Source: GLP1 Weight Loss Compendium
Regor Therapeutics on March 8, 2024Announcement of the Launch of a Phase II Clinical Trial for RGT001-075, a Highly Selective Oral GLP-1 Receptor Agonist, Targeting Adults with Obesity or Overweight and Weight-Related Complications; the First Patient First Visit (FPFV) was on March 8, 2024.The preliminary results of this Phase II clinical trial are expected to be announced in the second half of 2024.
This Phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of once-daily oral RGT001-075 compared to placebo in adult subjects who are obese or overweight with weight-related complications. The study will enroll approximately 60 adult subjects with a BMI ≥27 kg/m² and ≤45 kg/m², who will be randomly assigned to either the RGT001-075 group or the placebo group, with treatment lasting for 12 weeks. During the treatment period, all participants receiving RGT001-075 will be administered once-daily RGT001-075 or a matching placebo, with the first 6 weeks being a dose titration phase, followed by 6 weeks of maintenance at the target dose. The primary outcomes of this Phase II study are expected to be announced in the second half of 2024.RGT001-075 is a small molecule GLP-1R receptor agonist administered orally once daily for the treatment of metabolic diseases, such as type 2 diabetes and overweight/obesity. Regor Therapeutics has completed Phase I single ascending dose (SAD) studies in healthy subjects and multiple ascending dose (MAD) studies in diabetic patients. In the completed clinical trials to date, RGT001-075 has demonstrated good safety and clinical tolerability.Michael Grimm, M.D., Head of Metabolic Diseases at Regor Therapeutics, stated,The launch of this Phase II trial is an important milestone in the development of RGT001-075, as they believe RGT001-075 is a convenient treatment method with the potential to replace current weight loss therapies.RGT001-075 can be taken orally once daily and may potentially be used as a monotherapy or in combination with other drugs for the treatment of obesity in the future. Dr. Grimm further noted, "Phase I clinical data shows that even within a shorter treatment period, we have observed a trend in body weight changes among the exploratory endpoints."▍About Regor Therapeutics
Regor Therapeutics was founded in 2018, with core R&D pipelines including small molecule GLP-1R agonists, HPK1 inhibitors, CDK4 selective inhibitors, CDK2 inhibitors, etc.
Through the industry-leading rCARD™ (Computer Accelerated Research & Development) core advantage, Regor Therapeutics has successfully obtained 8 candidate drugs and submitted 5 clinical research applications, validating Regor’s efficient R&D ecosystem that can accelerate the discovery of innovative therapeutic drugs.Regor Therapeutics' self-developed pipeline focuses on three major therapeutic areas: metabolism, oncology, and autoimmune diseases., including two industry-leading clinical assets: 1) RGT001-075, an oral small molecule GLP1R receptor agonist with best-in-class potential for treating obesity and other diseases; 2) RGT-419B, a unique CDK4+ inhibitor demonstrating excellent single-agent efficacy in refractory ER+/Her2- breast cancer patients.
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