Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obicetrapib/Ezetimibe | Experimental | obicetrapib 10 mg + ezetimibe 10 mg FDC daily |
|
| Obicetrapib | Experimental | obicetrapib 10 mg daily |
|
| Placebo | Placebo Comparator | Placebo on top of guideline-recommended lipid-lowering therapy |
|
| Open-Label Extension | Experimental | Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| obicetrapib 10 mg + ezetimibe 10 mg FDC daily | Drug | FDC |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group | Day 84 | |
| Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Baseline over time in LDL-C | The percent change from Baseline at every visit for LDL-C | 40 weeks |
| Proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gagandeep Dhillon | Contact | 519-209-2341 | Gagandeep.dhillon@fortrea.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute of Arizona | Recruiting | Sun City West | Arizona | 85375 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This protocol includes a 12-week, 3-arm, placebo-controlled, double-blind treatment section, followed by a 40-week open-label extension period. All patients receive the FDC of obicetrapib 10mg and ezetimibe 10 mg, regardless of the intervention received in the double-blind treatment section of this trial.
Not provided
Not provided
Not provided
| Obicetrapib 10 mg | Drug | monotherapy |
|
| Placebo | Other | placebo on top of guideline-recommended lipid modifying therapy |
|
| 84 days |
| Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group | 84 days |
| Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group | 84 days |
| Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group; | 84 days |
| Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group | Day 84 |
| Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group | Day 84 |
| Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group | Day 84 |
| Percent change from Baseline to Day 84 in lipoprotein (a) (Lp[a]) for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group | Day 84 |
| Percent change from Baseline to Day 84 in Lp(a) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group | Day 84 |
The percent change from Baseline at every visit in the proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L)
| 40 weeks |
| Percent change from Baseline over time in non-HDL-C | The percent change from Baseline at every visit for non-HDL-C | 40 weeks |
| Percent change from Baseline over time in ApoB | The percent change from Baseline at every visit in ApoB | 40 weeks |
| Percent change from Baseline over time in total cholesterol | The percent change from Baseline at every visit for total cholesterol | 40 weeks |
| Percent change from Baseline over time in triglycerides | The percent change from baseline at every visit for triglycerides | 40 weeks |
| Percent change from Baseline over time in HDL-C | the percent change from Baseline at every visit for HDL-C | 40 weeks |
| Percent change from Baseline over time in Lp(a) | the percent change from Baseline at every visit for Lp(a) | 40 weeks |
| Scripps Health - Whittier Diabetes Institute |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| UF Health Jackson | Recruiting | Jacksonville | Florida | 32209 | United States |
| East Coast Institute of Research LLC | Recruiting | Jacksonville | Florida | 32216 | United States |
| East Coast Institute of Research LLC | Recruiting | Lake City | Florida | 32055 | United States |
| Floridian Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Recruiting | Louisville | Kentucky | 40213 | United States |
| MD Medical Research | Recruiting | Oxon Hill | Maryland | 20745 | United States |
| Jefferson City Medical Group | Recruiting | Jefferson City | Missouri | 65109 | United States |
| Montana Medical Research | Recruiting | Missoula | Montana | 59808 | United States |
| Inspira Health - Internal Medicine Associates | Recruiting | Bridgeton | New Jersey | 08302 | United States |
| Central New York Clinical Research | Recruiting | Manlius | New York | 13104 | United States |
| Velocity Clinical Research | Recruiting | Durham | North Carolina | 27710 | United States |
| Floridian Clinical Research | Recruiting | Greensboro | North Carolina | 27408 | United States |
| Centricity Research dba Lucas Research | Recruiting | Morehead City | North Carolina | 28557 | United States |
| Summit Research Group | Recruiting | Munroe Falls | Ohio | 44262 | United States |
| Juno Research LLC - Medical Center | Recruiting | Houston | Texas | 77054 | United States |
| Clinical Trials of Texas dba Flourish Research | Recruiting | San Antonio | Texas | 78229 | United States |
| Burke Internal Medicine | Recruiting | Burke | Virginia | 22015-2234 | United States |
| Burke International Medicine DBA Manassas Clinical Research Center | Recruiting | Manassas | Virginia | 20110 | United States |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided