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A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
Evaluation of Efficacy, Safety and Tolerability of NGM120 in a Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Participants with Colorectal Cancer who have Cancer Cachexia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM120 Treatment Group A | Experimental | NGM120 low dose given subcutaneously every 4 weeks |
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| NGM120 Treatment Group B | Placebo Comparator | Placebo low dose given subcutaneously every 4 weeks |
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| NGM120 Treatment Group C | Experimental | NGM120 high dose given subcutaneously every 4 weeks |
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| NGM120 Treatment Group D | Experimental | NGM120 high dose given subcutaneously every 8 weeks |
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| NGM120 Treatment Group E | Placebo Comparator | Placebo high dose given subcutaneously every 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM120 Q4W | Drug | NGM120 given subcutaneously every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight at Week 12 | To evaluate the effect of NGM120 compared to placebo on body weight. | 12 Weeks |
| Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug | To evaluate safety and tolerability of NGM120 | 44 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NGM Study Director | Contact | 650-727-8800 | NGM120CX@ngmbio.com |
| Name | Affiliation | Role |
|---|---|---|
| NGM Study Director | NGM Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Recruiting | Los Angeles | California | 90033 | United States |
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| NGM120 Q8W | Drug | NGM120 given subcutaneously every 8 weeks |
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| Placebo given | Drug | Placebo given subcutaneously every 4 weeks |
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| NGM Clinical Study Site | Recruiting | Los Angeles | California | 90095 | United States |
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| NGM Clinical Study Site | Recruiting | Santa Rosa | California | 95403 | United States |
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| NGM Clinical Study Site | Recruiting | Margate | Florida | 33063 | United States |
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| NGM Clinical Study Site | Recruiting | Baltimore | Maryland | 21201 | United States |
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| NGM Clinical Study Site | Recruiting | New York | New York | 10065 | United States |
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| NGM Clinical Study Site | Recruiting | Toledo | Ohio | 43608 | United States |
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| NGM Clinical Study Site | Recruiting | Youngstown | Ohio | 44504 | United States |
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| NGM Clinical Study Site | Recruiting | Dallas | Texas | 75390 | United States |
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| NGM Clinical Study Site | Withdrawn | Kingwood | Texas | 77339 | United States |
| NGM Clinical Study Site | Recruiting | Laredo | Texas | 78041 | United States |
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| NGM Clinical Study Site | Recruiting | Richmond | Virginia | 23114 | United States |
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| NGM Clinical Study Site | Recruiting | Appleton | Wisconsin | 54915 | United States |
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| NGM Clinical Study Site | Recruiting | Tbilisi | 159 | Georgia |
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| NGM Clinical Study Site | Recruiting | Tbilisi | 159 | Georgia |
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| NGM Clinical Study Site | Recruiting | Tbilisi | 159 | Georgia |
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| NGM Clinical Study Site | Recruiting | Tbilisi | 159 | Georgia |
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| NGM Clinical Study Site | Recruiting | Tbilisi | 186 | Georgia |
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| NGM Clinical Study Site | Recruiting | Goyang | 10326 | South Korea |
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| NGM Clinical Study Site | Recruiting | Goyang | 1048 | South Korea |
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| NGM Clinical Study Site | Recruiting | Incheon | 21565 | South Korea |
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| NGM Clinical Study Site | Recruiting | Seoul | 2841 | South Korea |
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| NGM Clinical Study Site | Recruiting | Seoul | 3080 | South Korea |
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| NGM Clinical Study Site | Recruiting | Seoul | 6351 | South Korea |
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| NGM Clinical Study Site | Recruiting | Suwon | 16247 | South Korea |
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| NGM Clinical Study Site | Recruiting | Taichung | 407216 | Taiwan |
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| NGM Clinical Study Site | Recruiting | Taipei | 100225 | Taiwan |
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| NGM Clinical Study Site | Recruiting | Taoyuan | 333423 | Taiwan |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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