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The primary objective of this trial is to evaluate the effect of oral ECC4703 on body weight reduction and in a sub-study on liver fat content as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 20.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ECC4703 + semaglutide | Experimental | ECC4703 orally QD + semaglutide SC once weekly |
|
| Arm 2: Placebo + semaglutide | Placebo Comparator | Placebo orally QD + semaglutide SC once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECC4703 | Drug | orally QD |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Body Weight from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | |
| Proportion of Participants Achieving ≥5% Reduction in Body Weight from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 | |
| Absolute Change in Liver Fat Content as Measured by MRI-PDFF in Participants With Hepatic Steatosis | Baseline (Week 9) to Week 20 | |
| Percentage Change in Liver Fat Content as Measured by MRI-PDFF in Participants With Hepatic Steatosis | Baseline (Week 9) to Week 20 | |
| Proportion of Participants With ≥30% Relative Reduction in Liver Fat Content as Measured by MRI-PDFF | Baseline (Week 9) to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage Lean Mass as Measured by DXA | Baseline (Week 9) to Week 20 | |
| Change in Percentage Total Body Fat Mass as Measured by DXA | Baseline (Week 9) to Week 20 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates - Flourish - PPDS | Birmingham | Alabama | 35205 | United States | ||
| Anaheim Clinical Trials LLC - Anaheim - CenExel - PPDS |
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| Drug |
orally QD |
|
| Semaglutide | Drug | SC once weekly |
|
| Change in Percentage Visceral Fat Mass as Measured by DXA |
| Baseline (Week 9) to Week 20 |
| Change in Glycemic Parameters from Baseline (Week 9) to Week 20 | Change in HbA1c and fasting plasma glucose levels from baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Change in Lipid Parameters from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Change in Body Weight (kg) from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Proportion of Participants Achieving ≥2% and ≥3% Reduction in Body Weight from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Change in Alanine Aminotransferase (ALT) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Change in Aspartate Aminotransferase (AST) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Change in Alkaline Phosphatase (ALP) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Change in Gamma-Glutamyl Transferase (GGT) Levels from Baseline (Week 9) to Week 20 | Baseline (Week 9) to Week 20 |
| Frequency of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose through Week 20 (or end of study visit) |
| Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose through Week 20 (or end of study visit) |
| Laboratory Safety Evaluations | changes in clinical laboratory parameters, including hematology, serum chemistry, and urinalysis. | Baseline through Week 20 |
| Changes in 12-Lead Electrocardiogram (ECG) Parameters | Change in QT Interval, etc | Baseline through Week 20 |
| Changes in Vital Signs Findings | including blood pressure, etc | Baseline through Week 20 |
| Changes in Physical Examination Findings | including blood pressure, etc | Baseline through Week 20 |
| Anaheim |
| California |
| 92081 |
| United States |
| Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS | Los Alamitos | California | 90720 | United States |
| AES - DRS - Optimal Research Florida - Melbourne | Melbourne | Florida | 32934 | United States |
| ForCare Clinical Research - CenExel FCR - PPDS | Tampa | Florida | 33613 | United States |
| Atlanta Center for Medical Research - CenExel ACMR - PPDS | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta - CenExel - PPDS | Decatur | Georgia | 30030 | United States |
| AES - DRS - Synexus Clinical Research US, Inc. - Richfield - Minneapolis | Richfield | Minnesota | 55423 | United States |
| Velocity Clinical Research (3345 N 107th St) - Omaha - Nebraska - PPDS | Omaha | Nebraska | 68134 | United States |
| Velocity Clinical Research - Durham - PPDS | Durham | North Carolina | 27701 | United States |
| Velocity Clinical Research - Cincinnati (Springdale) - Ohio - PPDS | Cincinnati | Ohio | 45246 | United States |
| Velocity Clinical Research - Providence - PPDS | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research - Dallas - PPDS | Dallas | Texas | 75230 | 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 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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