GUBamy, a Weekly Amylin Agonist, Shows Promising Weight Loss and Tolerability in Phase 1 Trial

GUBamy Development:
Gubra has initiated a Phase 1 clinical trial for GUBamy, a long-acting amylin agonist, as a potential treatment for obesity. The trial assesses safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers2.

Mechanism of Action:
Amylin, co-secreted with insulin, acts as a satiety signal, slowing gastric emptying and suppressing post-prandial glucagon responses. It enhances the satiating effect of cholecystokinin (CCK) and interacts with leptin in energy metabolism control3.

Clinical Potential:
Studies have shown that amylin analogues, such as pramlintide and cagrilintide, can lead to significant weight loss and improved glycemic control. These drugs are promising candidates for obesity treatment, especially when combined with other anti-obesity drugs14.

Combination Therapy:
Research on dual amylin and calcitonin receptor agonists (DACRAs) combined with GLP-1 analogs, like semaglutide, has shown enhanced weight loss and metabolic improvements in rat models of obesity and diabetes5.

GUBamy Trial Details:
The Phase 1 trial is a single ascending dose-escalation study in up to 48 subjects, divided into 6 cohorts, to evaluate the safety and pharmacokinetic properties of GUBamy. The trial is expected to complete enrollment by mid-20242.

Sources:

1. https://pubmed.ncbi.nlm.nih.gov/34929674/

2. https://www.gubra.dk/mfn_news/gubra-announces-first-subject-dosed-in-phase-1-clinical-trial-of-amylin-agonist-gubamy-for-the-treatment-of-obesity/

3. https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2020.617400/full

4. https://www.mdpi.com/1422-0067/25/3/1517

5. https://www.physiology.org/detail/news/2024/08/20/combining-two-diabetes-drugs-helps-promote-weight-loss-and-blood-sugar-control?SSO=Y

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