A Study of RGT001-075 in Adult Patients With Obesity
- Registration Number
- NCT06277934
- Lead Sponsor
- Regor Pharmaceuticals Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- Age ≥ 18 and ≤ 75 years
- Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
- Have had a stable body weight for the 3 months prior to randomization
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
- Have a prior or planned surgical treatment for obesity
- Have or plan to have endoscopic and/or device-based therapy for obesity
- Have any prior diagnosis of diabetes
- Have an electrocardiogram (ECG) with abnormalities
- Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
- Have a history of suicide attempt.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RGT001-075 Group RGT001-075 Patients will receive once daily dose of study drug for a total of 12 weeks Placebo Group Placebo Patients will receive once daily dose of matching placebo for a total of 12 weeks
- Primary Outcome Measures
Name Time Method 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 14 weeks
- Secondary Outcome Measures
Name Time Method RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf) 12 weeks Analysis of AUC0-inf
Change in waist circumference in centimetre 12 weeks Change in waist circumference from baseline at Week 12 .
Percent change in body weight 12 weeks Percent change in body weight from baseline at Week 12
Change in body weight in kilogram 12 weeks Change in body weight from baseline at Week 12
Percentage of participants who achieve ≥5% and ≥10% body weight reduction 12 weeks Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12
Change in Body mass index (BMI) in kg/m^2 12 weeks Change in BMI from baseline at Week 12
RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last) 12 weeks Analysis of AUC0-last
RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax) 12 weeks Analysis of Cmax
RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax) 12 weeks Analysis of Tmax
RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2) 12 weeks Analysis of t1/2
Trial Locations
- Locations (1)
Velocity Clinical Research
🇺🇸West Jordan, Utah, United States