Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single to Multi-Dose Study of Safety, Tolerability, and Bioeffect of Subcutaneously Administered REGN727 in Patients With and Without Concomitant Atorvastatin
Brief Summary: This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Options:
A: Arm Label: Placebo Q2W; Type: PLACEBO_COMPARATOR; Interventions: Drug: Alirocumab, Drug: Placebo (for Alirocumab), Drug: Non-statin LMT, Other: Diet Alone | Arm Label: Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator); Type: OTHER; Interventions: Drug: Alirocumab, Drug: Non-statin LMT, Other: Diet Alone | Arm Label: Alirocumab 150 mg Q4W/Up to 150 mg Q2W; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Placebo (for Alirocumab), Drug: Non-statin LMT, Other: Diet Alone | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator), Placebo Q2W | Intervention Type: DRUG; Name: Placebo (for Alirocumab); Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Placebo Q2W | Intervention Type: DRUG; Name: Non-statin LMT; Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator), Placebo Q2W | Intervention Type: OTHER; Name: Diet Alone; Assigned to Arm(s): Alirocumab 150 mg Q4W/Up to 150 mg Q2W, Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator), Placebo Q2W
B: Arm Label: Placebo Q2W; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo (for alirocumab), Drug: Lipid Modifying Therapy (LMT) | Arm Label: Alirocumab 150 mg Q2W; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Lipid Modifying Therapy (LMT) | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 150 mg Q2W | Intervention Type: DRUG; Name: Placebo (for alirocumab); Assigned to Arm(s): Placebo Q2W | Intervention Type: DRUG; Name: Lipid Modifying Therapy (LMT); Assigned to Arm(s): Alirocumab 150 mg Q2W, Placebo Q2W
C: Arm Label: Group 1 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 2 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 3 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 4 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 5 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 6 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 7 without atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Arm Label: Group 8 with atorvastatin; Type: EXPERIMENTAL; Interventions: Drug: REGN727(SAR236553) | Intervention Type: DRUG; Name: REGN727(SAR236553); Assigned to Arm(s): Group 1 with atorvastatin, Group 2 with atorvastatin, Group 3 with atorvastatin, Group 4 with atorvastatin, Group 5 with atorvastatin, Group 6 with atorvastatin, Group 7 without atorvastatin, Group 8 with atorvastatin
D: Arm Label: Evolocumab; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab, Drug: Atorvastatin, Drug: Ezetimibe, Other: Diet Only | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Drug: Atorvastatin, Drug: Ezetimibe, Other: Diet Only | Intervention Type: BIOLOGICAL; Name: Evolocumab; Assigned to Arm(s): Evolocumab | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Evolocumab, Placebo | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Evolocumab, Placebo | Intervention Type: OTHER; Name: Diet Only; Assigned to Arm(s): Evolocumab, Placebo

Answer: C