This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study: * To evaluate the efficacy of different dose levels of CX11 tablets in body weight reduction as compared to placebo. * To compare the changes of effects in weight and weight-related indicators at the visit time points. * To evaluate the tolerability and safety of different doses of CX11 tablets in overweight/obese participants. * To assess the pharmacokinetics (PK) of different doses of CX11 tablets in overweight/obese participants. Overweight/obese participants who are successfully screened will be randomized in a 1:1:1:1:1 ratio to different doses of CX11 tablets or placebo. All participants will enter a 2-week follow-up period after 36 weeks of treatment for safety observation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
CX11 tablets administered orally once daily (QD) with meals
Matching placebo tablets administered orally once daily (QD) with meals
AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central
Phoenix, Arizona, United States
310 Clinical Research - Alliance Clinical - Los Angeles
Inglewood, California, United States
Acclaim Clinical Research - Alliance Clinical - San Diego
San Diego, California, United States
Angels Clinical Research Institute - Miami
Doral, Florida, United States
AES - DRS - Optimal Research Florida - Melbourne
Melbourne, Florida, United States
Angels Clinical Research Institute
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Oceanic Research Group, LLC
North Miami Beach, Florida, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
Savannah, Georgia, United States
Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS
Thomasville, Georgia, United States
...and 7 more locations
Percentage change in body weight from baseline
Time frame: At Week 26
Proportion of participants achieving ≥ 5% body weight reduction from baseline
Time frame: At Week 26
Percentage change in body weight from baseline
Time frame: At Week 36
Proportion of participants achieving ≥ 5% body weight reduction from baseline
Time frame: At Week 36
Proportion of participants achieving ≥ 10% body weight reduction from baseline
Time frame: At Week 26 and Week 36
Change in body weight from baseline
Time frame: At Week 26 and Week 36
Change in waist circumference from baseline
Time frame: At Week 26 and Week 36
Change in body mass index (BMI) from baseline
Time frame: At Week 26 and Week 36
Number of adverse events (AEs)
Time frame: Study duration, approximately 38 weeks
Number of treatment-emergent adverse events (TEAEs)
Time frame: Study duration, approximately 38 weeks
Number of AE of special interest (AESI)
Time frame: Study duration, approximately 38 weeks
Number of serious adverse events (SAEs)
Time frame: Study duration, approximately 38 weeks
Columbia-Suicide Severity Rating Scale [C-SSRS]
Higher scores on the C-SSRS indicate a worse outcome, as they reflect greater severity of suicidal ideation and behavior. The scale begins at 0 and there is no single maximum value as the scale consists of multiple items that assess different aspects of suicidal ideation and behavior. Each item is scored individually, and the overall assessment is based on the combination of responses.
Time frame: At Day 1, Week 12, Week 26, Week 36 or at early termination (ET)
Patient Health Questionnaire-9 [PHQ-9]
Higher scores on the PHQ-9 indicate a worse outcome, as they reflect more severe depression. The minimum score of the PHQ-9 is 0 and the maximum score of the PHQ-9 is 27.
Time frame: At Day 1, Week 12, Week 26, Week 36 or at ET
Maximum steady-state plasma concentration (Cmax,ss)
Time frame: Day 1 through Week 26
Minimum steady-state plasma concentration (Cmin,ss)
Time frame: Day 1 through Week 26
Time to maximum steady-state plasma concentration (Tmax,ss)
Time frame: Day 1 through Week 26
Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss)
Time frame: Day 1 through Week 26
Area under the concentration-time curve over the dosing interval (AUC0-tau)
Time frame: Day 1 through Week 26
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