In short
Clinical trials are investigating HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE in people with colorectal cancer and cancer cachexia. These studies aim to assess effects on body weight, safety, and tolerability. The trial data describe a randomized, double-blind, placebo-controlled Phase 2 study.
Key points
- Clinical trial data for HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE describe a Phase 2 study in people with colorectal cancer and cancer cachexia. The study is randomized, double-blind, and placebo-controlled, which helps compare the treatment fairly. It plans to enroll 136 participants. The main outcomes are change in body weight at Week 12 and treatment-emergent adverse events. The trial is focused on both possible benefit and safety.
Trial overview
The available trial data show one study of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE in people with colorectal cancer with cancer cachexia. The study is designed to compare the treatment with a placebo, which helps researchers see whether any changes are likely due to the study drug rather than chance.
Study design and phase
This is an interventional study, meaning researchers give a study treatment and then measure results. It is a Phase 2 trial, which usually looks at early signs of benefit while also continuing safety checks.
The study is randomized, double-blind, and placebo-controlled. Randomized means participants are assigned by chance, double-blind means neither the participants nor the study team knows who gets which treatment, and placebo-controlled means one group receives an inactive comparison treatment.
Who can participate
The trial is for participants with colorectal cancer who also have cancer cachexia. Cancer cachexia is a condition linked to cancer-related weight loss and muscle loss, so the study population is focused on people with this specific problem.
The planned enrollment is 136 participants. This number gives a sense of the study size, although the source data do not provide more detailed inclusion or exclusion rules.
What is being measured
The main outcome is change from baseline in body weight at Week 12. Baseline means the starting point before treatment begins, so researchers will compare weight later with the starting weight.
The study also measures treatment-emergent adverse events, or health problems that appear during the study after treatment starts. These events are described by type, frequency, severity, timing, seriousness, and whether they seem related to the study drug.
The brief summary says Part A evaluates the effect of NGM120 compared with placebo on body weight, and Part B evaluates safety and tolerability. The source data use the name NGM120 for the intervention in this study.
Trial status and size
The trial status is listed as Authorised. This means the study has been approved to proceed in the source record, but the data provided do not show study results.
The trial plans to enroll 136 people, which makes it a moderate-sized Phase 2 study. The source information includes one trial record, so the current overview is based on that single study only.
Patient-friendly terms
- Body weight change means the study checks whether participants gain, lose, or keep weight over time.
- Safety means whether unwanted health problems happen during the study.
- Tolerability means how well people can handle the treatment in daily life without major difficulties.
- Placebo means a look-alike treatment used for comparison, but it does not contain the active study drug.