An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.

NCT07033026 · tracked via the Priya Life Science USA tracker

Sponsor

NGM Biopharmaceuticals, Inc

Phase

Phase 2

Started

2025-06-25

Last updated

2026-04-01

Condition(s) studied

Colorectal CancerCRC (Colorectal Cancer)Cancer Cachexia

Investigational drug(s) / intervention(s)

NGM120 Q4WNGM120 Q8WPlacebo given

NGM120 Q4W: NGM120 given subcutaneously every 4 weeks

NGM120 Q8W: NGM120 given subcutaneously every 8 weeks

Placebo given: Placebo given subcutaneously every 4 weeks

Study summary

A multi-center evaluation of NGM120 in a randomized, double-blind, placebo-controlled study in participants with colorectal cancer who have cancer cachexia.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline in body weight at Week 12 — 12 Weeks
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 — 44 Weeks
To evaluate safety and tolerability of NGM120

Trial sites (28)

Facility	City	Region	Status
NGM Clinical Study Site	Los Angeles	California	Recruiting
NGM Clinical Study Site	Los Angeles	California	Recruiting
NGM Clinical Study Site	Santa Rosa	California	Recruiting
NGM Clinical Study Site	Margate	Florida	Recruiting
NGM Clinical Study Site	Baltimore	Maryland	Recruiting
NGM Clinical Study Site	New York	New York	Recruiting
NGM Clinical Study Site	Toledo	Ohio	Recruiting
NGM Clinical Study Site	Youngstown	Ohio	Recruiting
NGM Clinical Study Site	Dallas	Texas	Recruiting
NGM Clinical Study Site	Kingwood	Texas	Withdrawn
NGM Clinical Study Site	Laredo	Texas	Recruiting
NGM Clinical Study Site	Richmond	Virginia	Recruiting
NGM Clinical Study Site	Appleton	Wisconsin	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07033026 on ClinicalTrials.gov ↗ ← All trials in the USA