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NCT07889245
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
Conditions: sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 192
Sponsor: Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.
Location: Peking University Third Hospital Beijing Beijing Municipality
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial evaluating the efficacy and safety of FXR0906 in patients with severe hypertriglyceridemia or hypertriglyceridemia with atherosclerotic cardiovascular disease (diagnosed or at increased risk).
Eligibility Criteria
Inclusion Criteria:
1. Males or females aged between 18 and 75 years (inclusive) at screening;
2. Body mass index (BMI) ranging from 18 to 40 kg/m² (inclusive) at screening; body weight \>45 kg for female participants and \>50 kg for male participants.
3、Fall into at least 1 of the following groups (a or b):
1. sHTG i) Medical history of fasting TG level ≥500 mg/dL (≥5.65 mmol/L); ii) Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L), obtained from two separate consecutive visits during the screening period with an interval of at least 7 days and no more than 14 days; iii) Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening; or
2. HTG with ASCVD (diagnosed or at increased risk) i)Medical history of fasting TG ≥200 mg/dL (≥2.26 mmol/L) and \
Source: ClinicalTrials.gov (NCT07889245). StuddyBuddy aggregates publicly available trial information.