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
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- STATUS
- Recruiting
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- participants needed
- 10
Summary
A phase 2, randomized, placebo-controlled study designed to evaluate the efficacy and safety of repeated doses of evinacumab in adult patients with severe hypertriglyceridemia. The study consists of screening period (up to 37 days), a baseline/single-blind placebo run in period, a 12-week double-blind treatment period, a single-blind 12 week treatment period and an off-treatment follow-up period. Subjects will have the following procedures: blood work, LPL activity test, daily symptom questionnaire and a symptom/dietary impact questionnaire (hypertriglyceridemia and Acute Pancreatitis Signs and Symptoms), physical examiniation, ECG, MRI, and FDG-PET
Description
FAQ
Details
| Condition | TBD |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | 03452228 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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