Sponsor: NGM Biopharmaceuticals, Inc (industry)
Phase: 2
Start date: June 24, 2025
Planned enrollment: 136
NGM120 is an investigational antibody being studied for cancer-related cachexia (weight and muscle loss). Early trials also examined whether it could improve cancer outcomes. A randomized phase 2 trial in people with colorectal cancer and cachexia is recruiting; it has not posted results. (aacrjournals.org)
NGM120 blocks GFRAL, the receptor for growth differentiation factor 15 (GDF15). This is intended to interrupt GDF15 signaling implicated in appetite suppression and weight loss. (aacrjournals.org)
In a small phase 1b pancreatic-cancer cohort, NGM120 was given with gemcitabine and nab-paclitaxel. Three of eight treated patients had a partial tumor response; among the six evaluable patients, three had a partial response and three had stable disease. Five of those six maintained or gained body weight and lean body mass. Because the cohort was small and lacked a control group, these findings cannot establish how much, if any, benefit came from NGM120 rather than chemotherapy. A subsequent trial record includes a randomized placebo-controlled pancreatic-cancer cohort, but the early response figures should not be read as a comparative result. (aacrjournals.org)
The phase 1b abstract reported no dose-limiting toxicities in the eight pancreatic-cancer patients. Two stopped treatment before their first follow-up scan because of toxicity attributed to chemotherapy, not NGM120. These limited data cannot establish NGM120’s safety profile. (aacrjournals.org)
Last updated: Sep 2026
Goal: Assess whether NGM120 improves body weight in people with colorectal cancer and cancer cachexia, and evaluate its safety and tolerability.
Patients: Adults with active colorectal cancer and weight loss meeting Fearon criteria for cachexia. People with a reversible cause of reduced food intake, tube feeding or parenteral nutrition, or cachexia from another cause are excluded.
Design: Multicenter, randomized, double-blind, placebo-controlled phase 2 trial with five treatment groups.
Treatments: Participants receive subcutaneous low-dose NGM120 every 4 weeks, high-dose NGM120 every 4 or 8 weeks, or placebo every 4 weeks. NGM120 is an investigational antibody that blocks GFRAL, the receptor for GDF15, to interrupt signaling implicated in appetite suppression and weight loss. In a small, uncontrolled pancreatic cancer cohort receiving chemotherapy, some patients maintained or gained weight and lean body mass, but those findings cannot establish a benefit from NGM120. This colorectal cancer trial has not reported results.
Outcomes: Primary measures are change in body weight from baseline to week 12 and treatment-emergent adverse events through 44 weeks, including their frequency, severity, timing, seriousness, and relationship to treatment.
Burden on patient: Estimated moderate burden: subcutaneous treatment requires visits every 4 or 8 weeks, with weight assessments and safety follow-up extending up to 44 weeks. No mandatory biopsies or intensive pharmacokinetic blood sampling are specified, so the main additional demands appear to be treatment visits and monitoring.
Last updated: Sep 2026
Inclusion Criteria:
1. Documented active diagnosis of colorectal cancer.
2. Cachexia defined by Fearon criteria of weight loss.
3. Signed informed consent.
Exclusion Criteria:
1. Current active reversible causes of decreased food intake.
2. Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
3. Have cachexia caused by other reasons.
Tbilisi, 159, Georgia
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Status: Recruiting
Tbilisi, 186, Georgia
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Status: Recruiting
Tbilisi, 159, Georgia
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Status: Recruiting
Tbilisi, 159, Georgia
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Status: Recruiting
Tbilisi, 159, Georgia
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Status: Recruiting
Incheon, 21565, South Korea
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Status: Recruiting
Goyang, 1048, South Korea
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Status: Recruiting
Goyang, 10326, South Korea
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Status: Recruiting
Suwon, 16247, South Korea
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Status: Recruiting
Seoul, 6351, South Korea
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Status: Recruiting
Seoul, 3080, South Korea
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Status: Recruiting
Seoul, 2841, South Korea
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Status: Recruiting
Taoyuan District, 333423, Taiwan
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Status: Recruiting
Taichung, 407216, Taiwan
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Status: Recruiting
Taipei, 100225, Taiwan
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Status: Recruiting
Santa Rosa, California, 95403, United States
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Status: Recruiting
Los Angeles, California, 90095, United States
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Status: Recruiting
Los Angeles, California, 90033, United States
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Status: Recruiting
Margate, Florida, 33063, United States
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Status: Recruiting
Baltimore, Maryland, 21201, United States
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Status: Recruiting
New York, New York, 10065, United States
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Status: Recruiting
Toledo, Ohio, 43608, United States
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Status: Recruiting
Youngstown, Ohio, 44504, United States
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Status: Recruiting
Laredo, Texas, 78041, United States
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Status: Recruiting
Dallas, Texas, 75390, United States
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Status: Recruiting
Richmond, Virginia, 23114, United States
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Status: Recruiting
Appleton, Wisconsin, 54915, United States
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Status: Recruiting
Kingwood, Texas, 77339, United States
No email / No phone
Status: Withdrawn