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Phase 1 trials for two novel treatments of obesity and/or diabetes initiated by Zealand partner Boehringer Ingelheim

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Zealand Pharma A/S ("Zealand") reports that Boehringer Ingelheim has announced the initiation of two Phase 1 trials, the first with a glucagon/GLP-1 agonist that has the potential for once-weekly administration for the treatment of obesity and/or type 2 diabetes and the second with a novel differentiated long-acting amylin analog for the treatment of obesity and/or diabetes.

GLP-1/glucagon dual-acting agonist
The dual-acting glucagon/GLP-1 agonist activates both the GLP-1 and glucagon receptors, two key gut hormone receptors and may offer better blood sugar and weight loss control than currently available single agonist treatments. The compound builds partly on the effects of the natural gut hormone oxyntomodulin, which has been shown to decrease food intake and increase energy expenditure in humans.

The clinical development of this dual glucagon/GLP-1 agonist will start with a randomized, double-blind, first-in-human study to evaluate the safety and tolerability of single ascending doses in healthy subjects. The study will be conducted in Germany (EudraCT Number: 2017-000295-29; ClinicalTrials.gov Identifier: NCT03175211). Results are expected in late 2018.

 

Long-acting amylin analog
Amylin is a pancreatic peptide hormone that plays an important role in decreasing food intake and in the regulation of postprandial plasma glucose levels. The compound is a long-acting analog of amylin and it has demonstrated significant weight loss in preclinical models of obesity.

The Phase 1 trial is a randomized, double-blind, first-in-human study to evaluate the safety and tolerability of single ascending doses in healthy subjects. The study will be conducted in Germany (EudraCT Number: 2016-003224-24; ClinicalTrials.gov Identifier: NCT03195088) and funded by Boehringer Ingelheim, with results expected in late 2018.

The global prevalence of obesity has more than doubled since 1980. In 2014, more than 1.9 billion adults were classified as overweight and over 600 million of these were obese.

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