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A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

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Innovent Biologics

Status and phase

Completed
Phase 3
Phase 2

Conditions

Homozygous Familial Hypercholesterolemia

Treatments

Biological: IBI306

Study type

Interventional

Funder types

Industry

Identifiers

NCT04031742
CIBI306A201

Details and patient eligibility

About

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

Full description

This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Enrollment

18 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Part 1: IBI306
Experimental group
Description:
Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.
Treatment:
Biological: IBI306
Biological: IBI306
Part 2: IBI306
Experimental group
Description:
Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.
Treatment:
Biological: IBI306
Biological: IBI306

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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