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Trial completion date, Trial primary completion date: Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects (clinicaltrials.gov) - Feb 19, 2025 P2, N=240, Recruiting, The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025). Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: May 2025 --> May 2026
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Clinical, P2 data, Journal, Biopsy: A phase 2, adaptive randomized, double-blind, placebo-controlled, multicenter, 52-week study of HM15211 in patients with biopsy-confirmed non-alcoholic steatohepatitis - Study design and rationale of HM-TRIA-201 study. (Pubmed Central) - Jun 14, 2023 An interim analysis is planned after 15 patients/group complete 26?weeks of treatment, after which one HM15211 dose group will be discontinued based on safety and efficacy risk-to-benefit analysis; patients of the dropped dosing arm will be re-randomized into 2 remaining HM15211 groups. The adaptive design study of HM15211 minimizes the number of patients to be exposed to a liver biopsy while optimizing the sample size of patients exposed to safe and effective doses of HM15211 to inform ideal dose for further clinical development in NASH.
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Antifibrotic Potential of a Novel Long-Acting Glucagon/GIP/GLP-1 Triple Agonist (HM15211) in Preclinical Models of IPF (Poster Hall (Halls D-E); Board No. 754) - May 11, 2022 - Abstract #ADA2022ADA_1468; Notably, HM15211 (61%) showed more improved survival rate than NINT (33%), and PIRF (28%), suggesting potential superiority of HM15211 over current IPF drugs.In conclusion, HM15211 may be a novel therapeutic potential for pulmonary fibrosis over current standard of care for IPF. Further evidences from the mechanistic studies will shed light on a direct inhibitory effect of HM15211 on pulmonary fibrosis.
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There is a strong interest in developing obesity treatments based on glucagon-like peptide-1 (GLP-1) agonism, which have proved to limit morbidity and mortality in type 2 diabetes.Areas covered: This review provides an overview of current compounds containing GLP-1 receptor agonism in clinical development for obesity, with mono-activity at the GLP-1 receptor (PF-0688296, glutazumab, semaglutide) or engaging one or more other endogenous hormonal systems involved in energy balance and metabolism, including glucagon, oxyntomodulin, glucose-dependent inhibitory peptide and amylin (CT-868, CT-388, AMG 133, tirzepatide, NNC9204-1177, JNJ-54728518, SAR425899, pegapamodutide, MK8521, cotadutide, efinopegdutide, BI-456906, cagrilintide + semaglutide 2,4 mg, HM15211, NNC9204-1706).Expert opinion: Many novel compounds employing GLP-1 receptor agonism are in clinical development. Semaglutide is farthest in clinical development and will presumably become a benchmark for this class of novel anti-obesity compounds.
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Enrollment change, Trial completion date, Trial primary completion date: Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects (clinicaltrials.gov) - Jan 11, 2022 P2, N=217, Recruiting, Semaglutide is farthest in clinical development and will presumably become a benchmark for this class of novel anti-obesity compounds. N=112 --> 217 | Trial completion date: Dec 2022 --> Nov 2024 | Trial primary completion date: Mar 2022 --> Sep 2022
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Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD (clinicaltrials.gov) - Aug 10, 2020 P1, N=66, Completed, Further studies are needed to assess the clinical relevance of these findings. Recruiting --> Completed | N=48 --> 66 | Trial completion date: Sep 2019 --> Mar 2020 | Trial primary completion date: Jun 2019 --> Mar 2020
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