A new oral GLP-1 receptor agonist, RGT-075, developed by Regor Therapeutics, has shown promising results in helping patients with obesity or overweight lose weight. In a phase 2a trial, RGT-075 demonstrated a statistically significant 5% placebo-adjusted weight loss in adult patients, with no plateau in weight loss observed up to 12 weeks. This new treatment, which is also being studied for type 2 diabetes, is an orally bioavailable, small molecule designed to provide sustainable weight loss solutions for individuals struggling with obesity and related health issues.
Trial Details and Results
The trial involved 73 adult patients aged 18 to 75 years with a BMI of 27 kg/m² or higher. Participants were randomly assigned to receive either RGT-075 (125 mg once-daily) or a placebo for 12 weeks. The study found that patients who received RGT-075 experienced an average 5% weight loss, significantly outperforming the placebo group. Moreover, there was no weight loss plateau throughout the duration of the study.
The trial was multicenter, double-blind, and placebo-controlled, with participants from 10 clinical centers across the United States. One patient required a dose reduction, but the treatment continued to be effective. Side effects, such as nausea and vomiting, were reported in 40% and 24% of patients, respectively, with discontinuation rates due to adverse events identical between the treatment and placebo groups.
The Future of RGT-075
Xiayang Qiu, PhD, CEO of Regor Therapeutics, emphasized the importance of developing an oral version of GLP-1 drugs. He highlighted the benefits of oral small molecules for long-term use, their ease of manufacturing, and their potential for wider accessibility to the millions of individuals affected by obesity and weight-related comorbidities.
Regor Therapeutics is moving forward with further trials for RGT-075. The upcoming phase 2b trial, COMO-1, will evaluate multiple doses of RGT-075, including up to 225 mg over 36 weeks. This trial will involve 240 patients and aim to assess the percent change in body weight. Results from this trial are expected by the end of 2025.
This phase 2a study marks a promising step forward in providing an effective, accessible treatment for weight loss, potentially improving outcomes for individuals struggling with obesity.
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