Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| XC45544 | Other Identifier | Roche Protocol Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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 who are overweight or obese with Type 2 diabetes mellitus (T2DM).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Placebo | Placebo Comparator |
| |
| Arm 2: Enicepatide Dose Level 1 (Low) | Experimental |
| |
| Arm 3: Enicepatide Dose Level 2 | Experimental |
| |
| Arm 4: Enicepatide Dose Level 3 | Experimental |
| |
| Arm 5: Enicepatide Dose Level 4 (High) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will be volume-matched and administered subcutaneously (SC) once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight from Baseline to Week 36 | Baseline to Week 36 | |
| Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36 | Baseline to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight from Baseline to Week 48 | Baseline to Week 48 | |
| Change in HbA1c from Baseline to Week 48 | Baseline to Week 48 | |
| Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Carmot Therapeutics, Inc., a Member of the Roche Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209-8401 | United States | ||
| University of Alabama at Birmingham (UAB) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enicepatide | Drug | Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen. |
|
|
| Weeks 36 and 48 |
| Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36 | Baseline and Week 36 |
| Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48 | Baseline and Week 48 |
| Percent Change in Body Weight from Baseline to Week 28 | Baseline and Week 28 |
| Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48 | Baseline to Weeks 36 and 48 |
| Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class | Baseline to Weeks 16, 28, 36, and 48 |
| Change in HbA1c from Baseline to Weeks 16 and 28 | Baseline to Weeks 16 and 28 |
| Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class | Baseline to Weeks 16, 28, 36, and 48 |
| Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48 | Weeks 16, 28, 36, and 48 |
| Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48 | Weeks 16, 28, 36, and 48 |
| Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48 | Weeks 16, 28, 36, and 48 |
| Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48 | Baseline, Weeks 16, 28, 36, and 48 |
| Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48 | Baseline, Weeks 16, 28, 36, and 48 |
| Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48 | Baseline, Weeks 36 and 48 |
| Change in Waist Circumference from Baseline to Weeks 36 and 48 | Baseline, Weeks 36 and 48 |
| Change in Hip Circumference from Baseline to Weeks 36 and 48 | Baseline, Weeks 36 and 48 |
| Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48 | Baseline, Weeks 36 and 48 |
| Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48 | Baseline, Weeks 36 and 48 |
| Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48 | Baseline to Weeks 16, 28, 36, and 48 |
| Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48 | Baseline to Weeks 16, 28, 36, and 48 |
| Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48 | Baseline to Weeks 16, 28, 36, and 48 |
| Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48 | Baseline to Weeks 16, 28, 36, and 48 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Lakeview Clinical Research, LLC | Guntersville | Alabama | 35976 | United States |
| Yuma Clinical Trials | Yuma | Arizona | 85364 | United States |
| AMCR Institute | Escondido | California | 92025 | United States |
| Ark Clinical-Fountain Valley | Fountain Valley | California | 92708 | United States |
| Orange Country Research Center | Lake Forest | California | 92630 | United States |
| Ark Clinical Research | Long Beach | California | 90806 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Asclepes Research Centers | Sherman Oaks | California | 91403 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Flourish Research - Boca Raton | Boca Raton | Florida | 33434 | United States |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | United States |
| K2 Medical Research, LLC - Maitland | Maitland | Florida | 32751 | United States |
| K2 Medical Research, LLC - Orlando | Maitland | Florida | 32751 | United States |
| Flourish Research Acquisition, LLC | Miami | Florida | 33138 | United States |
| K2 Medical Research, LLC - South Orlando | Orlando | Florida | 32806 | United States |
| Aging Well Associates | St. Petersburg | Florida | 33713 | United States |
| K2 Medical Research Tampa | Tampa | Florida | 33607 | United States |
| K2 Summit Research | The Villages | Florida | 32159 | United States |
| Privia Medical Group Georgia, LLC | Fayetteville | Georgia | 30214 | United States |
| Privia Medical Group Georgia - Thomasville | Thomasville | Georgia | 31792 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Duly Health and Care | Lombard | Illinois | 60148 | United States |
| McFarland Clinic | Ames | Iowa | 50010 | United States |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| NOLA Cares, LLC | Metairie | Louisiana | 70006 | United States |
| Flourish Research Acquisition, LLC dba Flourish Bowie | Bowie | Maryland | 20715 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| NECCR PrimaCare Research LLC | Fall River | Massachusetts | 02721 | United States |
| Olive Branch Family Medical Center; Family Medicine | Olive Branch | Mississippi | 38654 | United States |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Ellipsis Research Group | Brooklyn | New York | 11215 | United States |
| Accellacare of Cary | Cary | North Carolina | 27518 | United States |
| Accellacare - Hickory | Hickory | North Carolina | 28601 | United States |
| Accellacare of Rocky Mount | Rocky Mount | North Carolina | 27804 | United States |
| Accellacare of Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| Accellacare of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Accellacare Research of Winston Salem | Winston-Salem | North Carolina | 27103 | United States |
| Diabetes and Endocrinology Associates of Stark County, Inc. | Canton | Ohio | 44718 | United States |
| Tekton Research | Edmond | Oklahoma | 73013 | United States |
| Roper St. Francis Physician Partners - Primary Care | Mt. Pleasant | South Carolina | 29464 | United States |
| Norwood Family Medicine | Knoxville | Tennessee | 37912 | United States |
| Summit-Halls Family Practice | Knoxville | Tennessee | 37938 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Velocity Clinical Research - Dallas | Dallas | Texas | 75230 | United States |
| University of Texas Southwestern Medical Center Investigation Drug Services | Dallas | Texas | 75390 | United States |
| Juno Research, LLC | Houston | Texas | 77040 | United States |
| Consano Clinical Research | Shavano Park | Texas | 78231 | United States |
| Privia Medical Group North Texas - Stephenville | Stephenville | Texas | 76401 | United States |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| Centro Medico Viamonte SRL | Buenos Aires | Provincia de Buenos | 1120 | Argentina |
| Centricity Research Brampton Endocrinology | Brampton | Ontario | L6S 0C6 | Canada |
| Aggarwal and Associates | Brampton | Ontario | L6T 0G1 | Canada |
| CEMDEC S.A. de C.V. | Cuauhtémoc | 06100 | Mexico |
| Instituto de Diabetes Obesidad y Nutricion, SC | Cuernavaca | 62250 | Mexico |
| SINACOR | Culiacán | 80230 | Mexico |
| Centro De Investigacion En Artritis Y Osteopososis | Mexicali | 21200 | Mexico |
| Clinicos Asociados Bocm, S.C. | Mexico City | 03300 | Mexico |
| Medical Care and Research S.A de C.V | Mérida | 97070 | Mexico |
| Avant Santé Research Center | San Pedro Garza García | 66260 | Mexico |
| Sociedad de Metabolismo y Corazon S.C. | Veracruz | 91855 | Mexico |
| FAICIC S de R.L. de C.V | Veracruz | 91900 | Mexico |
| Optimal Clinical Trials - North | Rosedale | Auckland | 0632 | New Zealand |
| Momentum Pukekohe | Auckland | 2120 | New Zealand |
| Optimal Clinical Trials | Grafton | 1010 | New Zealand |
| Tauranga Hospital | Tauranga | 3110 | New Zealand |
| Momentum Wellington | Wellington | 6021 | New Zealand |
| ISIS Clinical Research Center | Guaynabo | 00970 | Puerto Rico |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided