A Study of IBI306 in Participants With Hypercholesterolemia

Innovent Biologics

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: IBI306; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04709536

CIBI306B201

Details and patient eligibility

About

This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.

Enrollment: 306 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Males and females ≥ 18 to ≤ 75 years of age
2. Diagnosis of hypercholesterolemia
3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
4. Very high or high cardiovascular risk
5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

1. Uncontrolled hypertension
2. Uncontrolled hyperthyroidism or hypothyroidism
3. Severe renal dysfunction
4. Known sensitivity to any of the products to be administered during dosing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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306 participants in 2 patient groups, including a placebo group

IBI306

Experimental group

Description:

IBI306 administered subcutaneously (SC)

Treatment:

Drug: IBI306

Placebo

Placebo Comparator group

Description:

administered subcutaneously (SC)

Treatment:

Drug: Placebo