Safety and Efficacy of IBI306 in HeFH Patients

NCT04179669 | Completed Phase 3

• 1 other identifier: CIBI306C301
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol (LDL-C) uptake. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.

Conditions

Heterozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage of LDL-C decreased from baseline injection.

  at 12 weeks

Secondary Outcomes (3)

• Percentage change of LDL-C from baseline

  to 24 weeks

• Changes in LDL-C levels relative to baselin

  at 12 and 24 weeks

• The proportion of patients with LDL-C that were 50% lower than baseline

  by 12 weeks and 24 weeks

Study Arms (2)

IBI306

EXPERIMENTAL

Participants received IBI306 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks.

Drug: IBI306

placebo

EXPERIMENTAL

Participants received Placebo 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks.

Drug: placebo

Interventions

IBI306 DRUG

Administered by subcutaneous injection

IBI306

placebo DRUG

Administered by subcutaneous injection

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide a signed and dated informed consent form
• Men or women 18 to 70 years of age at screening
• Weight ≥ 40 kg during screening
• Confirmed diagnosis of heterozygous familial hypercholesterolemia
• Maintain a low-fat diet and stabilize the current lipid-lowering therapy

You may not qualify if:

• Patients diagnosed as homozygous familial hypercholesterolemia
• Dialysis or plasmapheresis performed within 4 months prior to screening
• History of liver transplant
• Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening
• New York Heart Association (NYHA) grade III or IV heart failure, or recent detection of left ventricular ejection fraction ≤ 30%
• Have serious cardiovascular, cerebrovascular, liver and kidney related diseases

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

• Chai M, He Y, Zhao W, Han X, Zhao G, Ma X, Qiao P, Shi D, Liu Y, Han W, An P, Li H, Yan S, Ma Q, Deng H, Qian L, Zhou Y; CREDIT-2 investigators. Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2). BMC Med. 2023 Feb 28;21(1):77. doi: 10.1186/s12916-023-02797-8.

  PMID: 36855099 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: December 20, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

CN (1)