About this trial
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented active diagnosis of colorectal cancer.
Cachexia defined by Fearon criteria of weight loss.
Signed informed consent.
Disqualifiers
Current active reversible causes of decreased food intake.
Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
Have cachexia caused by other reasons.
Trial design
Parallel
Treatments tested in this trial
NGM120 Q4W
DrugNGM120 given subcutaneously every 4 weeks
NGM120 Q8W
DrugNGM120 given subcutaneously every 8 weeks
Placebo given
DrugPlacebo given subcutaneously every 4 weeks
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in body weight at Week 12
To evaluate the effect of NGM120 compared to placebo on body weight.
Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
To evaluate safety and tolerability of NGM120
Sponsors and contacts
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