Case Study

Overcoming Known Pharmacological Effects

Source: Altasciences
Pharmaceutical Tablets GettyImages-610221624

Altasciences was contracted to conduct an IND-enabling study in dogs, involving once-daily oral administration of a GLP-1 receptor agonist. These molecules are known to reduce gastric emptying and increase feelings of satiety, while also inhibiting glucagon release from pancreatic alpha cells, which decreases sugar production and release from the liver. As a result, the common pharmacological effects observed in these studies include reduced food consumption and body weight loss.

While these effects are expected, they pose a challenge as we assess the test article for potential toxicological impacts. The design of the molecule itself induces these changes, so it is crucial to carefully monitor the animals' health to differentiate between intended effects and potential toxicity. Maintaining the well-being of the animals throughout the 28-day study was also essential to ensuring the successful completion of the IND-enabling study.

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