This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
236
RGT001-075 is a small molecule GLP-1 agonist
Placebo comparator
Percent change from baseline in body weight at Week 36
Least Squares (LS) mean using mixed model repeated measures (MMRM)
Time frame: Baseline and 36 weeks
Percent change from baseline in body weight at Week 26
Least Squares (LS) mean using mixed model repeated measures (MMRM)
Time frame: Baseline and 26 weeks
Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall
To evaluate the safety and tolerability of RGT001-075 for weight loss in adults who are obese, or overweight with at least one weight-related comorbidity
Time frame: Baseline through week 36
Ambulatory Blood Pressure Monitoring (ABPM)
The ABPM device will be attached to the nondominant arm, and participants will be instructed to wear the monitor for a 24- to 27-hour period.
Time frame: Baseline, 26 weeks
AUC0-last
Area under the serum concentration curve from time-zero to the last quantifiable concentration of RGT001-075
Time frame: week 15
AUC0-inf
Area under curve from time zero to time infinite
Time frame: week 15
Cmax
Maximum concentration of RT001-075
Time frame: week15
Tmax
Time to achieve maximum concentration of RT001-075
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Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Synexus Clinical Research
Phoenix, Arizona, United States
Velocity Clinical Research
Huntington Park, California, United States
Angels Clinical Research
Doral, Florida, United States
Optimal Research
Melbourne, Florida, United States
Angels Clinical Research
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Synexus Clinical Research
The Villages, Florida, United States
Javara-Privia Medical Group, Georgia LLC
Savannah, Georgia, United States
Javara-Privia Medical Group, Georgia, LLC
Thomasville, Georgia, United States
...and 25 more locations
Time frame: week 15
t1/2
Terminal half-life of RGT001-075
Time frame: week 15