Back to resultsEfficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemcabene
Atorvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL-C, Lipid Regulator
Eligibility Criteria
Inclusion Criteria:
- Males and Females
- 18-70 years old
- Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical washout visit OR
- Received no lipid-altering drugs since the initial clinic washout visit and had a mean LDL-C as follows at 2 qualifying visits:
- ≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR
- ≥ 160 mg/dL if NCEP ATP III CHD risk < 10%
- Had variability of 2 qualifying LDL-C <20% (i.e. lowest value/highest value >0.8). An additional qualifying visit may have been completed by patients who were washing off lipid medication in order to reassess LDL-C variability; and
- Had a mean LDL-C < 250 mg/dL at 2 qualifying visits
Exclusion Criteria:
- Women of childbearing potential, pregnant or lactating;
- Body Mass Index (BMI) >38kg/m²;
- TG >400 mg/dL at Visit B2 or B3
- Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);
- Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization
- Uncontrolled hypertension*
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any diabetic patient who takes insulin and/or thiazolidinediones
- Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0 mg/dL;
- Hepatic dysfunction
- Uncontrolled hypothyroidism
- Abnormal urinalysis
- Currently taking any of the following medications:
- Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine, itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;
- Thiazolidinediones (Avandia, Actos);
- Immunosuppressive agents;
- St. John's wort
- Taking any of the following lipid-altering medications within 5 weeks prior to randomization:
- Lipid-regulating drugs: Niacin (crystalline >500mg/day, slow release or time release), psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives, bile cholesterol absorption inhibitors including ezetimibe;
- Any supplement containing plan sterols/stanols (i.e. Benecol, beta-sitosterol, Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);
- Neomycin (oral);
- Adrenocortical steroids*
- Sibutramine (Meridia);
- Insulin;
- Orlistat (Xenical);
- Isotretinoin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Gemcabene 300 mg
Gemcabene 600 mg
Gemcabene 900 mg
Placebo
Atorvastatin 10 mg
Atorvastatin 40 mg
Atorvastatin 80 mg
Gemcabene 300 mg & Atorvastatin 10 mg
Gemcabene 300 mg & Atorvastatin 40 mg
Gemcabene 300 mg & Atorvastatin 80 mg
Gemcabene 600 mg & Atorvastatin 10 mg
Gemcabene 600 mg & Atorvastatin 40 mg
Gemcabene 600 mg & Atorvastatin 80 mg
Gemcabene 900 mg & Atorvastatin 10 mg
Gemcabene 900 mg & Atorvastatin 40 mg
Gemcabene 900 mg & Atorvastatin 80 mg
Arm Description
Gemcabene 300 mg QD
Gemcabene 600 mg QD
Gemcabene 900 mg QD
Outcomes
Primary Outcome Measures
LDL-C percent change from baseline
Secondary Outcome Measures
HDL-C percent change from baseline
TG percent change from baseline
Apolipoprotein-B percent change from baseline
Adverse Events
Clinical Laboratory
Clinical Laboratory Abnormalities
Full Information
NCT ID
NCT02591836
First Posted
October 22, 2015
Last Updated
April 8, 2020
Sponsor
NeuroBo Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02591836
Brief Title
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
Official Title
An 8-Week, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of Gemcabene Administered as Monotherapy or in Combination With Atorvastatin in the Treatment of Hypercholesterolemic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroBo Pharmaceuticals Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this placebo-controlled study is to evaluate the low-density lipoprotein cholesterol (LDL-C) efficacy and dose-response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients.
Secondary purposes include evaluating the effects of high-sensitivity C-reactive protein (hsCRP), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and apolipoprotein B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin combination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
LDL-C, Lipid Regulator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcabene 300 mg
Arm Type
Experimental
Arm Description
Gemcabene 300 mg QD
Arm Title
Gemcabene 600 mg
Arm Type
Experimental
Arm Description
Gemcabene 600 mg QD
Arm Title
Gemcabene 900 mg
Arm Type
Experimental
Arm Description
Gemcabene 900 mg QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Atorvastatin 10 mg
Arm Type
Active Comparator
Arm Title
Atorvastatin 40 mg
Arm Type
Active Comparator
Arm Title
Atorvastatin 80 mg
Arm Type
Active Comparator
Arm Title
Gemcabene 300 mg & Atorvastatin 10 mg
Arm Type
Experimental
Arm Title
Gemcabene 300 mg & Atorvastatin 40 mg
Arm Type
Experimental
Arm Title
Gemcabene 300 mg & Atorvastatin 80 mg
Arm Type
Experimental
Arm Title
Gemcabene 600 mg & Atorvastatin 10 mg
Arm Type
Experimental
Arm Title
Gemcabene 600 mg & Atorvastatin 40 mg
Arm Type
Experimental
Arm Title
Gemcabene 600 mg & Atorvastatin 80 mg
Arm Type
Experimental
Arm Title
Gemcabene 900 mg & Atorvastatin 10 mg
Arm Type
Experimental
Arm Title
Gemcabene 900 mg & Atorvastatin 40 mg
Arm Type
Experimental
Arm Title
Gemcabene 900 mg & Atorvastatin 80 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gemcabene
Intervention Description
Gemcabene
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
LDL-C percent change from baseline
Time Frame
56 days
Secondary Outcome Measure Information:
Title
HDL-C percent change from baseline
Time Frame
56 days
Title
TG percent change from baseline
Time Frame
56 days
Title
Apolipoprotein-B percent change from baseline
Time Frame
56 days
Title
Adverse Events
Time Frame
56 days
Title
Clinical Laboratory
Description
Clinical Laboratory Abnormalities
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and Females
18-70 years old
Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical washout visit OR
Received no lipid-altering drugs since the initial clinic washout visit and had a mean LDL-C as follows at 2 qualifying visits:
≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR
≥ 160 mg/dL if NCEP ATP III CHD risk < 10%
Had variability of 2 qualifying LDL-C <20% (i.e. lowest value/highest value >0.8). An additional qualifying visit may have been completed by patients who were washing off lipid medication in order to reassess LDL-C variability; and
Had a mean LDL-C < 250 mg/dL at 2 qualifying visits
Exclusion Criteria:
Women of childbearing potential, pregnant or lactating;
Body Mass Index (BMI) >38kg/m²;
TG >400 mg/dL at Visit B2 or B3
Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);
Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization
Uncontrolled hypertension*
Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any diabetic patient who takes insulin and/or thiazolidinediones
Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0 mg/dL;
Hepatic dysfunction
Uncontrolled hypothyroidism
Abnormal urinalysis
Currently taking any of the following medications:
Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine, itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;
Thiazolidinediones (Avandia, Actos);
Immunosuppressive agents;
St. John's wort
Taking any of the following lipid-altering medications within 5 weeks prior to randomization:
Lipid-regulating drugs: Niacin (crystalline >500mg/day, slow release or time release), psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives, bile cholesterol absorption inhibitors including ezetimibe;
Any supplement containing plan sterols/stanols (i.e. Benecol, beta-sitosterol, Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);
Neomycin (oral);
Adrenocortical steroids*
Sibutramine (Meridia);
Insulin;
Orlistat (Xenical);
Isotretinoin
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
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