Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07033026

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

Led by NGM Biopharmaceuticals, Inc · Updated on 2026-04-01

136

Participants Needed

28

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of NGM120 in people with colorectal cancer who also have cancer cachexia, a condition involving significant weight loss. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess the safety, tolerability, and potential benefits of NGM120 in this population. Participants will receive either NGM120 or a placebo through subcutaneous injections. NGM120 is given in different dosing schedules: low dose every 4 weeks, high dose every 4 weeks, or high dose every 8 weeks. Placebo is administered every 4 weeks. These treatments will be compared to evaluate differences. Throughout the study, participants' body weight changes will be monitored for 12 weeks to assess treatment impact. Safety will be evaluated by tracking adverse events over 44 weeks. Participants will undergo regular assessments, including monitoring for treatment effects and side effects, with the total study duration extending up to 44 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented active diagnosis of colorectal cancer
  • Cachexia defined by Fearon criteria of weight loss
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Current active reversible causes of decreased food intake
  • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
  • Cachexia caused by other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants receive NGM120 or placebo given subcutaneously at intervals of every 4 or 8 weeks depending on the treatment group.

Visits every 4 or 8 weeks during treatment

Trial Site Locations

Total: 28 locations

1

NGM Clinical Study Site

Los Angeles, California, United States, 90033

Actively Recruiting

2

NGM Clinical Study Site

Los Angeles, California, United States, 90095

Actively Recruiting

3

NGM Clinical Study Site

Santa Rosa, California, United States, 95403

Actively Recruiting

4

NGM Clinical Study Site

Margate, Florida, United States, 33063

Actively Recruiting

5

NGM Clinical Study Site

Baltimore, Maryland, United States, 21201

Actively Recruiting

6

NGM Clinical Study Site

New York, New York, United States, 10065

Actively Recruiting

7

NGM Clinical Study Site

Toledo, Ohio, United States, 43608

Actively Recruiting

8

NGM Clinical Study Site

Youngstown, Ohio, United States, 44504

Actively Recruiting

9

NGM Clinical Study Site

Dallas, Texas, United States, 75390

Actively Recruiting

10

NGM Clinical Study Site

Kingwood, Texas, United States, 77339

Withdrawn

11

NGM Clinical Study Site

Laredo, Texas, United States, 78041

Actively Recruiting

12

NGM Clinical Study Site

Richmond, Virginia, United States, 23114

Actively Recruiting

13

NGM Clinical Study Site

Appleton, Wisconsin, United States, 54915

Actively Recruiting

14

NGM Clinical Study Site

Tbilisi, Georgia, 159

Actively Recruiting

15

NGM Clinical Study Site

Tbilisi, Georgia, 159

Actively Recruiting

16

NGM Clinical Study Site

Tbilisi, Georgia, 159

Actively Recruiting

17

NGM Clinical Study Site

Tbilisi, Georgia, 159

Actively Recruiting

18

NGM Clinical Study Site

Tbilisi, Georgia, 186

Actively Recruiting

19

NGM Clinical Study Site

Goyang, South Korea, 10326

Actively Recruiting

20

NGM Clinical Study Site

Goyang, South Korea, 1048

Actively Recruiting

21

NGM Clinical Study Site

Incheon, South Korea, 21565

Actively Recruiting

22

NGM Clinical Study Site

Seoul, South Korea, 2841

Actively Recruiting

23

NGM Clinical Study Site

Seoul, South Korea, 3080

Actively Recruiting

24

NGM Clinical Study Site

Seoul, South Korea, 6351

Actively Recruiting

25

NGM Clinical Study Site

Suwon, South Korea, 16247

Actively Recruiting

26

NGM Clinical Study Site

Taichung, Taiwan, 407216

Actively Recruiting

27

NGM Clinical Study Site

Taipei, Taiwan, 100225

Actively Recruiting

28

NGM Clinical Study Site

Taoyuan, Taiwan, 333423

Actively Recruiting

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Research Team

N

NGM Study Director

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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