An Evaluation of NGM120 in a Randomized, Double-blind, Placebo-controlled Study in Participants With Colorectal Cancer Who Have Cancer Cachexia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NGM120 Q4W, NGM120 Q8W, Placebo given.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, CRC (Colorectal Cancer), Cancer Cachexia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Georgia, South Korea, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug NGM120 Q4W
NGM120 given subcutaneously every 4 weeks - Drug NGM120 Q8W
NGM120 given subcutaneously every 8 weeks - Drug Placebo given
Placebo given subcutaneously every 4 weeks
Primary outcome measures
- Change from baseline in body weight at Week 12 [Time frame: 12 Weeks]
- Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug [Time frame: 44 Weeks]
Eligibility criteria
Inclusion criteria
- Documented active diagnosis of colorectal cancer.
- Cachexia defined by Fearon criteria of weight loss.
- Signed informed consent.
Exclusion criteria
- Current active reversible causes of decreased food intake.
- Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
- Have cachexia caused by other reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- NGM Clinical Study Site — Los Angeles
- NGM Clinical Study Site — Los Angeles
- NGM Clinical Study Site — Santa Rosa
- NGM Clinical Study Site — Margate
- NGM Clinical Study Site — Baltimore
- NGM Clinical Study Site — New York
- NGM Clinical Study Site — Toledo
- NGM Clinical Study Site — Youngstown
- … and 5 more centers
South Korea · 7 centers
- NGM Clinical Study Site — Goyang
- NGM Clinical Study Site — Goyang
- NGM Clinical Study Site — Incheon
- NGM Clinical Study Site — Seoul
- NGM Clinical Study Site — Seoul
- NGM Clinical Study Site — Seoul
- NGM Clinical Study Site — Suwon
Georgia · 5 centers
- NGM Clinical Study Site — Tbilisi
- NGM Clinical Study Site — Tbilisi
- NGM Clinical Study Site — Tbilisi
- NGM Clinical Study Site — Tbilisi
- NGM Clinical Study Site — Tbilisi
Taiwan · 3 centers
- NGM Clinical Study Site — Taichung
- NGM Clinical Study Site — Taipei
- NGM Clinical Study Site — Taoyuan
Identifiers
NCT: NCT07033026 · 120-CX-202