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IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

NCT07473960 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DRUG

IBI306

IBI306 150 mg Q2W

DRUG

placebo

Placebo Q2W

DRUG

placebo

Placebo Q4W

DRUG

IBI306

IBI306 450 mg Q4W

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-09-06
Completion
2027-02-28

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07473960 on ClinicalTrials.gov