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

NCT07033026 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 120-CX-202
• Study Type: interventional
• Target: 136
• Locations: 4 countries
• Sites: 28

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

Keywords

Cancer Cachexia; Colorectal Cancer; CRC

Outcome Measures

Primary Outcomes (2)

• Change from baseline in body weight at Week 12

  To evaluate the effect of NGM120 compared to placebo on body weight.

  12 Weeks

• Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug

  To evaluate safety and tolerability of NGM120

  44 Weeks

Study Arms (5)

NGM120 Treatment Group A

EXPERIMENTAL

NGM120 low dose given subcutaneously every 4 weeks

Drug: NGM120 Q4W

NGM120 Treatment Group B

PLACEBO COMPARATOR

Placebo low dose given subcutaneously every 4 weeks

Drug: Placebo given

NGM120 Treatment Group C

EXPERIMENTAL

NGM120 high dose given subcutaneously every 4 weeks

Drug: NGM120 Q4W

NGM120 Treatment Group D

EXPERIMENTAL

NGM120 high dose given subcutaneously every 8 weeks

Drug: NGM120 Q8W

NGM120 Treatment Group E

PLACEBO COMPARATOR

Placebo high dose given subcutaneously every 4 weeks

Drug: Placebo given

Interventions

NGM120 Q4W DRUG

NGM120 given subcutaneously every 4 weeks

NGM120 Treatment Group A; NGM120 Treatment Group C

NGM120 Q8W DRUG

NGM120 given subcutaneously every 8 weeks

NGM120 Treatment Group D

Placebo given DRUG

Placebo given subcutaneously every 4 weeks

NGM120 Treatment Group B; NGM120 Treatment Group E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented active diagnosis of colorectal cancer.
• Cachexia defined by Fearon criteria of weight loss.
• Signed informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead

Study Sites (28)

NGM Clinical Study Site

Los Angeles, California, 90033, United States

RECRUITING

NGM Clinical Study Site

Los Angeles, California, 90095, United States

RECRUITING

NGM Clinical Study Site

Santa Rosa, California, 95403, United States

RECRUITING

NGM Clinical Study Site

Margate, Florida, 33063, United States

RECRUITING

NGM Clinical Study Site

Baltimore, Maryland, 21201, United States

RECRUITING

NGM Clinical Study Site

New York, New York, 10065, United States

RECRUITING

NGM Clinical Study Site

Toledo, Ohio, 43608, United States

RECRUITING

NGM Clinical Study Site

Youngstown, Ohio, 44504, United States

RECRUITING

NGM Clinical Study Site

Dallas, Texas, 75390, United States

RECRUITING

NGM Clinical Study Site

Kingwood, Texas, 77339, United States

WITHDRAWN

NGM Clinical Study Site

Laredo, Texas, 78041, United States

RECRUITING

NGM Clinical Study Site

Richmond, Virginia, 23114, United States

RECRUITING

NGM Clinical Study Site

Appleton, Wisconsin, 54915, United States

RECRUITING

NGM Clinical Study Site

Tbilisi, 159, Georgia

RECRUITING

NGM Clinical Study Site

Tbilisi, 159, Georgia

RECRUITING

NGM Clinical Study Site

Tbilisi, 159, Georgia

RECRUITING

NGM Clinical Study Site

Tbilisi, 159, Georgia

RECRUITING

NGM Clinical Study Site

Tbilisi, 186, Georgia

RECRUITING

NGM Clinical Study Site

Goyang, 10326, South Korea

RECRUITING

NGM Clinical Study Site

Goyang, 1048, South Korea

RECRUITING

NGM Clinical Study Site

Incheon, 21565, South Korea

RECRUITING

NGM Clinical Study Site

Seoul, 2841, South Korea

RECRUITING

NGM Clinical Study Site

Seoul, 3080, South Korea

RECRUITING

NGM Clinical Study Site

Seoul, 6351, South Korea

RECRUITING

NGM Clinical Study Site

Suwon, 16247, South Korea

RECRUITING

NGM Clinical Study Site

Taichung, 407216, Taiwan

RECRUITING

NGM Clinical Study Site

Taipei, 100225, Taiwan

RECRUITING

NGM Clinical Study Site

Taoyuan District, 333423, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• NGM Study Director

  NGM Biopharmaceuticals, Inc

  STUDY DIRECTOR

Central Study Contacts

NGM Study Director

CONTACT

650-727-8800; NGM120CX@ngmbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (13); GE (5); TW (3); KR (7)