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A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia
Led by NGM Biopharmaceuticals, Inc · Updated on 2026-04-01
136
Participants Needed
28
Research Sites
34 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the effects of NGM120 in people with colorectal cancer who also have cancer cachexia, a condition involving significant weight loss. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess the safety, tolerability, and potential benefits of NGM120 in this population. Participants will receive either NGM120 or a placebo through subcutaneous injections. NGM120 is given in different dosing schedules: low dose every 4 weeks, high dose every 4 weeks, or high dose every 8 weeks. Placebo is administered every 4 weeks. These treatments will be compared to evaluate differences. Throughout the study, participants' body weight changes will be monitored for 12 weeks to assess treatment impact. Safety will be evaluated by tracking adverse events over 44 weeks. Participants will undergo regular assessments, including monitoring for treatment effects and side effects, with the total study duration extending up to 44 weeks.
CONDITIONS
Brief Title
An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented active diagnosis of colorectal cancer
- Cachexia defined by Fearon criteria of weight loss
- Signed informed consent
You will not qualify if you...
- Current active reversible causes of decreased food intake
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
- Cachexia caused by other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive NGM120 or placebo given subcutaneously at intervals of every 4 or 8 weeks depending on the treatment group.
Visits every 4 or 8 weeks during treatment
Trial Site Locations
Total: 28 locations
1
NGM Clinical Study Site
Los Angeles, California, United States, 90033
Actively Recruiting
2
NGM Clinical Study Site
Los Angeles, California, United States, 90095
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3
NGM Clinical Study Site
Santa Rosa, California, United States, 95403
Actively Recruiting
4
NGM Clinical Study Site
Margate, Florida, United States, 33063
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5
NGM Clinical Study Site
Baltimore, Maryland, United States, 21201
Actively Recruiting
6
NGM Clinical Study Site
New York, New York, United States, 10065
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7
NGM Clinical Study Site
Toledo, Ohio, United States, 43608
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8
NGM Clinical Study Site
Youngstown, Ohio, United States, 44504
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9
NGM Clinical Study Site
Dallas, Texas, United States, 75390
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10
NGM Clinical Study Site
Kingwood, Texas, United States, 77339
Withdrawn
11
NGM Clinical Study Site
Laredo, Texas, United States, 78041
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12
NGM Clinical Study Site
Richmond, Virginia, United States, 23114
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13
NGM Clinical Study Site
Appleton, Wisconsin, United States, 54915
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14
NGM Clinical Study Site
Tbilisi, Georgia, 159
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15
NGM Clinical Study Site
Tbilisi, Georgia, 159
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16
NGM Clinical Study Site
Tbilisi, Georgia, 159
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17
NGM Clinical Study Site
Tbilisi, Georgia, 159
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18
NGM Clinical Study Site
Tbilisi, Georgia, 186
Actively Recruiting
19
NGM Clinical Study Site
Goyang, South Korea, 10326
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20
NGM Clinical Study Site
Goyang, South Korea, 1048
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21
NGM Clinical Study Site
Incheon, South Korea, 21565
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22
NGM Clinical Study Site
Seoul, South Korea, 2841
Actively Recruiting
23
NGM Clinical Study Site
Seoul, South Korea, 3080
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24
NGM Clinical Study Site
Seoul, South Korea, 6351
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25
NGM Clinical Study Site
Suwon, South Korea, 16247
Actively Recruiting
26
NGM Clinical Study Site
Taichung, Taiwan, 407216
Actively Recruiting
27
NGM Clinical Study Site
Taipei, Taiwan, 100225
Actively Recruiting
28
NGM Clinical Study Site
Taoyuan, Taiwan, 333423
Actively Recruiting
Research Team
N
NGM Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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