Hypercholesterolemia
Conditions
Keywords
Hyperlipidemia
Brief summary
A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.
Detailed description
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.
Interventions
DRUGMB07811
Oral
DRUGPlacebo
Oral
Sponsors
Ligand Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening; * Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits; * Fasting mean serum LDL-C \<220 mg/dL from Q2 and Q3;
Exclusion criteria
* History of clinically significant cardiovascular disease * Uncontrolled hypertension * Significant sinus bradycardia defined as \<40 beats per minute (bpm); * Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome; * Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency \> 1 per minute, any alert criteria or any other condition that requires further evaluation; * History of clinical significant arrhythmia; * Resting 12-lead ECG showing QTc \>450 msec or \<360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality; * Any other cardiovascular event requiring hospitalization; * History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed. * Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy * History of human immunodeficiency virus (HIV); * Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated; * History of myopathy, including any history of statin-induced myopathy; * History of intolerance to statins (e.g., myalgias, elevated liver tests); * History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis; * Renal dysfunction; * Alcohol and/or drug abuse within 12 months prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effects of MB07811 compared to placebo on LDL-C | 12-weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effects of MB07811 on other lipid markers compared to placebo | 12 weeks |
| Assess the safety and tolerability of MB07811 | after 12 weeks of treatment and during off-drug phase |
Countries
United States
Outcome results
None listed