NGM120 treatment for cachexia in colorectal cancer
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
This trial tests whether the drug NGM120 can help people with colorectal cancer who have cancer cachexia gain or maintain weight and improve symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NGM Biopharmaceuticals, Inc Industry-sponsored |
| Locations | 28 sites (Los Angeles, California and 27 other locations) |
| Trial ID | NCT07033026 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial testing NGM120 in people with colorectal cancer who have cancer cachexia. Participants are randomized to receive NGM120 every 4 weeks, NGM120 every 8 weeks, or placebo, with treatment and follow-up visits to measure efficacy, safety, and tolerability. Key eligibility includes an active diagnosis of colorectal cancer and cachexia defined by the Fearon criteria, while exclusions include reversible causes of poor intake and current tube or parenteral feeding. Study sites are operated by NGM Biopharmaceuticals and are located in California, requiring in-person visits for dosing and monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults with active colorectal cancer who meet the Fearon criteria for cachexia, can give informed consent, and are not receiving tube feedings or parenteral nutrition.
Not a fit: Patients with reversible causes of poor food intake, those on tube feedings or parenteral nutrition, or those whose cachexia is due to other non-cancer causes are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, NGM120 could help patients with colorectal cancer-related cachexia preserve or regain weight and improve physical function and quality of life.
How similar studies have performed: Previous pharmacologic approaches to cancer cachexia have shown limited but sometimes encouraging results, and NGM120 represents a relatively novel candidate being tested in this space.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 27 other locations
- NGM Clinical Study Site — Los Angeles, California, United States (Recruiting)
- NGM Clinical Study Site — Los Angeles, California, United States (Recruiting)
- NGM Clinical Study Site — Santa Rosa, California, United States (Recruiting)
- NGM Clinical Study Site — Margate, Florida, United States (Recruiting)
- NGM Clinical Study Site — Baltimore, Maryland, United States (Recruiting)
- NGM Clinical Study Site — New York, New York, United States (Recruiting)
- NGM Clinical Study Site — Toledo, Ohio, United States (Recruiting)
- NGM Clinical Study Site — Youngstown, Ohio, United States (Recruiting)
- NGM Clinical Study Site — Dallas, Texas, United States (Recruiting)
- NGM Clinical Study Site — Kingwood, Texas, United States (Withdrawn)
- NGM Clinical Study Site — Laredo, Texas, United States (Recruiting)
- NGM Clinical Study Site — Richmond, Virginia, United States (Recruiting)
- NGM Clinical Study Site — Appleton, Wisconsin, United States (Recruiting)
- NGM Clinical Study Site — Tbilisi, Georgia (Recruiting)
- NGM Clinical Study Site — Tbilisi, Georgia (Recruiting)
- NGM Clinical Study Site — Tbilisi, Georgia (Recruiting)
- NGM Clinical Study Site — Tbilisi, Georgia (Recruiting)
- NGM Clinical Study Site — Tbilisi, Georgia (Recruiting)
- NGM Clinical Study Site — Goyang, South Korea (Recruiting)
- NGM Clinical Study Site — Goyang, South Korea (Recruiting)
- NGM Clinical Study Site — Incheon, South Korea (Recruiting)
- NGM Clinical Study Site — Seoul, South Korea (Recruiting)
- NGM Clinical Study Site — Seoul, South Korea (Recruiting)
- NGM Clinical Study Site — Seoul, South Korea (Recruiting)
- NGM Clinical Study Site — Suwon, South Korea (Recruiting)
- NGM Clinical Study Site — Taichung, Taiwan (Recruiting)
- NGM Clinical Study Site — Taipei, Taiwan (Recruiting)
- NGM Clinical Study Site — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: NGM Study Director
- Email: NGM120CX@ngmbio.com
- Phone: 650-727-8800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.