Effect of anti-obesity agent HSG4112 on overweight and obese patients following 12 weeks of oral treatment: a study protocol for a randomised, double-blind, placebo-controlled, parallel-group, phase 2a clinical trial

Author:

Min Kyungha,Oh Bumjo,Koo Hye Yeon,Kim Yang-Hyun,Lee Ji-Won,Lee Sangsub,Kim Youngah,Kwon Hyuktae

Abstract

Background: Glaceum Inc. has proposed HSG4112, a structural analogue of glabridin, as a novel anti-obesity compound. Animal studies and phase I human trials have shown that HSG4112 improves energy consumption, normalises weight, and is safe and drug-resistant. Based on these results, the company plans to conduct a phase 2a clinical trial to determine the safety and efficacy of HSG4112 in overweight and obese patients. Methods: A 16-week randomised, double-blind, placebo-controlled, parallel-group trial will be conducted at five large hospitals in South Korea to assess the safety and efficacy of HSG4112 in overweight and obese patients. Participants who meet the inclusion/exclusion criteria will be assigned a subject number and randomly assigned to one of the four treatment groups (one group receiving a placebo) in a 1:1:1:1 ratio. The study’s primary outcome will be to monitor the change in body weight (kg) from baseline to the end of treatment while monitoring safety and tolerability. Discussion: This trial will evaluate the efficacy and safety of HSG4112 in overweight and obese adults. Upon proving the safety and effectiveness of the newly developed mechanism, it might significantly improve the perception of the product among medical personnel and obese patients. Furthermore, it may aid in managing chronic conditions that require long-term treatment.Trial registration:ClinicalTrials.gov, identifier [NCT05197556].

Publisher

Frontiers Media SA

Subject

Pharmacology (medical),Pharmacology

Reference14 articles.

1. The effectiveness of the low energy diet in overweight and obese adults;Całyniuk;Rocz. Panstw Zakl. Hig.,2016

2. Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity;Choi;Int. J. Obes.,2021

3. Burden of elevated body mass index and its association with non-communicable diseases in patients presenting to an endocrinology clinic;Ghaus;Cureus,2021

4. Latest approaches for the treatment of obesity;Jackson;Expert Opin. Drug Discov.,2015

5. Diseases and disorders associated with excess body weight;Knight;Ann. Clin. Lab. Sci.,2011

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