DOYLESTOWN, PA — Metabolics Pharma has announced top-line results from a Phase 1a clinical trial of ENT-03, its investigational drug for obese and diabetic patients. The trial demonstrated that ENT-03 was safe and well tolerated at all doses tested, with encouraging trends in weight loss and improved insulin sensitivity observed at higher doses. The findings were presented at the American Diabetes Association 85th Scientific Sessions on June 22, 2025.
ENT-03 is a novel, centrally acting aminosterol with Protein Tyrosine Phosphatase 1B (PTP1B) inhibitory activity. It works by targeting brain circuits to normalize glucose levels, improve insulin sensitivity, and promote weight loss. Preclinical studies have shown that ENT-03 is effective as a standalone treatment and has an additive effect when combined with GLP1 agonists. Additionally, the drug has demonstrated durable impacts on weight loss and metabolic normalization after therapy cessation in animal models.
“Our first-in-human study has demonstrated that ENT-03 is safe and very well tolerated and showed positive trends in both weight loss and insulin sensitivity that are consistent with what we have seen in preclinical in vivo studies,” said Richard Larson, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of Metabolics Pharma. “We are planning a Phase 1b study to evaluate dosing regimens, which we expect to initiate in the second half of 2025.”
The Phase 1a trial, a single ascending dose study, evaluated seven dose cohorts of ENT-03 administered subcutaneously in both healthy obese individuals and obese patients with type 2 diabetes (T2D). The primary endpoint focused on safety, tolerability, and pharmacokinetics, while secondary endpoints measured fasting blood glucose, fasting insulin, lipid levels, and weight changes over seven days.
Results indicated ENT-03 was very well tolerated across all dose levels. Positive trends in weight loss and enhanced insulin sensitivity were observed at higher doses in both obese and obese/T2D subjects.
With these early results, Metabolics Pharma is optimistic about the potential of ENT-03 to address obesity and diabetes, two major public health challenges, and looks forward to advancing the drug into its next phase of clinical development later this year.
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