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

NGM Biopharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: CRC (Colorectal Cancer); Cancer Cachexia; Colorectal Cancer

Treatments: Drug: NGM120 Q8W; Drug: NGM120 Q4W; Drug: Placebo given

Study type: Interventional

Funder types: Industry

Identifiers

NCT07033026

120-CX-202

Details and patient eligibility

About

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

Full 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

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 5 patient groups, including a placebo group

NGM120 Treatment Group A

Experimental group

Description:

NGM120 low dose given subcutaneously every 4 weeks

Treatment:

Drug: NGM120 Q4W

NGM120 Treatment Group B

Placebo Comparator group

Description:

Placebo low dose given subcutaneously every 4 weeks

Treatment:

Drug: Placebo given

NGM120 Treatment Group C

Experimental group

Description:

NGM120 high dose given subcutaneously every 4 weeks

Treatment:

Drug: NGM120 Q4W

NGM120 Treatment Group D

Experimental group

Description:

NGM120 high dose given subcutaneously every 8 weeks

Treatment:

Drug: NGM120 Q8W

NGM120 Treatment Group E

Placebo Comparator group

Description:

Placebo high dose given subcutaneously every 4 weeks

Treatment:

Drug: Placebo given