protocolSection identificationModule nctId: NCT06277934, orgStudyIdInfo id: RGT001-075-203, briefTitle: A Study of RGT001-075 in Adult Patients With Obesity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Regor Pharmaceuticals Inc., class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: RGT001-075, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings, secondaryOutcomes measure: Percent change in body weight, secondaryOutcomes measure: Change in body weight in kilogram, secondaryOutcomes measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction, secondaryOutcomes measure: Change in Body mass index (BMI) in kg/m^2, secondaryOutcomes measure: Change in waist circumference in centimetre, secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax), secondaryOutcomes measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research, status: RECRUITING, city: Los Angeles, state: California, zip: 90057, country: United States, contacts name: David Guzman, MD, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Velocity Clinical Research, status: RECRUITING, city: Valparaiso, state: Indiana, zip: 46383, country: United States, contacts name: Robert Buynak, MD, role: CONTACT, geoPoint lat: 41.47309, lon: -87.06114, locations facility: Velocity Clinical Research, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68134, country: United States, contacts name: Frederick Raiser, MD, role: CONTACT, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Velocity Clinical Research, status: RECRUITING, city: Vestal, state: New York, zip: 13850, country: United States, contacts name: Eric Lorraine, MD, role: CONTACT, geoPoint lat: 42.08507, lon: -76.05381, locations facility: Velocity Clinical Research, status: RECRUITING, city: Durham, state: North Carolina, zip: 27701, country: United States, contacts name: William Cromwell, MD, role: CONTACT, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Velocity Clinical Research, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44122, country: United States, contacts name: Margaret Rhee, MD, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Velocity Clinical Research, status: RECRUITING, city: Medford, state: Oregon, zip: 97504, country: United States, contacts name: Sarah Smiley, MD, role: CONTACT, geoPoint lat: 42.32652, lon: -122.87559, locations facility: Velocity Clinical Research, status: RECRUITING, city: East Greenwich, state: Rhode Island, zip: 02818, country: United States, contacts name: David Fried, MD, role: CONTACT, geoPoint lat: 41.66038, lon: -71.45589, locations facility: Velocity Clinical Research, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Dan Lender, MD, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Velocity Clinical Research, status: RECRUITING, city: West Jordan, state: Utah, zip: 84088, country: United States, contacts name: Barbara Rizzardi, MD, role: CONTACT, geoPoint lat: 40.60967, lon: -111.9391, hasResults: False