nctId: NCT06277934 id: RGT001-075-203 briefTitle: A Study of RGT001-075 in Adult Patients With Obesity overallStatus: RECRUITING date: 2024-03-08 date: 2024-06 date: 2024-07 date: 2024-02-26 date: 2024-04-04 name: Regor Pharmaceuticals Inc. class: INDUSTRY 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. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: RGT001-075 name: Placebo 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 measure: Percent change in body weight measure: Change in body weight in kilogram measure: Percentage of participants who achieve ≥5% and ≥10% body weight reduction measure: Change in Body mass index (BMI) in kg/m^2 measure: Change in waist circumference in centimetre measure: RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) measure: RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) measure: RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) measure: RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) measure: RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research status: RECRUITING city: Los Angeles state: California zip: 90057 country: United States name: David Guzman, MD role: CONTACT lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research status: RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States name: Robert Buynak, MD role: CONTACT lat: 41.47309 lon: -87.06114 facility: Velocity Clinical Research status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States name: Frederick Raiser, MD role: CONTACT lat: 41.25626 lon: -95.94043 facility: Velocity Clinical Research status: RECRUITING city: Vestal state: New York zip: 13850 country: United States name: Eric Lorraine, MD role: CONTACT lat: 42.08507 lon: -76.05381 facility: Velocity Clinical Research status: RECRUITING city: Durham state: North Carolina zip: 27701 country: United States name: William Cromwell, MD role: CONTACT lat: 35.99403 lon: -78.89862 facility: Velocity Clinical Research status: RECRUITING city: Cleveland state: Ohio zip: 44122 country: United States name: Margaret Rhee, MD role: CONTACT lat: 41.4995 lon: -81.69541 facility: Velocity Clinical Research status: RECRUITING city: Medford state: Oregon zip: 97504 country: United States name: Sarah Smiley, MD role: CONTACT lat: 42.32652 lon: -122.87559 facility: Velocity Clinical Research status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: David Fried, MD role: CONTACT lat: 41.66038 lon: -71.45589 facility: Velocity Clinical Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Dan Lender, MD role: CONTACT lat: 32.78306 lon: -96.80667 facility: Velocity Clinical Research status: RECRUITING city: West Jordan state: Utah zip: 84088 country: United States name: Barbara Rizzardi, MD role: CONTACT lat: 40.60967 lon: -111.9391 hasResults: False