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

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: NGM Biopharmaceuticals, Inc (industry)

Phase: 2

Start date: June 24, 2025

Planned enrollment: 136

Trial ID: NCT07033026
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

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TrialFetch AI Analysis

Goal: Assess whether NGM120 improves body weight in people with colorectal cancer and cancer cachexia, and evaluate its safety and tolerability.

Patients: Adults with active colorectal cancer and weight loss meeting Fearon criteria for cachexia. People with a reversible cause of reduced food intake, tube feeding or parenteral nutrition, or cachexia from another cause are excluded.

Design: Multicenter, randomized, double-blind, placebo-controlled phase 2 trial with five treatment groups.

Treatments: Participants receive subcutaneous low-dose NGM120 every 4 weeks, high-dose NGM120 every 4 or 8 weeks, or placebo every 4 weeks. NGM120 is an investigational antibody that blocks GFRAL, the receptor for GDF15, to interrupt signaling implicated in appetite suppression and weight loss. In a small, uncontrolled pancreatic cancer cohort receiving chemotherapy, some patients maintained or gained weight and lean body mass, but those findings cannot establish a benefit from NGM120. This colorectal cancer trial has not reported results.

Outcomes: Primary measures are change in body weight from baseline to week 12 and treatment-emergent adverse events through 44 weeks, including their frequency, severity, timing, seriousness, and relationship to treatment.

Burden on patient: Estimated moderate burden: subcutaneous treatment requires visits every 4 or 8 weeks, with weight assessments and safety follow-up extending up to 44 weeks. No mandatory biopsies or intensive pharmacokinetic blood sampling are specified, so the main additional demands appear to be treatment visits and monitoring.

Last updated: Sep 2026

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Sites (28)

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NGM Clinical Study Site

Tbilisi, 159, Georgia

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Tbilisi, 186, Georgia

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Tbilisi, 159, Georgia

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Tbilisi, 159, Georgia

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Tbilisi, 159, Georgia

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Incheon, 21565, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Goyang, 1048, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Goyang, 10326, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Suwon, 16247, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Seoul, 6351, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Seoul, 3080, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Seoul, 2841, South Korea

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Taoyuan District, 333423, Taiwan

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Taichung, 407216, Taiwan

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Taipei, 100225, Taiwan

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Santa Rosa, California, 95403, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Los Angeles, California, 90095, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Los Angeles, California, 90033, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Margate, Florida, 33063, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Baltimore, Maryland, 21201, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

New York, New York, 10065, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Toledo, Ohio, 43608, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Youngstown, Ohio, 44504, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Laredo, Texas, 78041, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Dallas, Texas, 75390, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Richmond, Virginia, 23114, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Appleton, Wisconsin, 54915, United States

[email protected] / No phone

Status: Recruiting

NGM Clinical Study Site

Kingwood, Texas, 77339, United States

No email / No phone

Status: Withdrawn

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