> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/multicenter-study-to-assess-the-efficacy-and-safety-of-lb-07665538-bb3a-45a0-8eb0-b6e5b8be033e > Record changed: 2026-10-13 # Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE. NCT07494305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) Lead sponsor LB Pharmaceuticals Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) Start date 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) Number of sites 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Acronym** Illuminate1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Short title** Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Official title** A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Dates **Completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **First posted** 2026-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Registry last updated** 2026-07-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Primary completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Start date** 2026-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Number of sites** 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Lead sponsor** LB Pharmaceuticals Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Identifiers **Registry ID** NCT07494305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **ClinicalTrials.gov ID** NCT07494305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Double blind, randomized **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Outcomes ### Primary outcomes 1. Change From Baseline in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10) Timeframe: Baseline to Day 42 The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6\. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. ### Secondary outcomes 1. Incidence of Adverse Events Timeframe: Baseline to Day 56 Adverse Events (AEs) will be characterized by type, severity, seriousness, and relationship to treatment. All AEs will be coded using the most up-to-date version of the Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AE is the number and percentage of patients reporting the event at least once during the study, and will be counted only once per system organ class (SOC) and preferred term (PT). 2. Incidence of Treatment-emergent Mania based on the Young Mania Rating Scale (YMRS) Total Score Timeframe: Baseline Day 42 The Young Mania Rating Scale is a clinical assessment utilized to assess manic symptoms and their severity. The YMRS consists of 11 items, each focusing on a different aspect of mania. The total score can range from 0 to 60 with higher scores indicating more severe manic symptoms. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - Sign IRB approved ICF, Stable living environment - Diagnosis of Bipolar1 disorder defined by criteria in the DSM 5 and currently experiencing a MDE without psychotic or mixed features, and supported by the SCID 5 CT - Currently experiencing an MDE that began at least 4 weeks but no more than 18 months prior to randomization - Currently treated in an out-patient environment - MADRS 10 total score ≥24 at both Screening and Baseline with a difference of <20% in scores between visits. - Clinical Global Impression Scale, Bipolar Version Severity of Illness scale (CGI BP S) depression score ≥4 at both Screening and Baseline. - YMRS total score ≤12 at both Screening and Baseline. - Good physical health - BMI of ≥18 and ≤40 kg/m2. - Eligibility confirmed centrally for the severity, diagnosis, and treatment history by the SAFER interview. ### Exclusion criteria - Sexually active woman of childbearing potential and male who are not practicing 2 different methods of birth control or woman who is currently breast feeding - History of non-response to 2 adequate medication trials for depressive symptoms - Improvement of ≥20% in MADRS 10 total score between the screening and baseline assessments - Have bipolar disorder with mixed features or considered as rapid cyclers - Plan to initiate formal cognitive or behavioral therapy, systematic psychotherapy during the study, or plan to initiate such therapy during the study - History of disorders other than bipolar disorder, confirmed by previous psychiatric evaluation or the DSM 5 within 12 months prior to Screening - Experience of hallucinations, delusions, or any other psychotic symptomatology in the current MDE attributable to a primary DSM 5 diagnosis other than bipolar disorder. - Hospitalized for mania associated with Bipolar I Disorder within 30 days prior to Screening. Any previous manic phase must have completely resolved before enrollment in the study. - Significant risk for suicidal behavior during the study as determined by the Investigator's clinical assessment - Hypo or hyperthyroidism - Insulin dependent diabetes - Uncontrolled hypertension - Known significant cardiac disease - Laboratory results outside the defined protocol ranges - Clinically significant abnormal ECG findings - Received electroconvulsive therapy (ECT) within 90 days prior to Screening. - Received Transcranial Magnetic Stimulation within 90 days prior to Screening - Currently taking prohibited medications as defined in the protocol - History of non-response and/or responded only to ketamine, ECT or vagus nerve stimulation - Received GLP-1 within 30 of screening - History of organ disease that in the opinion of the PI would not make the patient eligible for participation Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Sites - Pillar Clinical ResearchBentonville, United StatesRecruiting - Pillar Clinical ResearchLittle Rock, United StatesRecruiting - CenExelBellflower, United StatesRecruiting - ProScience Research GroupCulver City, United StatesRecruiting - CenExelGarden Grove, United StatesRecruiting - Synergy San DiegoLemon Grove, United StatesRecruiting - NRC Research InstituteLos Angeles, United StatesRecruiting - NRC Research InstituteOrange, United StatesRecruiting - CenExelRiverside, United StatesRecruiting - CenExelTorrance, United StatesRecruiting - St. Jude Clinical ResearchDoral, United StatesRecruiting - Cenexel Hollywood FloridaHollywood, United StatesRecruiting - Innovative Clinical ResearchMiami Lakes, United StatesRecruiting - Health Synergy Clinical ResearchWest Palm Beach, United StatesRecruiting - TrialmedAtlanta, United StatesRecruiting - Cenexel Decatur GADecatur, United StatesRecruiting - Pillar Clinical ResearchChicago, United StatesRecruiting - NSRTDetroit, United StatesRecruiting - Arch Clinical TrialsSt Louis, United StatesRecruiting - Redbird ResearchLas Vegas, United StatesRecruiting - Manhattan Behavioral MedicineNew York, United StatesRecruiting - Neuro-Behavioral Clinical ResearchCanton, United StatesRecruiting - Adams ClinicalPhiladelphia, United StatesRecruiting - Adams ClinicalDeSoto, United StatesRecruiting - Pillar Clinical ResearchRichardson, United StatesRecruiting And 1 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07494305) ## Related records ### Drugs (1) - [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md) ### Lead sponsors (1) - [LB Pharmaceuticals Inc.](https://trialight.com/data/company/lb-pharmaceuticals-inc-c3e70f36-53ff-4a23-963c-4a3aae5159c5.md) ### Conditions (1) - [Bipolar I disorder](https://trialight.com/data/condition/bipolar-i-disorder-b1dec369-e9f7-586d-ad11-b8275f20481f.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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