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

NCT ID: NCT07033026

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-12-31

Brief Summary

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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

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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

Conditions

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Colorectal Cancer CRC (Colorectal Cancer) Cancer Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NGM120 Treatment Group A

NGM120 low dose given subcutaneously every 4 weeks

Group Type EXPERIMENTAL

NGM120 Q4W

Intervention Type DRUG

NGM120 given subcutaneously every 4 weeks

NGM120 Treatment Group B

Placebo low dose given subcutaneously every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo given

Intervention Type DRUG

Placebo given subcutaneously every 4 weeks

NGM120 Treatment Group C

NGM120 high dose given subcutaneously every 4 weeks

Group Type EXPERIMENTAL

NGM120 Q4W

Intervention Type DRUG

NGM120 given subcutaneously every 4 weeks

NGM120 Treatment Group D

NGM120 high dose given subcutaneously every 8 weeks

Group Type EXPERIMENTAL

NGM120 Q8W

Intervention Type DRUG

NGM120 given subcutaneously every 8 weeks

NGM120 Treatment Group E

Placebo high dose given subcutaneously every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo given

Intervention Type DRUG

Placebo given subcutaneously every 4 weeks

Interventions

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NGM120 Q4W

NGM120 given subcutaneously every 4 weeks

Intervention Type DRUG

NGM120 Q8W

NGM120 given subcutaneously every 8 weeks

Intervention Type DRUG

Placebo given

Placebo given subcutaneously every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NGM Biopharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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NGM Study Director

Role: STUDY_DIRECTOR

NGM Biopharmaceuticals, Inc

Locations

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NGM Clinical Study Site

Laredo, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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NGM Study Director

Role: CONTACT

650-243-5555

Facility Contacts

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NGM Site 101

Role: primary

Other Identifiers

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120-CX-202

Identifier Type: -

Identifier Source: org_study_id

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