A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia

Sponsor
Luye Pharma Group Ltd.
Study ID
NCT07396870
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • LY03020 — DRUG
    administered orally
  • Placebo — DRUG
    administered orally

Study Details

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with schizophrenia.

Key Dates

First listed
Feb 9, 2026
Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY03020
    Subjects will take LY03020 from Day 1 to Day 48
  • Placebo Comparator: Placebo
    Subjects will take Placebo from Day 1 to Day 48

Primary Outcome Measure

Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: baseline to week 6 of maintenance treatment ]

Central Contacts

Find similar trials

Nationwide
Schizophrenia trialsPsychiatry trialsMental health trialsBehavioral health trials

Related Studies