NGM120 treatment for cachexia in colorectal cancer
Official title: 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
Run by NGM Biopharmaceuticals, Inc · NCT07033026 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | NGM Biopharmaceuticals, Inc Industry-sponsored |
| Locations | 28 sites (Los Angeles, California and 27 other locations) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | April 2027 |
| Study ends | December 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT07033026 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Show 22 more locations
-
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
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 -
NGM Clinical Study Site
Kingwood, Texas, United States Withdrawn
Study contacts
- Study coordinator: NGM Study Director
- Email: NGM120CX@ngmbio.com
- Phone: 650-727-8800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Examining muscle characteristics in colorectal cancer patients with cachexia
This study looks at the muscles of colorectal cancer patients with and without cachexia to see how they differ from healthy people.
-
Knife-assisted full-thickness resection for rectal lesions in a multicenter setting
A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.
-
Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model
This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery
Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.
-
Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.