MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Gelesis Loss Of Weight (GLOW) clinical study is a pivotal, multicenter, double-blind, placebo-controlled study of our lead investigational product candidate, Gelesis100, which is an oral, non-systemic approach to weight loss. The GLOW study was designed to assess change in body weight in adults with overweight or obesity after six months of treatment with Gelesis100.
Main findings from the GLOW study include the following:
- 59% of Gelesis100-treated adults achieved weight loss of at least 5% over six months.
o The new data show that Gelesis100-treated adults fell into two groups: responders, the 6 out of 10 who lost an average of 10% of their total body weight (about 22 pounds) and nearly 4 inches from their waist circumference. Non-responders, the 4 out of 10 who lost an average of 1% of their total body weight (about 2 pounds).
o The complete Gelesis100 treatment group (including both responders and non-responders) demonstrated superiority compared to placebo (–6.4% vs. –4.4%, P=0.0007)
- Successful response to Gelesis100 may be predicted by elevated fasting plasma glucose at baseline or weight loss as early as week 8.
- There was a clear and early separation between responders and non-responders. More specifically, weight loss of at least 3% as early as after eight 8 weeks of treatment predicted clinically meaningful weight loss at six months, with sensitivity and specificity levels exceeding 80%.
- The study also showed that nearly half of the adults with prediabetes or drug-naive type 2 diabetes were super-responders. These individuals, who typically face greater challenges to lose weight, had six times greater odds of being super-responders, compared to placebo (adjusted OR: 6.1, P=0.0071).
- Gelesis100 had a highly favorable safety and tolerability profile.