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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-7968 | Other Identifier | Universal Trial Number |
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The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zenagamtide | Experimental | Participants will receive Zenagamtide and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Semaglutide dose 1 | Active Comparator | Participants will receive semaglutide dose 1 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Semaglutide dose 2 | Active Comparator | Participants will receive semaglutide dose 2 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenagamtide | Drug | Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%) change in body weight. | From week 0 to week 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Measured as centimetre (cm). | From week 0 to week 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Valley Medical Group | Lancaster | California | 93534 | United States | ||
| Desert Oasis Healthcare |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide | Drug | Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Placebo (matched to semaglutide) | Drug | Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Placebo (matched to zenagamtide) | Drug | Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Palm Springs |
| California |
| 92262 |
| United States |
| Western University of Health Sciences | Pomona | California | 91766 | United States |
| Artemis Insitute for Clin Res | San Diego | California | 92123 | United States |
| Med Home Development Grp | Washington D.C. | District of Columbia | 20037 | United States |
| Encore Medical Research LLC | Hollywood | Florida | 33024 | United States |
| NextPhase Research | Hollywood | Florida | 33024 | United States |
| Jacksonville Ctr Clin Res | Jacksonville | Florida | 32216 | United States |
| PharmaDev Clinical Research Institute LLC | Miami | Florida | 33176 | United States |
| South Broward Research LLC | Miramar | Florida | 33027 | United States |
| Essence MD Research | Naples | Florida | 34102 | United States |
| Florida Inst For Clin Res LLC | Orlando | Florida | 32825 | United States |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Encore Medical Research of Weston | Weston | Florida | 33331 | United States |
| Conquest Research | Atlanta | Georgia | 30328 | United States |
| Eastside Bariatric and Gen Surg | Snellville | Georgia | 30078 | United States |
| Chicago Research Center, Inc | Chicago | Illinois | 60634 | United States |
| Endeavor Health | Skokie | Illinois | 60077 | United States |
| Midwest Inst For Clin Res | Indianapolis | Indiana | 46260 | United States |
| Southern Clin Research | Zachary | Louisiana | 70791 | United States |
| Amicis Centers of Clinical Research | St Louis | Missouri | 63128 | United States |
| Ichor Research | Syracuse | New York | 13210 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Piedmont Healthcare/Research | Statesville | North Carolina | 28625 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | United States |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681-1538 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79124 | United States |
| Texas Diabetes & Endocrinology | Austin | Texas | 78749 | United States |
| Pinnacle Clinical Research | Brownsville | Texas | 78520 | United States |
| Osvaldo A. Brusco MD | Corpus Christi | Texas | 78414 | United States |
| UT Southwestern Med Center | Dallas | Texas | 75390 | United States |
| Epic Medical Research | DeSoto | Texas | 75115 | United States |
| Houston Research Institute | Houston | Texas | 77079 | United States |
| The Endocrine Center | Houston | Texas | 77079 | United States |
| Sleep Therapy Research Center | San Antonio | Texas | 78229 | United States |
| Olympus Clinical Research | Sugar Land | Texas | 77478 | United States |
| National Clin Res Inc. | Richmond | Virginia | 23294 | United States |
| Gastroent Consult of SW VA | Roanoke | Virginia | 24014 | United States |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | United States |
| Seattle Clinical Research Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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 |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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