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This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator |
| |
| 120 mg group | Experimental |
| |
| 160 mg group | Experimental |
| |
| 200 mg fast titration group | Experimental |
| |
| 200 mg slow titration group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX11 | Drug | CX11 tablets administered orally once daily (QD) with meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight from baseline | At Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving ≥ 5% body weight reduction from baseline | At Week 26 | |
| Percentage change in body weight from baseline | At Week 36 | |
| Proportion of participants achieving ≥ 5% body weight reduction from baseline |
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Inclusion Criteria
Participants who meet all of the following criteria will be eligible to participate in this study:
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central | Phoenix | Arizona | 85020-4327 | United States | ||
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|
| Placebo | Other | Matching placebo tablets administered orally once daily (QD) with meals |
|
| 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] | 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. | 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. | At Day 1, Week 12, Week 26, Week 36 or at ET |
| 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 |
| 310 Clinical Research - Alliance Clinical - Los Angeles |
| Inglewood |
| California |
| 90301 |
| United States |
| Acclaim Clinical Research - Alliance Clinical - San Diego | San Diego | California | 92120 | United States |
| Angels Clinical Research Institute - Miami | Doral | Florida | 33122-1713 | United States |
| AES - DRS - Optimal Research Florida - Melbourne | Melbourne | Florida | 32934-8172 | United States |
| Angels Clinical Research Institute | Miami | Florida | 33126 | United States |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33014-2266 | United States |
| Oceanic Research Group, LLC | North Miami Beach | Florida | 33169 | United States |
| Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS | Savannah | Georgia | 31406-3928 | United States |
| Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS | Thomasville | Georgia | 31792-6618 | United States |
| Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS | Valparaiso | Indiana | 46383 | United States |
| Mankato Clinic - East Main Street - Javara - PPDS | Mankato | Minnesota | 56001 | United States |
| Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS | Cincinnati | Ohio | 45246-2316 | United States |
| Velocity Clinical Research - Dallas - PPDS | Dallas | Texas | 75230 | United States |
| Epic Clinical Research - Alliance Clinical - Lewisville | Lewisville | Texas | 75057 | United States |
| AES - DRS - Synexus Clinical Research US, Inc. - San Antonio | San Antonio | Texas | 78229 | United States |
| Flourish Research - San Antonio - PPDS | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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