Hyperlipidemia MedDRA version: 14.1 Level: LLT Classification code 10020667 Term: Hyperlipidemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: AMG 145
Pharmaceutical Form: Solution for injection
Current Sponsor code: AMG 145
Other descriptive name: AMG 145
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: eq
Sponsors
Amgen Inc
Eligibility
Inclusion criteria
Inclusion criteria: - Subject has provided informed consent. - Male or female = 18 to = 75 years of age at screening - Fasting LDL-C = 75 mg/dL as determined by central laboratory at the initial screening visit - Fasting LDL-C as determined by central laboratory at the end of the lipid stabilization period = 75 mg/dL (2.0 mmol/L) and meeting the following LDL-C values based on risk factor status (NCEP ATPIII risk categories Grundy et al, 2004): • 20%). Risk factors include cigarette smoking, hypertension (BP = 140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (=65 years) yes F.1.3.1 Number of subjects for this age range 360
Exclusion criteria
Exclusion criteria: - Diagnosed with CHD or CHD risk equivalent and not receiving statin therapy, with LDL-C at screening = 99 mg/dL - NYHA II, III or IV heart failure, or last known left ventricular ejection fraction 160 mmHg or diastolic BP (DBP) > 100 mmHg, confirmed with repeat measurement - Subject has taken in the last 6 weeks prior to LDL-C screening red yeast rice, > 200 mg/day niacin, or >1000 mg/day omega-3 fatty acids (eg, DHA and EPA) or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins -Treatment in the last 3 months prior to LDL-C screening with any of the following drugs: systemic cyclosporine, systemic steroids (eg IV, intramuscular [IM], or PO) (Note: hormone replacement therapy is permitted), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (eg, Accutane); (Note: vitamin A in a multivitamin preparation is permitted) Hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone TSH below the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening - Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) 2 times the ULN as determined by central laboratory analysis at screening or at end of lipid stabilization period, confirmed by a CK > 3 times the ULN at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart - Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator - Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization - Current therapeutic anticoagulation with vitamin K antagonist (eg, warfarin), heparin, low-molecular weight heparin, direct thrombin inhibitor, or Factor Xa inhibitor. (Note: anti-platelet agents [eg, aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole] are permitted). - Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis) - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) - Female subject who is not willing to use at least 1 highly effective method o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of 52 weeks of subcutaneous (SC) AMG 145 monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when added to background lipid-lowering therapy;Secondary Objective: • To evaluate the safety and tolerability of SC AMG 145, given for 52 weeks compared to placebo in subjects with hyperlipidemia on background lipid lowering therapy • To assess the effects of 52 weeks of SC AMG 145 compared to placebo on change from baseline in LDL-C, and percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio, Lipoprotein (a) [Lp(a)], triglycerides, total cholesterol, VLDL-C and HDL-C in subjects with hyperlipidemia on background lipid lowering therapy • To evaluate the consistency of the long term treatment effect of SC AMG 145 compared to placebo in subjects;Primary end point(s): Percent change from baseline in LDL-C at week 52;Timepoint(s) of evaluation of this end point: At week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints (Hypothesis Testing) Tier 1 • Change from baseline in LDL-C at week 52 • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52 • Percent change from baseline in LDL-C at week 12 • Percent change from baseline in TC at week 12 • Percent change from baseline in TC at week 52 • Percent change from baseline in non-HDL-C at week 52 • Percent change from baseline in ApoB at week 52 • Percent change from baseline in the total cholesterol/HDL-C ratio at week 52 • Percent change from baseline in ApoB/ApoA1 ratio at week 52 Tier 2 • Percent change from baseline in Lp(a) at week 52 • Percent change from baseline in triglycerides at week 52 • Percent change from baseline in HDL-C at week 52 • Percent change from baseline in VLDL-C at week 52 Secondary Endpoint (Estimation) • Percent change from week 12 in LDL-C at week 52;Timepoint(s) of evaluation of this end point: Secondary Endpoints (Hypothesis Testing) Tier 1 • Change from baseline in LDL-C at week 52 • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 52 • Percent change from baseline in LDL-C at week 12 • Percent change from baseline in non-HDL-C at week 52 • Percent change from baseline in ApoB at week 52 • Percent change from baseline in the total cholesterol/HDL-C ratio at week 52 • Percent change from baseline in ApoB/ApoA1 ratio at week 52 Tier 2 • Percent change from baseline in Lp(a) at week 52 • Percent change from baseline in triglycerides at week 52 • Percent change from baseline in HDL-C and VLDL-C at week 52 Secondary Endpoint (Estimation) • Percent change from week 12 in LDL-C at week 52 | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Hungary, South Africa, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed