Regor initiates phase 2 study of oral once-daily GLP-1 agonist RGT-075 to treat obesity
Regor Therapeutics Group (Regor), a clinical-stage global biopharmaceutical company, announced that its phase 2 trial of the highly selective oral GLP-1 agonist RGT-075 is initiated in adults with obesity or overweight with weight-related comorbidities and has First Patient First Visit (FPFV) on March 08, 2024.
Words from MD: Regor
- The topline results for this phase 2 trial are expected to be announced in the second half of 2024. “The initiation of the phase 2 trial marks an important milestone in the development of RGT-075 as we believe it could represent a convenient and potentially meaningful alternative to the currently available weight loss treatments,” said Michael Grimm, M.D., Ph.D., head of metabolic diseases at Regor.
- “RGT-075 is designed to be administered orally once daily as a monotherapy or as part of a potential oral combination treatment for obesity. Phase 1 clinical data showed promising exploratory body weight trends despite short treatment duration,” added Dr. Grimm.
About Trial
- The phase 2 multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of once-daily oral RGT-075 compared with placebo in adult patients with obesity or overweight with weight-related comorbidities.
- Approximately 60 adult participants with a BMI = 27 kg/m2 and = 45 kg/m2 will be enrolled and randomized to RGT-075 or placebo.
- The treatment will last 12 weeks; all participants on RGT001-075 will be given RGT-075 once daily (QD) titrated up over 6 weeks, then being maintained with the target dose for 6 weeks.
- Topline data from the phase 2 study are expected to be announced in the second half of 2024.
About RGT-075
- RGT-075 is an oral-available, once-daily, small molecule GLP-1R full agonist discovered and developed by Regor for the treatment of metabolic diseases, such as type-2 diabetes mellitus and overweight/obesity.
- Regor completed its phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) studies.
- RGT-075 was safe and clinically well-tolerated in clinical trials completed to date.
About Regor Therapeutics
- Regor Therapeutics is a global biotech company founded in 2018 by a team of scientists with a proven track record in drug discovery and executive leadership covering full cycle of drug discovery and development.
- By leveraging its industry-leading core strength in rCARD (Computer Accelerated Rational Discovery), Regor has completed 8 PCCs inhouse, with 5 INDs filed, validating Regor’s highly efficient ecosystem for accelerated discovery of innovative therapeutic agents.
