A Study of IBI306 in Participants With Hypercholesterolemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-09

Study Completion Date

2022-01-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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IBI306

IBI306 administered subcutaneously (SC)

Group Type EXPERIMENTAL

IBI306

Intervention Type DRUG

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Placebo

administered subcutaneously (SC)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Interventions

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IBI306

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Intervention Type DRUG

Placebo

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No