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
NGM Biopharmaceuticals, Inc
Summary
A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.
Description
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugNGM120 Q4W
NGM120 given subcutaneously every 4 weeks
- DrugNGM120 Q8W
NGM120 given subcutaneously every 8 weeks
- DrugPlacebo given
Placebo given subcutaneously every 4 weeks
Locations (28)
- NGM Clinical Study SiteLos Angeles, California
- NGM Clinical Study SiteLos Angeles, California
- NGM Clinical Study SiteSanta Rosa, California
- NGM Clinical Study SiteMargate, Florida
- NGM Clinical Study SiteBaltimore, Maryland
- NGM Clinical Study SiteNew York, New York