Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.

CIBI306A201

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

2019-09-29

2021-12-30

2021-12-30

Completed

Early phase I

18

Inclusion Criteria: 1. Males and females ≥ 18 to ≤ 80 years of age 2. Diagnosis of homozygous familial hypercholesterolemia 3. LDL cholesterol ≥ 130 mg/dL (3.4mmol/L) 4. Triglyceride ≤ 400 mg/dL (4.5 mmol/L) 5. Bodyweight of ≥ 40 kg at screening Exclusion Criteria: 1. History of liver transplant 2. Uncontrolled hypertension 3. Moderate to severe renal dysfunction 4. Active liver disease or hepatic dysfunction 5. Known sensitivity to any of the products to be administered during dosing

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 \\[ Time Frame: Baseline and Week 12 \\]', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2023-08-09