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
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 pla...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-08-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1177539/full |
| _version_ | 1827860972810797056 |
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| author | Kyungha Min Bumjo Oh Hye Yeon Koo Yang-Hyun Kim Ji-Won Lee Ji-Won Lee Sangsub Lee Youngah Kim Hyuktae Kwon |
| author_facet | Kyungha Min Bumjo Oh Hye Yeon Koo Yang-Hyun Kim Ji-Won Lee Ji-Won Lee Sangsub Lee Youngah Kim Hyuktae Kwon |
| author_sort | Kyungha Min |
| collection | DOAJ |
| description | 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]. |
| first_indexed | 2024-03-12T13:30:34Z |
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| id | doaj.art-88d4e45a96b844b19819f5ef6b404e96 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-12T13:30:34Z |
| publishDate | 2023-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-88d4e45a96b844b19819f5ef6b404e962023-08-24T13:55:55ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-08-011410.3389/fphar.2023.11775391177539Effect 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 trialKyungha Min0Bumjo Oh1Hye Yeon Koo2Yang-Hyun Kim3Ji-Won Lee4Ji-Won Lee5Sangsub Lee6Youngah Kim7Hyuktae Kwon8Department of Family Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of KoreaDepartment of Family Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Centre, Seoul, Republic of KoreaDepartment of Family Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of KoreaDepartment of Family Medicine, Korea University College of Medicine, Seoul, Republic of KoreaDepartment of Family Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of KoreaInstitute for Innovation in Digital Healthcare, Yonsei University, Seoul, Republic of KoreaGlaceum Incorporated, Suwon, Republic of KoreaGlaceum Incorporated, Suwon, Republic of KoreaDepartment of Family Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, Republic of KoreaBackground: 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].https://www.frontiersin.org/articles/10.3389/fphar.2023.1177539/fullobesityoverweightweight lossobesity drugrandomised controlled trial |
| spellingShingle | Kyungha Min Bumjo Oh Hye Yeon Koo Yang-Hyun Kim Ji-Won Lee Ji-Won Lee Sangsub Lee Youngah Kim Hyuktae Kwon 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 Frontiers in Pharmacology obesity overweight weight loss obesity drug randomised controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | obesity overweight weight loss obesity drug randomised controlled trial |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1177539/full |
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