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Bipolar I Disorder / LB-102 · Phase 2 Trial
ClinicalTrials.gov · July 27, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a trial registration for a Phase 2 randomized, placebo-controlled study evaluating LB-102 in adult patients with bipolar I disorder experiencing a major depressive episode. The study is currently recruiting with an estimated enrollment of 320 participants and 6 weeks of treatment, measuring change in MADRS-10 as the primary endpoint.
Randomized placebo-controlled interventional trial, 6 weeks duration. Adult patients with Bipolar I Disorder experiencing a major depressive episode. Intervention: LB-102. Compared with: Placebo — Placebo Comparator. n = 320. 26 sites: United States.
Estimated enrollment is 320 participants Phase 2 interventional study comparing LB-102 to placebo Primary outcome is change from baseline in MADRS-10 at Day 42
This is a registry record only; no efficacy or safety results are reported
This trial will provide Phase 2 efficacy and safety data for LB-102 as a potential treatment for bipolar I depression, a condition with significant unmet therapeutic needs. Clinicians should await publication of results before drawing conclusions about clinical utility.
Phase 2 trial registry record for LB-102 in bipolar I disorder major depressive episode; no results yet reported.
As stated by the source record.
Quoted from the source exactly as published.
This trial will provide Phase 2 efficacy and safety data for LB-102 as a potential treatment for bipolar I depression, a condition with significant unmet therapeutic needs. Clinicians should await publication of results before drawing conclusions about clinical utility.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07494305). This is a study registration, not published results. Lead sponsor: LB Pharmaceuticals Inc.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Bipolar I Disorder. Interventions: DRUG: LB-102; OTHER: Placebo. Primary outcome measures: Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10) , Baseline to Day 42. Brief summary: Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollment will be randomized (like flipping a coin) to either active drug (LB-102 or placebo). Treatment is for 6 weeks.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.