A phase 2 clinical trial has shown that HS-20094, a novel dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist, is effective and safe in reducing HbA1c, fasting blood glucose, and body weight in patients with type 2 diabetes.
The randomized, double-blind, placebo-controlled study was conducted by researchers from various institutions across China and presented at the American Diabetes Association Scientific Sessions in Orlando, Florida.
Methods
Patients with poorly controlled type 2 diabetes with a HbA1c between 7%-10%, either on diet and exercise alone or stable with metformin, were randomly assigned to receive HS-20094 (5 mg, 10 mg, or 15 mg), semaglutide (1 mg), or placebo, administered subcutaneously once weekly. The primary outcome was change in HbA1c from baseline to week 4.
Results
HS-20094 at all doses significantly reduced HbA1c compared to placebo, with least square mean (LSM) changes of -0.63%, -0.75%, and -0.84% in the 5 mg, 10 mg, and 15 mg groups, respectively. Semaglutide also demonstrated a significant reduction in HbA1c, with an LSM change of -0.59%. Additionally, HS-20094 and semaglutide led to significant reductions in fasting blood glucose compared to placebo.
HS-20094 at 10 mg and 15 mg doses resulted in significant body weight reductions, with LSM percent changes of -2.51% and -4.41%, respectively. The most common adverse events were decreased appetite, abdominal distension, and vomiting, but the occurrence was not dose dependent. No severe hypoglycemia was reported.
Further studies are needed to confirm these findings and assess the long-term safety and efficacy of HS-20094.
The authors declared having no competing interests.