A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06046443

Title field or adapter rule

{'original_value': 'A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T01:06:25.686704+00:00

Published At

2026-10-30T00:00:00+00:00

Record Updated At

2026-10-30

Results Posted At

2026-10-30

Source Retrieved At

2026-10-31T01:06:25.053101+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Hypothalamic Obesity"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-30", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06046443"

protocolSection.identificationModule.officialTitle

"A Randomized, Placebo-controlled, Double-Blind Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity, With an Open-Label Extension"

protocolSection.statusModule.overallStatus

"COMPLETED"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2026-10-30", "type": "ACTUAL"}

Study condition terms

• Hypothalamic Obesity (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Bivamelagon High dose (600 mg)', 'Bivamelagon Low dose (200 milligrams [mg])', 'Bivamelagon Middle dose (400 mg)', 'Open-label Bivamelagon'], 'description': 'Oral daily administration', 'name': 'Bivamelagon', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Placebo'], 'description': 'Placebo matched to LB54640', 'name': 'Placebo', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• Bivamelagon (protocolSection.armsInterventionsModule.interventions[].name)
• Placebo (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

This index keeps the source fields it imported; it may not contain the complete original record. Verify wording and context in the linked source.