Health TrialsbyHealthPanel

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

ConditionNon-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IBI306

    Drug

    IBI306 150 mg Q2W

  • placebo

    Drug

    Placebo Q2W

  • placebo

    Drug

    Placebo Q4W

  • IBI306

    Drug

    IBI306 450 mg Q4W

Treatment groups

198 Participants
are divided into 4 treatment groups
Group A: IBI306 150 mg Q2WExperimental treatment 1 intervention
Group B: Placebo Q2WPlacebo comparator 1 intervention
Group C: IBI306 450 mg Q4WExperimental treatment 1 intervention
Group D: Placebo Q4WPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in LDL-C

Time frame
week 12

Secondary outcomes

1

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

Time frame
week 12
2

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

Time frame
week 12
3

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

Time frame
week 12
4

Change from baseline in LDL-C

Time frame
week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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