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A PHASE 2, RANDOMIZED, PLACEBO CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS (R1500-HTG-1522)

Study category: Diabetes & Hormone Disorders

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Details
Age

Adult

Eligibility

Males and females 18 to 75 years of age at screening Previous record of fasting serum triglyceride (TG) measurement > 1000 mg/dL and all fasting TG values > 500 mg/dL History of hospitalization and diagnosis of acute pancreatitis in the past 10 years.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Outcomes Research

Location

University of Colorado Hospital

Principal Investigator
Marc-Andre Cornier,  MD

Marc-Andre Cornier, MD

Study ID

Protocol Number: 17-2118

ClinicalTrials.gov: NCT03452228

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