Recruiting

Phase 2

NGM120An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.

Sponsor:

NGM Biopharmaceuticals, Inc

Code:

NCT07033026

Conditions

Colorectal Cancer

CRC (Colorectal Cancer)

Cancer Cachexia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NGM120 Q4W

NGM120 Q8W

Placebo given

Study Details

Brief summary:

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

Conditions

Colorectal Cancer

CRC (Colorectal Cancer)

Cancer Cachexia

Study ID

NCT07033026

Start date

Jun 25, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NGM120 Treatment Group A

NGM120 low dose given subcutaneously every 4 weeks

placebo comparator: NGM120 Treatment Group B

Placebo low dose given subcutaneously every 4 weeks

experimental: NGM120 Treatment Group C

NGM120 high dose given subcutaneously every 4 weeks

experimental: NGM120 Treatment Group D

NGM120 high dose given subcutaneously every 8 weeks

placebo comparator: NGM120 Treatment Group E

Placebo high dose given subcutaneously every 4 weeks

Interventions

NGM120 Q4W

NGM120 given subcutaneously every 4 weeks

NGM120 Q8W

NGM120 given subcutaneously every 8 weeks

Placebo given

Placebo given subcutaneously every 4 weeks

Primary outcome measure

Change from baseline in body weight at Week 12 [ Time Frame: 12 Weeks ]
Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug [ Time Frame: 44 Weeks ]

Central Contacts and Locations

Central contacts

NGM Study Director

650-727-8800 NGM120CX@ngmbio.com

Locations

NGM Clinical Study Site

Recruiting

Los Angeles, California, United States, 90033

Contacts

NGM Site 115

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Los Angeles, California, United States, 90095

Contacts

NGM Site 105

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Santa Rosa, California, United States, 95403

Contacts

NGM Site 103

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Margate, Florida, United States, 33063

Contacts

NGM Site 106

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

NGM Site 104

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

New York, New York, United States, 10065

Contacts

NGM Site 113

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Toledo, Ohio, United States, 43608

Contacts

NGM Site 109

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Youngstown, Ohio, United States, 44504

Contacts

NGM Site 111

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Dallas, Texas, United States, 75390

Contacts

NGM Site 102

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Laredo, Texas, United States, 78041

Contacts

NGM Site 101

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Richmond, Virginia, United States, 23114

Contacts

NGM Site 114

NGM120CX@ngmbio.com

NGM Clinical Study Site

Recruiting

Appleton, Wisconsin, United States, 54915

Contacts

NGM Site 112

NGM120CX@ngmbio.com

More Information

Sponsor

NGM Biopharmaceuticals, Inc

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

Cancer Cachexia
Colorectal Cancer
CRC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NGM Biopharmaceuticals, Inc on 2026-04-01.