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

Phase 2RecruitingNCT07033026

NGM Biopharmaceuticals, Inc136 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Colorectal Cancer CRC (Colorectal Cancer)Cancer Cachexia

Interventions

NGM120 Q4WDRUG

NGM120 given subcutaneously every 4 weeks

NGM120 Q8WDRUG

NGM120 given subcutaneously every 8 weeks

Placebo givenDRUG

Placebo given subcutaneously every 4 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (28)

Outcomes

Primary Outcomes

Change from baseline in body weight at Week 12

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

Time frame: 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

Time frame: 44 Weeks

Central Contacts

NGM Study Director

CONTACT

650-727-8800 NGM120CX@ngmbio.com

Data from ClinicalTrials.gov

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