Shots:
- FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26
- Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood glucose & body weight up to 13wks. as well as safety & tolerability
- In a 13wk. P-II US study (n=125), ASC30 achieved statistically significant, dose-dependent PBO-adjusted weight loss of 5.4%, 7.0% & 7.7% at 20, 40 & 60mg, with no plateau observed, ~50% lower vomiting than weekly-titrated orforglipron & GI tolerability comparable to orforglipron (Q4W) in P-III (ATTAIN-1) trial
Ref: PRnewswire | Image: Ascletis | Press Release
Related News: Ascletis Pharma Reports First Patient Dosing with ASC30 in P-IIa Trial for Obese or Overweight Patients
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