Glaceum

Study Objective
To assess the effect of HSG4112 on body weight
To evaluate the safety and tolerability of HSG4112
Background
Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of HSG4112 in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the safety and efficacy of HSG4112 in overweight and obese patients.
Number of Subjects
This study is a Phase 2a clinical trial designed to evaluate the safety and efficacy of HSG4112 following multiple-dose administration. The subject sample size estimate for the primary efficacy endpoint was based on total body weight, and assumes repeated measurement of body weight occurs at Baseline and every 4 weeks thereafter during the 12-week treatment period. Based on similar weight loss studies with obesity drugs, the covariance matrix for body weight change over time is estimated as AR(1) (sigma = 3.07, rho = 0.9). Thus, with 20 subjects completing each treatment group, this study can detect a mean difference of 6 kg between HSG4112 and matching placebo treatments with 80% power, assuming a two-sided α-level of 0.05. Therefore, the target sample size for this study is 20 subjects/group.
Study Design and Protocol
This study is a randomized, double-blind, placebo-controlled, parallel-groups trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 4 treatment groups - 1 group receiving placebo - in a 1:1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 12 weeks according to the study protocol. Body weight and obesity/metabolism-related parameters will be evaluated to assess the efficacy of HSG4112. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory tests, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of HSG4112. Blood samples will be collected for pharmacokinetic assessment and samples from subjects who have signed the consent form for the exploratory genetic research will undergo analysis to detect PON2 gene polymorphism.