A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
1. Study Objective
- To assess the effect of HSG4112 on body weight
- To evaluate the safety and tolerability of HSG4112
2. 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.
3. 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.
4. 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.
Phase:
Phase 2
Details
Lead Sponsor:
Glaceum
Collaborators:
Gangnam Severance Hospital Korea University Anam Hospital Seoul National University Bundang Hospital Seoul National University Hospital SMG-SNU Boramae Medical Center