A Study to Evaluate the Efficacy and Safety of CX11 Tablets in Overweight/Obese Participants
- Registration Number
- NCT07011797
- Lead Sponsor
- Corxel Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo - 120 mg group CX11 - 160 mg group CX11 - 200 mg fast titration group CX11 - 200 mg slow titration group CX11 -
- Primary Outcome Measures
Name Time Method Percentage change in body weight from baseline At Week 26
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving ≥ 5% body weight reduction from baseline At Week 36 Percentage change in body weight from baseline At Week 36 Proportion of participants achieving ≥ 10% body weight reduction from baseline At Week 26 and Week 36 Change in body weight from baseline At Week 26 and Week 36 Change in waist circumference from baseline At Week 26 and Week 36 Change in body mass index (BMI) from baseline At Week 26 and Week 36 Number of adverse events (AEs) Study duration, approximately 38 weeks Number of treatment-emergent adverse events (TEAEs) Study duration, approximately 38 weeks Number of AE of special interest (AESI) Study duration, approximately 38 weeks Number of serious adverse events (SAEs) Study duration, approximately 38 weeks Columbia-Suicide Severity Rating Scale [C-SSRS] At Day 1, Week 12, Week 26, Week 36 or at early termination (ET) 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.
Patient Health Questionnaire-9 [PHQ-9] At Day 1, Week 12, Week 26, Week 36 or at ET 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.
Maximum steady-state plasma concentration (Cmax,ss) Day 1 through Week 26 Minimum steady-state plasma concentration (Cmin,ss) Day 1 through Week 26 Time to maximum steady-state plasma concentration (Tmax,ss) Day 1 through Week 26 Area under the curve from 0 h to the time of the last quantifiable concentration (AUC0-last,ss) Day 1 through Week 26 Area under the concentration-time curve over the dosing interval (AUC0-tau) Day 1 through Week 26
Trial Locations
- Locations (17)
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
Palm Springs Community Health Center
🇺🇸Miami Lakes, Florida, United States
Angels Clinical Research Institute
🇺🇸Miami, 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
Scroll for more (7 remaining)AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central🇺🇸Phoenix, Arizona, United States