IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

NCT07473960 | Recruiting Phase 3

• 1 other identifier: CIBI306B302
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed hyperlipidemia. Approximately 198 participants were planned to be enrolled in the study. The entire study period includes a screening period of no more than 2 weeks, a run-in period of 4 weeks, a double-blind treatment period of 12 weeks, and a safety follow-up period after the last treatment. Participants were required to maintain a stable and healthy lifestyle throughout the trial.

Conditions

Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in LDL-C

  week 12

Secondary Outcomes (9)

• Proportion of participants with LDL-C of less than 2.6 mmol/L

  week 12

• Proportion of participants with LDL-C of less than 1.8 mmol/L

  week 12

• Proportion of participants with LDL-C reduction of ≥50% from baseline

  week 12

• Change from baseline in LDL-C

  week 12

• Change and percentage change from baseline in non-HDL-C

  week 12

Study Arms (4)

IBI306 150 mg Q2W

EXPERIMENTAL

Drug: IBI306

Placebo Q2W

PLACEBO COMPARATOR

Drug: placebo

IBI306 450 mg Q4W

EXPERIMENTAL

Drug: IBI306

Placebo Q4W

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

Placebo Q2W

Placebo Q2W

IBI306 DRUG

IBI306 150 mg Q2W

IBI306 150 mg Q2W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥18 and ≤75 years of age on the day of signing informed consent.
• Fasting LDL-C ≥ 2.6 mmol/L and \< 4.9 mmol/L measured in a local laboratory at screening and randomization.
• Fasting triglyceride (TG) ≤ 5.64 mmol/L measured in a local laboratory at screening and randomization.
• According to the 2023 Chinese Guidelines for the Management of Blood Lipids, the 10-year risk of atherosclerotic cardiovascular disease is assessed as low or moderate (\< 10%).
• Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• \. History of any of the following medical or treatment conditions:
• Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.
• Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc.
• Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.
• History of acute or chronic heart failure with New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction \< 40% within 3 months prior to screening.
• Previous diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, or supraventricular tachycardia poorly controlled by medication, etc.
• Poorly controlled hypertension, defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or randomization.
• Previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, and other diseases that significantly affect blood lipid levels.
• History of type 1 diabetes mellitus, or type 2 diabetes mellitus with one of the following: (1) glycosylated hemoglobin (HbA1c) ≥ 8.5% at screening; (2) severe hypoglycemia within 6 months prior to screening; (3) insulin injection ≥ 2 times per day prior to screening.
• History of malignancy within 5 years prior to screening.
• Treatment with a PCSK9 monoclonal antibody within 6 months prior to screening or treatment with inclisiran prior to screening.
• Participation in a clinical study of any medical device or other drug within 3 months prior to screening (except for screening failure), or less than 5 half-lives from the most recent dose of the investigational drug at screening.
• Treatment with systemic cyclosporine within 3 months prior to screening.
• Long-term continuous (≥ 7 days) or multiple (≥ 3 times) systemic glucocorticoid therapy within 3 months prior to screening (except for topical, intraocular, intranasal, inhaled, or intra-articular injection).
• Treatment with weight-loss drugs or bariatric surgery within 3 months prior to screening.

Sponsors & Collaborators

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

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yida Tang

CONTACT

010-82266699; tang_yida@163.com

Study Design

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

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)