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The primary objective of this study is to determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribupatide: Dose 1 | Experimental | Participants will receive Dose 1 of ribupatide once weekly. |
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| Ribupatide: Dose 2 | Experimental | Participants will receive Dose 2 of ribupatide once weekly. |
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| Ribupatide: Dose 3 | Experimental | Participants will receive Dose 3 of ribupatide once weekly. |
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| Ribupatide: Dose 4 | Experimental | Participants will receive Dose 4 of ribupatide once weekly. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to ribupatide once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribupatide | Drug | SC Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight at Week 48 | Baseline, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight | Baseline, Week 48 | |
| Change From Baseline in Waist Circumference | Baseline, Week 48 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kailera Clinical Site | Mesa | Arizona | 85213 | United States | ||
| Kailera Clinical Site |
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| Placebo | Drug | SC Injection |
|
| Change From Baseline in Absolute Body Weight |
| Baseline, Week 48 |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Triglycerides | Baseline, Week 48 |
| Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Non-HDL-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Total Cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol | Baseline, Week 48 |
| Percent Change From Baseline in Fasting Insulin | Baseline, Week 48 |
| Change From Baseline in Fasting Blood Glucose | Baseline, Week 48 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Week 52 |
| Number of Participants With Anti-drug Antibodies (ADAs) | Day 1 up to Week 52 |
| Number of Participants With Neutralizing Antibodies (NAbs) | Day 1 up to Week 52 |
| Plasma Concentrations of Ribupatide | Day 1 up to Week 52 |
| Sun City West |
| Arizona |
| 85375 |
| United States |
| Kailera Clinical Site | Irvine | California | 92614 | United States |
| Kailera Clinical Site | Lake Forest | California | 92630 | United States |
| Kailera Clinical Site | Lomita | California | 90717 | United States |
| Kailera Clinical Site | Long Beach | California | 90815 | United States |
| Kailera Clinical Site | Montclair | California | 91763 | United States |
| Kailera Clinical Site | Rolling Hills Estates | California | 90274 | United States |
| Kailera Clinical Site | San Diego | California | 92103 | United States |
| Kailera Clinical Site | Santa Ana | California | 92704 | United States |
| Kailera Clinical Site | Van Nuys | California | 91405 | United States |
| Kailera Clinical Site | DeLand | Florida | 32720 | United States |
| Kailera Clinical Site | Orlando | Florida | 32801 | United States |
| Kailera Clinical Site | Orlando | Florida | 32803 | United States |
| Kailera Clinical Site | The Villages | Florida | 32162 | United States |
| Kailera Clinical Site | Decatur | Georgia | 30030 | United States |
| Kailera Clinical Site | Woodstock | Georgia | 30189 | United States |
| Kailera Clinical Site | Morton | Illinois | 61550 | United States |
| Kailera Clinical Site | Indianapolis | Indiana | 46254 | United States |
| Kailera Clinical Site | Louisville | Kentucky | 40213 | United States |
| Kailera Clinical Site | Rockville | Maryland | 20852 | United States |
| Kailera Clinical Site | St Louis | Missouri | 63141 | United States |
| Kailera Clinical Site | Lincoln | Nebraska | 68516 | United States |
| Kailera Clinical Site | Omaha | Nebraska | 68144 | United States |
| Kailera Clinical Site | East Syracuse | New York | 13057 | United States |
| Kailera Clinical Site | Greensboro | North Carolina | 27405 | United States |
| Kailera Clinical Site | Monroe | North Carolina | 28112 | United States |
| Kailera Clinical Site | Raleigh | North Carolina | 27612 | United States |
| Kailera Clinical Site | Greenville | South Carolina | 29607 | United States |
| Kailera Clinical Site | Myrtle Beach | South Carolina | 29572 | United States |
| Kailera Clinical Site | Knoxville | Tennessee | 37909 | United States |
| Kailera Clinical Site | Memphis | Tennessee | 38119 | United States |
| Kailera Clinical Site | Garland | Texas | 75043 | United States |
| Kailera Clinical Site | San Antonio | Texas | 78215 | United States |
| Kailera Clinical Site | Winchester | Virginia | 22601 | 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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