A Study of IBI306 in Participants With Hypercholesterolemia
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)
1 other identifier
interventional
306
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2021
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedStudy Start
First participant enrolled
February 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2022
CompletedOctober 31, 2024
October 1, 2024
9 months
January 12, 2021
October 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
Baseline to week12
Secondary Outcomes (3)
The percent of subjects with LDL-C reduction no less than 50% from baseline
Baseline to week24
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Baseline to week24
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Baseline to week24
Study Arms (2)
IBI306
EXPERIMENTALIBI306 administered subcutaneously (SC)
Placebo
PLACEBO COMPARATORadministered subcutaneously (SC)
Interventions
Eligibility Criteria
You may qualify if:
- Males and females ≥ 18 to ≤ 75 years of age
- Diagnosis of hypercholesterolemia
- LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
- Very high or high cardiovascular risk
- TG≤500 mg/dL(5.64 mmol/L)
You may not qualify if:
- Uncontrolled hypertension
- Uncontrolled hyperthyroidism or hypothyroidism
- Severe renal dysfunction
- Known sensitivity to any of the products to be administered during dosing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, China
Related Publications (1)
Qi L, Liu D, Qu Y, Chen B, Meng H, Zhu L, Li L, Wang S, Liu C, Zheng G, Lian Q, Yin G, Lv L, Lu D, Chen X, Xue F, An P, Li H, Deng H, Li L, Qian L, Huo Y. Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. JACC Asia. 2023 Jul 11;3(4):636-645. doi: 10.1016/j.jacasi.2023.04.011. eCollection 2023 Aug.
PMID: 37614541DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 14, 2021
Study Start
February 9, 2021
Primary Completion
November 9, 2021
Study Completion
January 28, 2022
Last Updated
October 31, 2024
Record last verified: 2024-10