protocolSection identificationModule nctId: NCT06303570, orgStudyIdInfo id: CBL-0202DD, briefTitle: A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-28, primaryCompletionDateStruct date: 2025-05-23, completionDateStruct date: 2025-05-23, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Caliway Biopharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas., conditionsModule conditions: Dercum's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CBL-514 injection, interventions name: 0.9% Sodium chloride, outcomesModule primaryOutcomes measure: To estimate the treatment effect, as measured by Complete Response (CR), between CBL-514 and placebo at Week 12 in participants with Dercum's disease (DD)., secondaryOutcomes measure: To estimate the treatment effect, as measured by pain, between CBL-514 and placebo at Week 12 in participants with DD., secondaryOutcomes measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To evaluate the treatment effect, as measured by change in volume, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24., secondaryOutcomes measure: To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol., secondaryOutcomes measure: To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False