protocolSection identificationModule nctId: NCT06282458, orgStudyIdInfo id: V2000101, briefTitle: Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Veru Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists., conditionsModule conditions: Muscle Loss, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study.The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double Blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Enobosarm, interventions name: Semaglutide, outcomesModule primaryOutcomes measure: The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days., secondaryOutcomes measure: The percent change from baseline in total fat mass, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pinnacle Trials, city: Anniston, state: Alabama, zip: 36207, country: United States, contacts name: April Bolt, role: CONTACT, phone: 256-460-6379, email: Abolt@Pinnacletrials.com, contacts name: Almena Free, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.65983, lon: -85.83163, locations facility: Cullman Clinical Trials, city: Cullman, state: Alabama, zip: 35055, country: United States, contacts name: Cheryl Hargrove, role: CONTACT, phone: 256-708-2826, email: cheryl@cullmanclinicaltrials.com, contacts name: Randall Quinn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17482, lon: -86.84361, locations facility: Velocity Clinical Research, CA, city: Los Angeles, state: California, zip: 90057, country: United States, contacts name: Jenny Francisco, role: CONTACT, phone: 213-413-2500, email: JFrancisco@velocityclinical.com, contacts name: David Guzman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Artemis Institute for Clinical Research, city: San Diego, state: California, zip: 92103, country: United States, contacts name: Analicia Murillo, role: CONTACT, phone: 858-867-3557, email: analicia.murillo@artemis-research.com, contacts name: Stacy Layle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Universal Axom Clinical Research, city: Doral, state: Florida, zip: 33122, country: United States, contacts name: Diana Marinez, role: CONTACT, phone: 305-677-9267, phoneExt: 24, email: Dmarinez@uaclinical.com, contacts name: Luis Martinez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.81954, lon: -80.35533, locations facility: Altus Research, city: Lake Worth, state: Florida, zip: 33461, country: United States, contacts name: Junieth Leyes, role: CONTACT, phone: 561-641-0404, email: jleyes@altusresearch.com, contacts name: Samuel Lederman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.61708, lon: -80.07231, locations facility: MARC Research Center, city: Louisville, state: Kentucky, zip: 40213, country: United States, contacts name: Laken Heitz, role: CONTACT, phone: 502-214-3925, email: lheitz@lmarc.com, contacts name: Harold Bays, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Pennington Biomedical, city: Baton Rouge, state: Louisiana, zip: 70810, country: United States, contacts name: Aubrey Windham, role: CONTACT, phone: 225-763-2618, email: aubrey.windham@pbrc.edu, contacts name: Steven Heysmfield, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.45075, lon: -91.15455, locations facility: DelRicht Research - New Orleans, city: New Orleans, state: Louisiana, zip: 70115, country: United States, contacts name: Emily Krambeck, role: CONTACT, phone: 504-336-2667, email: ekrambeck@delricht.com, contacts name: Patrick Dennis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Centennial Medical Group (CMG), city: Elkridge, state: Maryland, zip: 21075, country: United States, contacts name: Tyler Stine, role: CONTACT, phone: 443-698-8678, email: TSTINE@centennialmedical.com, contacts name: Steven Geller, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.21261, lon: -76.71358, locations facility: SKY Integrative Medical Center, city: Ridgeland, state: Mississippi, zip: 39157, country: United States, contacts name: Bob Hutchins, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.42848, lon: -90.13231, locations facility: Clinvest Headlands LLC, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Kealon Cox, role: CONTACT, phone: 417-883-7889, email: kealon.cox@clinvest.com, contacts name: David True, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Palm Research Center, city: Las Vegas, state: Nevada, zip: 89119, country: United States, contacts name: Sasha Sandry, role: CONTACT, phone: 702-736-5161, email: sasha@palmresearchcenter.com, contacts name: Samer Nakhle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Lillestol Research LLC, city: Fargo, state: North Dakota, zip: 58104, country: United States, contacts name: Michael Lillestol, role: CONTACT, phone: 701-232-7705, email: lillestolmd@lillestolresearch.com, contacts name: Michael Lillestol, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87719, lon: -96.7898, hasResults: False