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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Petrelintide Dose 1 | Experimental | Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 1. |
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| Treatment B: Petrelintide Placebo Dose 1 | Placebo Comparator | Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. |
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| Treatment C: Petrelintide Dose 2 | Experimental | Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 2. |
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| Treatment D: Petrelintide Placebo Dose 2 | Placebo Comparator | Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. |
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| Treatment E: Petrelintide Dose 3 | Experimental | Randomized participants will receive weekly subcutaneous injections of petrelintide Dose 3. |
|
| Treatment F: Petrelintide Placebo Dose 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Petrelintide | Drug | Petrelintide will be taken by participants once weekly subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Body Weight | From Baseline (Day 1) to Weeks 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving ≥5% Body Weight Loss | From Baseline (Day 1) to Weeks 28 | |
| Number of Participants Achieving ≥10% Body Weight Loss | From Baseline (Day 1) to Weeks 28 | |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman Clinical Trials - Family Medicine | Cullman | Alabama | 35055 | United States | ||
| AZ Endocrine Institute |
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| Placebo Comparator |
Randomized participants will receive weekly subcutaneous injections of matching placebo to petrelintide. |
|
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| Placebo | Other | Matching placebo to petrelintide will be taken by participants once weekly subcutaneously. |
|
| Change in Body Weight (kilogram) |
| From Baseline (Day 1) to Weeks 28 |
| Change in Waist Circumference | From Baseline (Day 1) to Weeks 28 |
| Change in Glycated Hemoglobin (HbA1c) | From Baseline (Day 1) to Weeks 28 |
| Change in Fasting Glucose | From Baseline (Day 1) to Weeks 28 |
| Change in High-Sensitivity C-reactive protein (hsCRP) | From Baseline (Day 1) to Weeks 28 |
| Number of Participants Achieving ≤6.5% HbA1c | From Baseline (Day 1) to Weeks 28 |
| Changes in Fasting Lipids | From Baseline (Day 1) to Weeks 28 |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From Baseline (Day 1) to Weeks 38 |
| Number of Participants with Treatment- Emergent Severe or Clinically Significant Hypoglycemic Episodes from Baseline to Week 38 | From Baseline (Day 1) to Weeks 38 |
| Number of Participants with Positive Anti-Drug Antibodies (ADAs) | From Baseline (Day 1) to Weeks 38 |
| Change in Systolic Blood Pressure | From Baseline (Day 1) to Week 38 |
| Change in Diastolic Blood Pressure | From Baseline (Day 1) to Week 38 |
| Change in Pulse Rate | From Baseline (Day 1) to Week 38 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Elite Clinical Studies, LLC | Phoenix | Arizona | 85018 | United States |
| M3 Wake Research, Tucson Neuroscience Research, LLC | Tucson | Arizona | 85710 | United States |
| Medical Investigation Inc | Little Rock | Arkansas | 72211-1847 | United States |
| Velocity Clinical Research | Huntington Park | California | 90255 | United States |
| Velocity Clinical Research, North Hollywood | North Hollywood | California | 91606 | United States |
| Exalt Clinical Research | San Diego | California | 91910 | United States |
| Diablo Clinical Research Inc. | Walnut Creek | California | 94598 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Emerson Clinical Research | Washington D.C. | District of Columbia | 20009 | United States |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States |
| Solutions Through Advanced Research, Inc | Jacksonville | Florida | 32216 | United States |
| M3 Wake Research - Lake City | Lake City | Florida | 32055 | United States |
| West Orange Endocrinology P.A | Ocoee | Florida | 34761 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| M3 Wake Research - Atlanta | Atlanta | Georgia | 30328 | United States |
| East Coast Institute for Research - Canton | Canton | Georgia | 30114 | United States |
| Privia Medical Group Georgia, LLC | Savannah | Georgia | 31406 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Iowa Diabetes & Endocrinology Research Center | West Des Moines | Iowa | 50266 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| DelRicht Research - New Orleans | New Orleans | Louisiana | 70115 | United States |
| AAMRC | Flint | Michigan | 48504 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Velocity Clinical Research, Gulfport | Gulfport | Mississippi | 39503 | United States |
| AMR Kansas City | Kansas City | Missouri | 64114 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| M3 Wake Research - Las Vegas, NV | Las Vegas | Nevada | 89106 | United States |
| Palm Research Center, Inc. | Las Vegas | Nevada | 89148 | United States |
| Javara Inc | Charlotte | North Carolina | 28210 | United States |
| PharmQuest Life Sciences, LLC | Greensboro | North Carolina | 27408 | United States |
| M3 Wake Research | Raleigh | North Carolina | 27612 | United States |
| Velocity Clinical Research, Cincinnati, Mt. Auburn | Cincinnati | Ohio | 45219 | United States |
| Centricity Research | Columbus | Ohio | 43213 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73072 | United States |
| M3 Wake Research - Charleston | Charleston | South Carolina | 29414 | United States |
| M3 Wake Research/ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Elligo Clinical Research, Inc. | Austin | Texas | 78704 | United States |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8857 | United States |
| Juno Research LLC | Houston | Texas | 77040 | United States |
| Tekton Research, LLC | Irving | Texas | 75039 | United States |
| Tekton Research, LLC | McKinney | Texas | 75069 | United States |
| Texas Health Care, PLLC | San Marcos | Texas | 78666 | United States |
| Consano Clinical Research | Shavano Park | Texas | 78231 | United States |
| Texas Health Care | Stephenville | Texas | 76401 | United States |
| Manaasas Clinical Research Center | Manassas | Virginia | 20110 | United States |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| 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 |
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