Glyscend Therapeutics has initiated a Phase 2 clinical trial of its lead candidate, GLY-200, as a novel oral treatment for obesity. GLY-200 has previously demonstrated clinically meaningful reductions in fasting and postprandial glucose, fasting lipids, body weight, food intake and appetite versus placebo in a completed two-week study in patients with type 2 diabetes, and was also shown to be well-tolerated with no treatment-related safety signals. This ongoing Phase 2 trial is designed to evaluate the efficacy, safety, and tolerability of GLY-200 in people living with obesity, but who are non-diabetic.
GLY-200 is a first-in-class, orally administered, non-absorbed polymeric drug that was designed to target and enhance the natural mucus barrier of the duodenum in the upper small intestine. The duodenal epithelium acts as a nutrient sensing and metabolic signalling centre and has been shown to undergo morphological changes and become dysfunctional in patients with metabolic disease, including obesity and type 2 diabetes.
The enhanced mucus barrier in the duodenum created by GLY-200 is intended to restore and activate beneficial gut-mediated signalling through multiple downstream metabolic pathways, including enhanced release of GLP-1 and PYY, thereby reproducing many of the beneficial effects of bariatric surgery in a non-invasive oral pharmacologic duodenal exclusion approach.
In the ongoing 16-week Phase 2 clinical trial, approximately 70 participants with a BMI between 32-40mg/kg2 will be randomised to receive either 2.0g GLY-200 or placebo twice-daily for 16 weeks. The primary outcome measures will be percent change in body weight from baseline and the proportion of participants who achieve ≥ 5% body weight reduction at Week 16. Additional outcome measures include safety and tolerability, waist circumference, and glycaemic and lipid parameters. Enrolment is underway at five sites across the US, and Glyscend anticipates results from the Phase 2 trial in the first quarter of 2025.
“Advancing GLY-200 into this Phase 2 obesity trial marks another major milestone for Glyscend as we seek to bring innovative oral therapies to patients with metabolic disease,” said Dr Sapan Shah, Ph.Dchief executive officer of Glyscend. “Building on previous clinical data in patients with diabetes, we believe GLY-200 may also provide meaningful weight-loss benefit and a well-tolerated profile for patients with obesity. Given its unique mechanism of oral pharmacologic duodenal exclusion, GLY-200 has the potential to be complementary to existing treatments and could expand the therapeutic arsenal needed to treat the global obesity epidemic.”
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