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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07033026

Enrollment

136

Registered

2025-06-24

Start date

2025-06-25

Completion date

2027-12-01

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cachexia, Colorectal Cancer, CRC (Colorectal Cancer)

Keywords

Cancer Cachexia, Colorectal Cancer, CRC

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.

Detailed description

Evaluation of Efficacy, Safety and Tolerability of NGM120 in a Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Participants with Colorectal Cancer who have Cancer Cachexia

Interventions

DRUGNGM120 Q4W

NGM120 given subcutaneously every 4 weeks

DRUGNGM120 Q8W

NGM120 given subcutaneously every 8 weeks

DRUGPlacebo given

Placebo given subcutaneously every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Georgia, South Korea, Taiwan, United States

Contacts

CONTACTNGM Study Director

NGM120CX@ngmbio.com650-727-8800

STUDY_DIRECTORNGM Study Director

NGM Biopharmaceuticals, Inc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026