta, Georgia, 30303
- Not yet recruiting
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Beltsville, Maryland, 20705
- Not yet recruiting
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Bowie, Maryland, 20715
- Not yet recruiting
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Brooklyn, New York, 11201
- Not yet recruiting
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Brooklyn, New York, 11220
- Not yet recruiting
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Champaign, Illinois, 61822
- Not yet recruiting
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Chandler, Arizona, 85225
- Not yet recruiting
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Chicago, Illinois, 60607
- Not yet recruiting
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Chicago, Illinois, 60640
- Not yet recruiting
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Clearwater, Florida, 33765
- Recruiting
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Colorado Springs, Colorado, 80909
- Not yet recruiting
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Columbus, Ohio, 43213
- Recruiting
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Conyers, Georgia, 30094
- Not yet recruiting
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Dayton, Ohio, 45424
- Not yet recruiting
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Decatur, Georgia, 30030
- Not yet recruiting
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DeLand, Florida, 32720
- Not yet recruiting
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Derby, Kansas, 67037
- Not yet recruiting
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Dothan, Alabama, 36305
- Not yet recruiting
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Durham, North Carolina, 27705
- Not yet recruiting
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Evansville, Indiana, 47714
- Not yet recruiting
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Flint, Michigan, 48503
- Recruiting
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Hinesville, Georgia, 31313
- Not yet recruiting
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Hollywood, Florida, 33021
- Not yet recruiting
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Houston, Texas, 77002
- Not yet recruiting
Research Site
Houston, Texas, 77087
- Not yet recruiting
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Houston, Texas, 77099
- Not yet recruiting
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Huntington Beach, California, 92647
- Not yet recruiting
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Island Lake, Illinois, 60042
- Not yet recruiting
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Jacksonville, Florida, 32209
- Not yet recruiting
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Kansas City, Missouri, 64108
- Not yet recruiting
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Knoxville, Tennessee, 37938
- Recruiting
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Lakeland, Florida, 33813
- Not yet recruiting
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Layton, Utah, 84041
- Recruiting
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Lexington, Kentucky, 40503
- Not yet recruiting
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Loma Linda, California, 92354
- Not yet recruiting
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Lomita, California, 90717
- Not yet recruiting
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Long Beach, California, 90815
- Not yet recruiting
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Louisville, Kentucky, 40205
- Not yet recruiting
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Lutherville-Timonium, Maryland, 21093
- Not yet recruiting
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Melrose Park, Illinois, 60160
- Not yet recruiting
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Miami Lakes, Florida, 33016
- Recruiting
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Millville, New Jersey, 08332
- Not yet recruiting
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Morehead City, North Carolina, 28557
- Not yet recruiting
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Newport, Pennsylvania, 17074
- Not yet recruiting
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Ocoee, Florida, 34761
- Not yet recruiting
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Oxon Hill, Maryland, 20745
- Not yet recruiting
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Palos Hills, Illinois, 60465
- Not yet recruiting
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Peachtree Corners, Georgia, 30092
- Not yet recruiting
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Phoenix, Arizona, 85053
- Not yet recruiting
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Plantation, Florida, 33324
- Not yet recruiting
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Port Orange, Florida, 32127
- Not yet recruiting
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Portland, Oregon, 97223
- Not yet recruiting
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Redmond, Washington, 98052
- Not yet recruiting
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Richmond, Virginia, 23219
- Recruiting
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Salt Lake City, Utah, 84109
- Not yet recruiting
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San Antonio, Texas, 78231
- Not yet recruiting
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San Dimas, California, 91773
- Not yet recruiting
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Smithfield, Pennsylvania, 15478
- Recruiting
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South Jordan, Utah, 84095
- Not yet recruiting
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St Louis, Missouri, 63110
- Not yet recruiting
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St Louis, Missouri, 63136
- Not yet recruiting
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Statesville, North Carolina, 28625
- Not yet recruiting
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Tampa, Florida, 33606
- Not yet recruiting
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The Bronx, New York, 10455
- Not yet recruiting
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Tomball, Texas, 77375
- Not yet recruiting
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Troy, Michigan, 48098
- Not yet recruiting
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Tulsa, Oklahoma, 74137
- Not yet recruiting
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Victoria, Texas, 77901
- Not yet recruiting
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Waterbury, Connecticut, 06708
- Not yet recruiting
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Waterloo, Iowa, 50701
- Not yet recruiting
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Wilmington, North Carolina, 28401
- Not yet recruiting
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Winston-Salem, North Carolina, 27157
- Not yet recruiting
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Zachary, Louisiana, 70791
Germany12 sites, 12 recruiting
- Not yet recruiting
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Ahrensburg, 22926
- Not yet recruiting
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Berlin, 10787
- Not yet recruiting
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Bochum, 44789
- Not yet recruiting
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Gladbeck, 45968
- Not yet recruiting
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Hamburg, 20095
- Not yet recruiting
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Hanover, 30449
- Not yet recruiting
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Karlsruhe, 76137
- Not yet recruiting
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Leipzig, 04177
- Not yet recruiting
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Löhne, 32584
- Not yet recruiting
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Magdeburg, 39110
- Not yet recruiting
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Obertshausen, 63179
- Not yet recruiting
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Wiesbaden, 65189
Bulgaria9 sites, 9 recruiting
- Not yet recruiting
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Burgas, 8000
- Not yet recruiting
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Plovdiv, 4002
- Not yet recruiting
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Razgrad, 7200
- Not yet recruiting
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Sevlievo, 5400
- Not yet recruiting
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Sofia, 1202
- Not yet recruiting
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Sofia, 1431
- Not yet recruiting
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Sofia, 1527
- Not yet recruiting
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Varna, 9010
- Not yet recruiting
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Veliko Tarnovo, 5006
Poland9 sites, 7 recruiting
- Not yet recruiting
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Częstochowa, 42-217
- Suspended
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Gdynia, 81-384
- Not yet recruiting
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Katowice, 40-772
- Suspended
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Lodz, 91-363
- Not yet recruiting
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Lodz, 93-338
- Not yet recruiting
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Lublin, 20-011
- Not yet recruiting
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Lublin, 20-718
- Not yet recruiting
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Warsaw, 00-719
- Not yet recruiting
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Warsaw, 02-758
Denmark8 sites, 8 recruiting
- Not yet recruiting
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Aarhus, 8200
- Not yet recruiting
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Copenhagen, 2400
- Not yet recruiting
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Gandrup, 9362
- Not yet recruiting
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Herlev, 2730
- Not yet recruiting
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Herning, 7400
- Not yet recruiting
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Svendborg, 5700
- Not yet recruiting
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Vejle, 7100
- Not yet recruiting
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Viborg, 8800
Ukraine8 sites, 8 recruiting
- Not yet recruiting
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Ivano-Frankivsk, 76018
- Not yet recruiting
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Kyiv, 02002
- Not yet recruiting
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Kyiv, 03037
- Not yet recruiting
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Kyiv, 03049
- Not yet recruiting
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Kyiv, 04114
- Not yet recruiting
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Kyiv, 04210
- Not yet recruiting
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Lviv, 79016
- Not yet recruiting
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Uzhhorod, 88014
Spain7 sites, 7 recruiting
- Not yet recruiting
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Barcelona, 08025
- Not yet recruiting
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Barcelona, 08540
- Not yet recruiting
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Barcelona, 08902
- Not yet recruiting
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Figueres, 17600
- Not yet recruiting
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La Roca del Vallès, 08430
- Not yet recruiting
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Mataró, 08303
- Not yet recruiting
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Viladecans, 08840
Canada6 sites, 6 recruiting
- Not yet recruiting
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Chicoutimi, Quebec, G7H 7K9
- Recruiting
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Hamilton, Ontario, L8L 5G4
- Recruiting
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Scarborough Village, Ontario, M1R 0B1
- Recruiting
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Sherbrooke, Quebec, J1J 2G2
- Recruiting
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Stouffville, Ontario, L4A1H2
- Not yet recruiting
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Victoriaville, Quebec, G6P 3Z8
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
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Coventry, CV3 4FJ
- Not yet recruiting
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Knutsford, WA16 9DX
- Not yet recruiting
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London, W6 7HY
- Not yet recruiting
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Orpington, BR5 3QG
- Not yet recruiting
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Poole, BH14 8EE
- Not yet recruiting
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Shipley, BD18 3SA
Hungary5 sites, 5 recruiting
- Not yet recruiting
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Budapest, 1027
- Not yet recruiting
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Budapest, 1036
- Not yet recruiting
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Budapest, 1138
- Not yet recruiting
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Kaposvár, 7400
- Not yet recruiting
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Zalaegerszeg, 8900
Israel5 sites, 5 recruiting
- Not yet recruiting
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Haifa, 3109601
- Not yet recruiting
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Jerusalem, 9103102
- Not yet recruiting
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Jerusalem, 91120
- Not yet recruiting
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Kfar Saba, 4428164
- Not yet recruiting
Research Site
Petah Tikva, 49100
About this study
Official title: 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.
- Conditions
- Hypercholesterolaemia
- Being tested
- Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, Laroprovstat/Rosuvastatin 1, Placebo to match rosuvastatin
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaroprovstatDrug
daily oral dose of the Laroprovstat
Rosuvastatin 1Drug
daily oral dose of the Rosuvastatin 1
Rosuvastatin 2Drug
daily oral dose of the Rosuvastatin 2
Laroprovstat/Rosuvastatin 1Drug
daily oral dose of the Laroprovstat/Rosuvastatin 1
Placebo to match rosuvastatinDrug
daily oral dose of the Placebo to match Rosuvastatin
Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1Drug
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
Laroprovstat/Rosuvastatin 2Drug
daily oral dose of the Laroprovstat/Rosuvastatin 2
Placebo to match Laroprovstat/Rosuvastatin 2Drug
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
| Study group | Role | What they receive |
|---|---|---|
| Laroprovstat | Active comparator | The patient will receive a daily dose of Laroprovstat Receives: Drug: Laroprovstat; Drug: Placebo to match rosuvastatin; Drug: Placebo to match Laroprovstat/Rosuvastatin 2 |
| Placebo | Placebo comparator | The patient will receive a daily dose of Placebo Receives: Drug: Placebo to match rosuvastatin; Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1; Drug: Placebo to match Laroprovstat/Rosuvastatin 2 |
| Laroprovstat/Rosuvastatin dose combination 1 | Experimental | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1 Receives: Drug: Laroprovstat/Rosuvastatin 1; Drug: Placebo to match rosuvastatin; Drug: Placebo to match Laroprovstat/Rosuvastatin 2 |
| Laroprovstat/Rosuvastatin dose combination 2 | Experimental | The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2 Receives: Drug: Placebo to match rosuvastatin; Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1; Drug: Laroprovstat/Rosuvastatin 2 |
| Rosuvastatin dose 1 | Active comparator | The patient will receive a daily dose of Rosuvastatin 1 Receives: Drug: Rosuvastatin 1; Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1; Drug: Placebo to match Laroprovstat/Rosuvastatin 2 |
| Rosuvastatin dose 2 | Active comparator | The patient will receive a daily dose of Rosuvastatin 2 Receives: Drug: Rosuvastatin 2; Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1; Drug: Placebo to match Laroprovstat/Rosuvastatin 2 |
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 FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks:
- Placebo
- Rosuvastatin 2
- Laroprovstat
Measured: 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
Measured: 8 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
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 start12 Aug 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619131
- Sponsor's protocol ID
- D7961C00002
- Other IDs
- 2026-525642-30-00
- Status last verified
- Sep 2026
- First submitted
- 26 May 2026
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07619131
- Acronym / sponsor ID
- D7961C00002
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Laroprovstat | Active comparator | Drug: Laroprovstat, Drug: Placebo to match rosuvastatin, Drug: Placebo to match Laroprovstat/Rosuvastatin 2The patient will receive a daily dose of Laroprovstat |
| Placebo | Placebo comparator | Drug: Placebo to match rosuvastatin, Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1, Drug: Placebo to match Laroprovstat/Rosuvastatin 2The patient will receive a daily dose of Placebo |
| Laroprovstat/Rosuvastatin dose combination 1 | Experimental | Drug: Laroprovstat/Rosuvastatin 1, Drug: Placebo to match rosuvastatin, Drug: Placebo to match Laroprovstat/Rosuvastatin 2The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1 |
| Laroprovstat/Rosuvastatin dose combination 2 | Experimental | Drug: Placebo to match rosuvastatin, Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1, Drug: Laroprovstat/Rosuvastatin 2The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2 |
| Rosuvastatin dose 1 | Active comparator | Drug: Rosuvastatin 1, Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1, Drug: Placebo to match Laroprovstat/Rosuvastatin 2The patient will receive a daily dose of Rosuvastatin 1 |
| Rosuvastatin dose 2 | Active comparator | Drug: Rosuvastatin 2, Drug: Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1, Drug: Placebo to match Laroprovstat/Rosuvastatin 2The patient will receive a daily dose of Rosuvastatin 2 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Asian origin.
- Statin intolerance
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- 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 |
|---|---|---|
| Laroprovstatdaily oral dose of the Laroprovstat | Drug | Laroprovstat |
| Rosuvastatin 1daily oral dose of the Rosuvastatin 1 | Drug | Rosuvastatin dose 1 |
| Rosuvastatin 2daily oral dose of the Rosuvastatin 2 | Drug | Rosuvastatin dose 2 |
| Laroprovstat/Rosuvastatin 1daily oral dose of the Laroprovstat/Rosuvastatin 1 | Drug | Laroprovstat/Rosuvastatin dose combination 1 |
| Placebo to match rosuvastatindaily oral dose of the Placebo to match Rosuvastatin | Drug | Laroprovstat, Laroprovstat/Rosuvastatin dose combination 1, Laroprovstat/Rosuvastatin dose combination 2, Placebo |
| Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1 | Drug | Laroprovstat/Rosuvastatin dose combination 2, Placebo, Rosuvastatin dose 1, Rosuvastatin dose 2 |
| Laroprovstat/Rosuvastatin 2daily oral dose of the Laroprovstat/Rosuvastatin 2 | Drug | Laroprovstat/Rosuvastatin dose combination 2 |
| Placebo to match Laroprovstat/Rosuvastatin 2daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2 | Drug | Laroprovstat, Laroprovstat/Rosuvastatin dose combination 1, Placebo, Rosuvastatin dose 1, Rosuvastatin dose 2 |
Primary outcome
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: * Placebo * Rosuvastatin 2 * Laroprovstat
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: * Placebo * Rosuvastatin 1 * Laroprovstat
4 secondary outcomes
Relative change in LDL-C
Time frame: 8 weeks
Relative change in Apo B
Time frame: 8 weeks
Relative change in non-HDL-C
Time frame: 8 weeks
Relative change in total cholesterol
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 10 Sep 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.
152 sites in 11 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 and Rosuvastatin 2 in people with Hypercholesterolaemia, run by AstraZeneca at 152 sites in 11 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 3 inclusion and 5 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 152 sites in United States, Germany, Bulgaria, Poland, Denmark and 6 more countries. 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. Some participants in this study may receive a placebo. 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 (+18772409479, 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). The study lists 2 primary outcomes in all. 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 10 Sep 2026.