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
Phase 2 – studying effectiveness and dosage
Conditions:
Colorectal Cancer with Cancer Cachexia
Sponsor: Ngm Biopharmaceuticals Inc.
trial.available_in:
БГ
Overview
Trial status: Authorised
Key: Change from baseline in body weight at Week 16, Change from baseline over time in: − FAACT sub-scale scores (FAACT-ACS, FAACT-5IASS) − PROMIS (fatigue 7a & physical function 8c) − PGI-S and PGI-C (appetite and fatigue) − PGI-S and PGI-C (physical activity and walking), Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug, Change in body weight over time, Serum concentration and PK parameters of NGM120., Incidence and titer of ADA and NAb over time.
Change from baseline in body weight at Week 12, Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Description
Key: Change from baseline in body weight at Week 16, Change from baseline over time in: − FAACT sub-scale scores (FAACT-ACS, FAACT-5IASS) − PROMIS (fatigue 7a & physical function 8c) − PGI-S and PGI-C (appetite and fatigue) − PGI-S and PGI-C (physical activity and walking), Treatment-emergent adverse events (TEAEs) characterized by type, frequency, severity, timing, seriousness, and relationship to study drug, Change in body weight over time, Serum concentration and PK parameters of NGM120., Incidence and titer of ADA and NAb over time.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 54 participants