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| ID | Type | Description | Link |
|---|---|---|---|
| XC45526 | Other Identifier | Roche Protocol Number |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Placebo | Placebo Comparator | Placebo administered subcutaneously (SC) once weekly. |
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| Arm 2: Enicepatide Dose Level 1 (Low) | Experimental | Enicepatide Dose Level 1 administered SC once weekly. |
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| Arm 3: Enicepatide Dose Level 2 | Experimental | Enicepatide Dose Level 2 administered SC once weekly. |
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| Arm 4: Enicepatide Dose Level 3 | Experimental | Enicepatide Dose Level 3 administered SC once weekly. |
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| Arm 5: Enicepatide Dose Level 4 | Experimental | Enicepatide Dose Level 4 administered SC once weekly. |
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| Arm 6: Enicepatide Dose Level 5 (High) | Experimental | Enicepatide Dose Level 5 administered SC once weekly. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will be volume- matched and administered subcutaneously (SC) once weekly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight from Baseline to Week 48 | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 | Baseline and Week 48 | |
| Absolute Change in Body Weight (kg) from Baseline to Week 48 | Baseline to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Carmot Therapeutics, Inc., a Member of the Roche Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Central Alabama Research |
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| Enicepatide | Drug | Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen. |
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| Percent Change in Body Weight from Baseline to Week 48 by Obesity Class | Baseline to Week 48 |
| Change in Body Mass Index (BMI) from Baseline to Week 48 | Baseline to Week 48 |
| Change in Waist Circumference from Baseline to Week 48 | Baseline to Week 48 |
| Change in Hip Circumference from Baseline to Week 48 | Baseline to Week 48 |
| Change in Waist-to-Hip Ratio from Baseline to Week 48 | Baseline to Week 48 |
| Change in Waist-to-Height Ratio from Baseline to Week 48 | Baseline to Week 48 |
| Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting Plasma Glucose from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting Insulin from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting C-peptide from Baseline to Week 48 | Baseline to Week 48 |
| Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48 | Baseline to Week 48 |
| Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48 | Baseline to Week 48 |
| Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c | Baseline and Week 48 |
| Homewood |
| Alabama |
| 35209 |
| United States |
| The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health | Mesa | Arizona | 85210 | United States |
| Amicis Research Center - Anaheim | Anaheim | California | 92801 | United States |
| Ark Clinical-Fountain Valley | Fountain Valley | California | 92708 | United States |
| Ark Clinical Research - Long Beach | Long Beach | California | 90806 | United States |
| Velocity Clinical Research - Los Angeles | Los Angeles | California | 90057 | United States |
| Infinity Clinical Research | Norco | California | 92860 | United States |
| Amicis Research Center | Northridge | California | 91324 | United States |
| Prospective Research Innovations Inc. | Rancho Cucamonga | California | 91730 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Amicis Research Center - West Hills | West Hills | California | 91307 | United States |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Louisville Metabolic and Atherosclerosis Research Center (L-MARC) | Louisville | Kentucky | 40213 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Mercury Street Medical Group | Butte | Montana | 59701 | United States |
| Neurobehavioral Research, Inc. (NBR) | Cedarhurst | New York | 11516 | United States |
| Lucas Research, Inc | Morehead City | North Carolina | 28557 | United States |
| Velocity Clinical Research - Cincinnati | Cincinnati | Ohio | 45242 | United States |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | United States |
| Tribe Clinical Research | Greenville | South Carolina | 29607 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37920 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78731 | United States |
| Apex Mobile Clinical Research | Bellaire | Texas | 77401 | United States |
| Velocity Clinical Research - Dallas | Dallas | Texas | 75230 | United States |
| FutureSearch Trials of Dallas, LLC | Dallas | Texas | 75231 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| Elevate Clinical | Seabrook | Texas | 77586 | United States |
| Impact Research Institute | Waco | Texas | 76710 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| National Clinical Research - Richmond, Inc | Richmond | Virginia | 23294 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
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