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NCT07033026 | RECRUITING | Colorectal Cancer


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

NGM Biopharmaceuticals, Inc

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.

Condition or disease

Colorectal Cancer

CRC (Colorectal Cancer)

Cancer Cachexia

Intervention/treatment

NGM120 Q4W

NGM120 Q8W

Placebo given

Phase

PHASE2

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 136 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT07033026


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Locations


RECRUITING

United States, Texas

NGM Clinical Study Site

Laredo, Texas, United States, 78041

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