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IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 14, 2026 (before its estimated September 6, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment closed, study ongoing Site details revised · Eligibility criteria expanded, about 5 wordsv3 Show 2 more changesShow less
    • Site details revised
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Recruitment opened Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07473960
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov