Type 2 Diabetes MellitusPhase 4NCT07255820
Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
A Phase 4 study testing Rosuvastatin + Ezetimibe, Bempedoic Acid + Ezetimibe and Rosuvastatin + Ezetimibe + Bempedoic Acid in people with Type 2 Diabetes Mellitus and Hypercholesterolemia / Elevated LDL Cholesterol, run by Bahria University at 1 site in Pakistan.
Trial summary
This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypercholesterolemia / Elevated LDL Cholesterol
- What is being tested?
- Rosuvastatin + Ezetimibe, Bempedoic Acid + Ezetimibe and Rosuvastatin + Ezetimibe + Bempedoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females
- Age 35-60 years
- HbA1c ≥ 7.0 (≥ 48 mmol/mol)
- On stable anti-diabetic therapy for at least 3 months
- LDL-C > 100 mg/dL on at least two occasions
- Diagnosed with hypercholesterolemia
Show all 10Show fewer
- Establish high cardiovascular risk (e.g, previous MI, stroke or atherosclerosis) or
- ≥2 cardiovascular risk factors (hypertension, smoking, obesity, family history)
- BMI >23 - <32(WHO Asian Criteria)
- No prior statin side effects
Who cannot join
- HbA1c >10 % (86 mmol/mol)
- BMI > 32
- Type 1 Diabetes, gestational diabetes
- Pregnancy or lactation
- Acute liver disease or ALT/AST levels > 3× the upper limit of normal
- Renal failure (GFR < 30 mL/min)
Show all 11Show fewer
- Uncontrolled hypothyroidism or nephrotic syndrome
- Recent cancer diagnosis (last 6 months)
- Current use of other lipid-lowering agents (e.g., fibrates or PCSK9 inhibitors)
- Known allergy to any component
- Statin intolerance with severe adverse effects (e.g., rhabdomyolysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. The study aims to determine whether adding bempedoic acid to standard dual therapy provides superior lipid control without compromising safety. The 126 participants, aged 35 - 60 years will be randomly assigned to one of three treatment groups for 12 weeks, and their lipid profiles, glycemic control, and adverse effects will be monitored.The total duration of study will be 6 months, with a 3 months individual treatment period.
Read the detailed description
This is a single-center, randomized, open-label clinical trial conducted over a 12-week period to evaluate the comparative efficacy and safety of dual versus triple lipid-lowering therapy in patients with type 2 diabetes mellitus (T2DM) and elevated LDL cholesterol (LDL-C).
The trial includes three treatment arms, Arm A will receive Rosuvastatin + Ezetimibe, Arm B will receive Bempedoic Acid + Ezetimibe and Arm C will receive Rosuvastatin + Ezetimibe + Bempedoic Acid.
Eligible participants are adults aged 35 - 60 years with a confirmed diagnosis of type 2 diabetes mellitus and elevated LDL cholesterol despite standard care. Exclude patients with severe hepatic or renal impairment, history of gout or hyperuricemia, muscle disorders or previous statin intolerance or Participation in another clinical trial within 30 days All participants will be randomly assigned to one of the three arms. Baseline assessments include lipid profile (TC, TG, HDL, LDL, VLDL), glycemic parameters (FBS, RBS, HbA1c), creatine kinase, uric acid, and documentation of medical history and concomitant medications. Follow-up assessments will occur at week 12 to evaluate changes in primary and secondary outcomes.
The primary outcome is change in LDL cholesterol from baseline to 12 weeks and secondary Outcomes include total cholesterol (TC), high-density lipoprotein (HDL), triglycerides (TG), very-low-density lipoprotein (VLDL), creatine kinase (CK), Uric acid, glycemic control like HbA1c, fasting blood sugar (FBS), random blood sugar (RBS), safety and tolerability including muscle spasm, myalgia, or gout attacks Safety Monitoring through all adverse events will be recorded during the study. If participants reporting muscle symptoms or hyperuricemia will be evaluated promptly. Laboratory tests will be repeated at study completion or earlier if clinically indicated.
This study is designed to assess whether the addition of bempedoic acid to standard dual therapy provides superior lipid-lowering efficacy without increasing adverse events in T2DM patients with elevated LDL-C. The findings will inform clinical practice on optimal lipid-lowering strategies for high-risk diabetic patients.
The study has received approval from BUHS-IRB (#180/25) and will be conducted in accordance with Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participants before study procedures.
- Being tested
- Rosuvastatin + Ezetimibe, Bempedoic Acid + Ezetimibe, Rosuvastatin + Ezetimibe + Bempedoic Acid
- Keywords
- Lipid-lowering therapy,, Rosuvastatin, Ezetimibe, Bempedoic Acid, Dual therapy vs Triple therapy, LDL-C, Dyslipidemia, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia, Hyperlipoproteinemia Type II, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin + EzetimibeDrug
Group A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days
Bempedoic Acid + EzetimibeDrug
Group B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days
Rosuvastatin + Ezetimibe + Bempedoic AcidDrug
Group C (Triple therapy): Tab Rosuvastatin 20 mg+ Tab Ezetimibe 10mg+ Tab Bempedoic Acid 180mg orally, once daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin + Ezetimibe | Active comparator | Rosuvastatin is a statin that lowers LDL cholesterol by inhibiting HMG-CoA reductase. Ezetimibe inhibits cholesterol absorption in the intestine. Receives: Drug: Rosuvastatin + Ezetimibe |
| Bempedoic Acid + Ezetimibe | Active comparator | Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol. Ezetimibe inhibits diatery cholesterol absorption in the intestine Receives: Drug: Bempedoic Acid + Ezetimibe |
| Rosuvastatin + Ezetimibe + Bempedoic Acid | Active comparator | This triple therapy combines statin therapy with cholesterol absorption inhibition and ATP citrate lyase inhibition to optimize LDL reduction. Receives: Drug: Rosuvastatin + Ezetimibe + Bempedoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL
The study will measure the percent change in LDL-C from baseline to 12 weeks and the proportion of participants achieving LDL-C <70 mg/dL as per international guidelines.
Measured: 12 weeks
Secondary outcomes (7)
Secondary outcome : Change in Total Cholesterol Level From Baseline to 12 Weeks (mg/dL)
The study will measure the change in total cholesterol (mg/dL) from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
Measured: 12 weeks
Secondary Outcome : Change in Triglyceride Level From Baseline to 12 Weeks (mg/dL)
The study will measure the change in Triglyceride Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
Measured: 12 weeks
Secondary Outcome : Change in HDL-C Level From Baseline to 12 Weeks (mg/dL)
The study will measure the change in HDL-C Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
Measured: 12 weeks
Secondary Outcome : Change in VLDL Level From Baseline to 12 Weeks (mg/dL)
The study will measure the change in VLDL Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.
Measured: 12 weeks
Secondary Outcome (Safety - Muscle Marker): Change in Creatine Kinase (CK) Level From Baseline to 12 Weeks (U/L)
The study will monitor creatine kinase levels from baseline to 12 weeks to assess muscle-related safety of the therapies
Measured: 12 weeks
Secondary Outcome (Safety - Metabolic Marker): Change in Uric Acid Level From Baseline to 12 Weeks (mg/dL)
The study will monitor uric acid levels from baseline to 12 weeks to assess the metabolic safety of the therapies.
Measured: 12 weeks
Secondary Outcome (Adverse Events): Number of Participants Experiencing Treatment-Related Adverse Effects
The study will record any treatment-related adverse effects (e.g., muscle spasm, gout, gastrointestinal symptoms) over 12 weeks to assess overall safety.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Jan 2026
- Primary completion30 Mar 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Fatima khatoon, Bahria University
- Investigators
- Fatima Khatoon, MBBS, Principal investigator, Bahria University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255820
- Sponsor's protocol ID
- BUHS-IRB # 180/25
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) from all study participants, including demographic information, lipid profiles (TC, TG, HDL, LDL, VLDL), glycemic parameters (HbA1c, FBS, RBS), creatine kinase, uric acid, and adverse events, will be shared. Data will be fully anonymized to protect participant privacy
Publications
Laufs U, Ballantyne CM, Banach M, Bays H, Catapano AL, Duell PB, Goldberg AC, Gotto AM, Leiter LA, Ray KK, Bloedon LT, MacDougall D, Zhang Y, Mancini GBJ. Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials. J Clin Lipidol. 2022 May-Jun;16(3):286-297. doi: 10.1016/j.jacl.2022.03.001. Epub 2022 Mar 13.
PubMed 35346603Rubino J, MacDougall DE, Sterling LR, Hanselman JC, Nicholls SJ. Combination of bempedoic acid, ezetimibe, and atorvastatin in patients with hypercholesterolemia: A randomized clinical trial. Atherosclerosis. 2021 Mar;320:122-128. doi: 10.1016/j.atherosclerosis.2020.12.023. Epub 2020 Dec 31.
PubMed 33514449Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29.
PubMed 31357887Goldberg AC, Leiter LA, Stroes ESG, Baum SJ, Hanselman JC, Bloedon LT, Lalwani ND, Patel PM, Zhao X, Duell PB. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial. JAMA. 2019 Nov 12;322(18):1780-1788. doi: 10.1001/jama.2019.16585.
PubMed 31714986Bays HE, Banach M, Catapano AL, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Bloedon LT, Sasiela WJ, Ye Z, Ballantyne CM. Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials. J Clin Lipidol. 2020 Sep-Oct;14(5):649-659.e6. doi: 10.1016/j.jacl.2020.08.009. Epub 2020 Sep 2.
PubMed 32980290Pirillo A, Catapano AL. New insights into the role of bempedoic acid and ezetimibe in the treatment of hypercholesterolemia. Curr Opin Endocrinol Diabetes Obes. 2022 Apr 1;29(2):161-166. doi: 10.1097/MED.0000000000000706.
PubMed 34980867Nissen SE, Lincoff AM, Brennan D, Ray KK, Mason D, Kastelein JJP, Thompson PD, Libby P, Cho L, Plutzky J, Bays HE, Moriarty PM, Menon V, Grobbee DE, Louie MJ, Chen CF, Li N, Bloedon L, Robinson P, Horner M, Sasiela WJ, McCluskey J, Davey D, Fajardo-Campos P, Petrovic P, Fedacko J, Zmuda W, Lukyanov Y, Nicholls SJ; CLEAR Outcomes Investigators. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023 Apr 13;388(15):1353-1364. doi: 10.1056/NEJMoa2215024. Epub 2023 Mar 4.
PubMed 36876740Marazzi G, Caminiti G, Perrone MA, Campolongo G, Cacciotti L, Giamundo DM, Iellamo F, Severino P, Volterrani M, Rosano G. Addition of Bempedoic Acid to Statin-Ezetimibe versus Statin Titration in Patients with High Cardiovascular Risk: A Single-Centre Prospective Study. J Cardiovasc Dev Dis. 2024 Sep 14;11(9):286. doi: 10.3390/jcdd11090286.
PubMed 39330344
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
- ClinicalTrials.gov ID
- NCT07255820
- Acronym / sponsor ID
- BUHS-IRB # 180/25
- Keywords
- Lipid-lowering therapy,, Rosuvastatin, Ezetimibe, Bempedoic Acid, Dual therapy vs Triple therapy, LDL-C, Dyslipidemia, Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 1 Dec 2025 (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 Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. The study aims to determine whether adding bempedoic acid to standard dual therapy provides superior lipid control without compromising safety. The 126 participants, aged 35 - 60 years will be randomly assigned to one of three treatment groups for 12 weeks, and their lipid profiles, glycemic control, and adverse effects will be monitored.The total duration of study will be 6 months, with a 3 months individual treatment period.
Detailed description
This is a single-center, randomized, open-label clinical trial conducted over a 12-week period to evaluate the comparative efficacy and safety of dual versus triple lipid-lowering therapy in patients with type 2 diabetes mellitus (T2DM) and elevated LDL cholesterol (LDL-C).
The trial includes three treatment arms, Arm A will receive Rosuvastatin + Ezetimibe, Arm B will receive Bempedoic Acid + Ezetimibe and Arm C will receive Rosuvastatin + Ezetimibe + Bempedoic Acid.
Eligible participants are adults aged 35 - 60 years with a confirmed diagnosis of type 2 diabetes mellitus and elevated LDL cholesterol despite standard care. Exclude patients with severe hepatic or renal impairment, history of gout or hyperuricemia, muscle disorders or previous statin intolerance or Participation in another clinical trial within 30 days All participants will be randomly assigned to one of the three arms. Baseline assessments include lipid profile (TC, TG, HDL, LDL, VLDL), glycemic parameters (FBS, RBS, HbA1c), creatine kinase, uric acid, and documentation of medical history and concomitant medications. Follow-up assessments will occur at week 12 to evaluate changes in primary and secondary outcomes.
The primary outcome is change in LDL cholesterol from baseline to 12 weeks and secondary Outcomes include total cholesterol (TC), high-density lipoprotein (HDL), triglycerides (TG), very-low-density lipoprotein (VLDL), creatine kinase (CK), Uric acid, glycemic control like HbA1c, fasting blood sugar (FBS), random blood sugar (RBS), safety and tolerability including muscle spasm, myalgia, or gout attacks Safety Monitoring through all adverse events will be recorded during the study. If participants reporting muscle symptoms or hyperuricemia will be evaluated promptly. Laboratory tests will be repeated at study completion or earlier if clinically indicated.
This study is designed to assess whether the addition of bempedoic acid to standard dual therapy provides superior lipid-lowering efficacy without increasing adverse events in T2DM patients with elevated LDL-C. The findings will inform clinical practice on optimal lipid-lowering strategies for high-risk diabetic patients.
The study has received approval from BUHS-IRB (#180/25) and will be conducted in accordance with Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participants before study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin + Ezetimibe | Active comparator | Drug: Rosuvastatin + EzetimibeRosuvastatin is a statin that lowers LDL cholesterol by inhibiting HMG-CoA reductase. Ezetimibe inhibits cholesterol absorption in the intestine. |
| Bempedoic Acid + Ezetimibe | Active comparator | Drug: Bempedoic Acid + EzetimibeBempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol. Ezetimibe inhibits diatery cholesterol absorption in the intestine |
| Rosuvastatin + Ezetimibe + Bempedoic Acid | Active comparator | Drug: Rosuvastatin + Ezetimibe + Bempedoic AcidThis triple therapy combines statin therapy with cholesterol absorption inhibition and ATP citrate lyase inhibition to optimize LDL reduction. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males and females
- Age 35-60 years
- HbA1c ≥ 7.0 (≥ 48 mmol/mol)
- On stable anti-diabetic therapy for at least 3 months
- LDL-C > 100 mg/dL on at least two occasions
Key exclusion criteria (11 listed)
- HbA1c >10 % (86 mmol/mol)
- BMI > 32
- Type 1 Diabetes, gestational diabetes
- Pregnancy or lactation
- Acute liver disease or ALT/AST levels > 3× the upper limit of normal
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 |
|---|---|---|
| Rosuvastatin + EzetimibeGroup A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days | Drug | Rosuvastatin + Ezetimibe |
| Bempedoic Acid + EzetimibeGroup B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days | Drug | Bempedoic Acid + Ezetimibe |
| Rosuvastatin + Ezetimibe + Bempedoic AcidGroup C (Triple therapy): Tab Rosuvastatin 20 mg+ Tab Ezetimibe 10mg+ Tab Bempedoic Acid 180mg orally, once daily for 90 days | Drug | Rosuvastatin + Ezetimibe + Bempedoic Acid |
Primary outcome
Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL
Time frame: 12 weeks
The study will measure the percent change in LDL-C from baseline to 12 weeks and the proportion of participants achieving LDL-C <70 mg/dL as per international guidelines.
7 secondary outcomes
Secondary outcome : Change in Total Cholesterol Level From Baseline to 12 Weeks (mg/dL)
Time frame: 12 weeks
Secondary Outcome : Change in Triglyceride Level From Baseline to 12 Weeks (mg/dL)
Time frame: 12 weeks
Secondary Outcome : Change in HDL-C Level From Baseline to 12 Weeks (mg/dL)
Time frame: 12 weeks
Secondary Outcome : Change in VLDL Level From Baseline to 12 Weeks (mg/dL)
Time frame: 12 weeks
Secondary Outcome (Safety - Muscle Marker): Change in Creatine Kinase (CK) Level From Baseline to 12 Weeks (U/L)
Time frame: 12 weeks
Secondary Outcome (Safety - Metabolic Marker): Change in Uric Acid Level From Baseline to 12 Weeks (mg/dL)
Time frame: 12 weeks
Secondary Outcome (Adverse Events): Number of Participants Experiencing Treatment-Related Adverse Effects
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 35346603Laufs U, Ballantyne CM, Banach M, Bays H, Catapano AL, Duell PB, Goldberg AC, Gotto AM, Leiter LA, Ray KK, Bloedon LT, MacDougall D, Zhang Y, Mancini GBJ. Efficacy and safety of bempedoic acid in patients not receiving statins in phase 3 clinical trials. J Clin Lipidol. 2022 May-Jun;16(3):286-297. doi: 10.1016/j.jacl.2022.03.001. Epub 2022 Mar 13.
- Background: PubMed 33514449Rubino J, MacDougall DE, Sterling LR, Hanselman JC, Nicholls SJ. Combination of bempedoic acid, ezetimibe, and atorvastatin in patients with hypercholesterolemia: A randomized clinical trial. Atherosclerosis. 2021 Mar;320:122-128. doi: 10.1016/j.atherosclerosis.2020.12.023. Epub 2020 Dec 31.
- Background: PubMed 31357887Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29.
- Background: PubMed 31714986Goldberg AC, Leiter LA, Stroes ESG, Baum SJ, Hanselman JC, Bloedon LT, Lalwani ND, Patel PM, Zhao X, Duell PB. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial. JAMA. 2019 Nov 12;322(18):1780-1788. doi: 10.1001/jama.2019.16585.
- Background: PubMed 32980290Bays HE, Banach M, Catapano AL, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Bloedon LT, Sasiela WJ, Ye Z, Ballantyne CM. Bempedoic acid safety analysis: Pooled data from four phase 3 clinical trials. J Clin Lipidol. 2020 Sep-Oct;14(5):649-659.e6. doi: 10.1016/j.jacl.2020.08.009. Epub 2020 Sep 2.
- Background: PubMed 34980867Pirillo A, Catapano AL. New insights into the role of bempedoic acid and ezetimibe in the treatment of hypercholesterolemia. Curr Opin Endocrinol Diabetes Obes. 2022 Apr 1;29(2):161-166. doi: 10.1097/MED.0000000000000706.
- Background: PubMed 36876740Nissen SE, Lincoff AM, Brennan D, Ray KK, Mason D, Kastelein JJP, Thompson PD, Libby P, Cho L, Plutzky J, Bays HE, Moriarty PM, Menon V, Grobbee DE, Louie MJ, Chen CF, Li N, Bloedon L, Robinson P, Horner M, Sasiela WJ, McCluskey J, Davey D, Fajardo-Campos P, Petrovic P, Fedacko J, Zmuda W, Lukyanov Y, Nicholls SJ; CLEAR Outcomes Investigators. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023 Apr 13;388(15):1353-1364. doi: 10.1056/NEJMoa2215024. Epub 2023 Mar 4.
- Background: PubMed 39330344Marazzi G, Caminiti G, Perrone MA, Campolongo G, Cacciotti L, Giamundo DM, Iellamo F, Severino P, Volterrani M, Rosano G. Addition of Bempedoic Acid to Statin-Ezetimibe versus Statin Titration in Patients with High Cardiovascular Risk: A Single-Centre Prospective Study. J Cardiovasc Dev Dis. 2024 Sep 14;11(9):286. doi: 10.3390/jcdd11090286.
- ACC/AHA cholesterol management guidelinesLink provided by the sponsor.
- ADA information on diabetes and cardiovascular risk.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) from all study participants, including demographic information, lipid profiles (TC, TG, HDL, LDL, VLDL), glycemic parameters (HbA1c, FBS, RBS), creatine kinase, uric acid, and adverse events, will be shared. Data will be fully anonymized to protect participant privacy
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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. This study is not recruiting at the moment.
Fatima Khatoon, MBBS principal investigator
Bahria University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin + Ezetimibe, Bempedoic Acid + Ezetimibe and Rosuvastatin + Ezetimibe + Bempedoic Acid in people with Type 2 Diabetes Mellitus and Hypercholesterolemia / Elevated LDL Cholesterol, run by Bahria University at 1 site in Pakistan.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 20 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 1 site in Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255820, which also lists 8 linked publications.
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 20 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.