BI 3006337 / Yuhan Corp - LARVOL DELTA

Boehringer Ingelheim terminates steatohepatitis drug development, returns rights to Yuhan (Korea Biomedical Review) - "Yuhan Corp. said that Boehringer Ingelheim has decided to discontinue the development of BI 3006337, a GLP-1/FGF21 dual agonist (YH25724), and return all rights to the company....BI 3006337 was being developed as a treatment for metabolic dysfunction-associated steatohepatitis (MASH) and related liver diseases....Despite Boehringer Ingelheim’s decision to return the rights, Yuhan remains committed to the continued development of BI 3006337, the company said....'The upfront payment of $40 million and milestone payment of $10 million that we received from Boehringer Ingelheim are non-refundable,'..."

Licensing / partnership • Metabolic Dysfunction-Associated Steatohepatitis

A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion

A novel GLP-1/FGF21 dual agonist ZT003 has therapeutic potential for obesity, MASH and SHTG (EASD 2024) - "When tested in DIO obese mice and db/db diabetic obesity mice, ZT003 demonstrated synergistic, sustained, and superior body weight reduction and glucose-lowering effect versus semaglutide, tirzepatide and YH25724... In conclusion, this novel GLP-1/FGF21 fusion protein in animals reveals therapeutically efficacious to treat obesity, MASH and SHTG, thus demonstrating the promise of the poly-pharmaceutical approach in metabolic drug discovery and development."

Late-breaking abstract • Diabetes • Hypertriglyceridemia • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Type 2 Diabetes Mellitus • FGF21 • KLB

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease (clinicaltrials.gov) - P1 | N=63 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Novel GLP-1/FGF21 Dual Agonist ZT003 Has Therapeutic Potential for Obesity, Diabetes, and Nonalcoholic Steatohepatitis (ADA 2024) - "When tested in DIO obese mice and db/db diabetic mice, ZT003 demonstrated synergistic, sustained, and superior body weight reduction and glucose-lowering effect versus semaglutide, tirzepatide and YH25724... In Conclusion, this novel GLP-1/FGF21 fusion protein in animals reveals therapeutically efficacious to treat obesity, diabetes, NASH and related co-morbidities, thus demonstrating the promise of the poly-pharmaceutical approach in metabolic drug discovery and development."

Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • FGF21 • KLB

Yuhan Corporation technology transfer MASH/obesity drug candidate begins clinical trials targeting Japanese men [Google translation] (News1 Korea) - "'According to the industry on the 2nd, Boehringer Ingelheim began a phase 1 clinical trial last month to investigate the safety, tolerability, and pharmacokinetics of YH25724 in healthy male Japanese subjects. The target recruitment process is currently in progress. YH25724 Japanese phase 1 clinical trial is recruiting 36 subjects. Nine people are divided into four groups and each receives YH25724 from low to high doses. The primary evaluation indicator is the proportion of subjects who experience adverse reactions that are judged to be drug-related. The study will be conducted at the Tokyo Clinical Hospital in Japan."

Trial status • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Japanese Men to Test How Will Different Doses of BI 3006337 Are Tolerated (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial

Boehringer Ingelheim succeeds in phase 2 obesity/MASH new drug… Symptoms improved in 83% of the medication group [Google translation] (News1 Korea) - "In addition to BI456906, Boehringer Ingelheim is also conducting phase 1b of 'YH25724', a new drug candidate for obesity and MASH introduced by Yuhan Corporation....Boehringer Ingelheim expanded the YH25724 clinical site and accelerated the target research completion date. The target research completion date, which was originally January 23, 2025, was shortened to December 10, 2024."

Trial completion date • Trial status • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Phase 1 clinical trial of new drug for NASH and obesity with technology transferred from Yuhan Corporation [Google translation] (Financial News) - "Phase 1b clinical trials for 'YH25724', a new drug candidate for non-alcoholic steatohepatitis (NASH) and obesity, transferred by Yuhan Corporation to global pharmaceutical company Boehringer Ingelheim, have accelerated. Boehringer Ingelheim expanded the number of clinical trial sites in the U.S. and accelerated the target research completion date....Patient recruitment is underway in three locations in California, three in Florida, one in Ohio, and one in Texas."

Enrollment status • Trial status • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity

Yuhan Corp. Technology Transfer NASH New Drug Candidate Initiated Phase 1 Obesity Indication [Google translation] (News1 Korea) - "Yuhan Corporation...has started clinical trials for non-alcoholic steatohepatitis (NASH) new drug candidate 'YH25724' for obesity indications....Boehringer Ingelheim started recruiting patients for phase 1b clinical trials of YH25724 on the 15th....This clinical trial is conducted on 56 patients with overweight, obesity, or non-alcoholic fatty liver disease (NAFLD). Males or females between the ages of 18 and 75 are recruited....The target study completion date for this clinical trial is January 23, 2025."

Trial completion date • Trial status • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity

A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Obesity

A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Obesity

YH25724, a novel long-acting GLP-1/FGF21 dual agonist, exhibits marked anti-fibrotic effects in different experimental models of liver fibrosis (EASL-ILC 2019) - No abstract available.

YH25724, a novel long-acting GLP-1/FGF21 dual agonist, exhibits marked anti-fibrotic effects in different experimental models of liver fibrosis (EASL-ILC 2019) - "YH25724 markedly attenuated the progression of fibrosis in rat models. These data support the general anti-fibrotic potential of this hybrid molecule, which occurs independent of body weight reduction. YH25724 may therefore provide not only metabolic but also strong anti-fibrotic benefits in patients with NASH."