Diasome Pharmaceuticals Completes Enrollment in Phase 2b OPTI-2 Trial of HDV-Insulin Lispro for Type 1 Diabetes

Phase 2b OPTI-2 trial to assess liver-targeted insulin’s ability to reduce hypoglycemia and improve postprandial control using Dexcom G7 CGM data

CLEVELAND, OH, UNITED STATES, June 19, 2025 /EINPresswire.com/ -- Diasome Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company advancing portal-hepatic targeted therapies for metabolic diseases, today announced that it has completed enrollment (n = 227) in its Phase 2b OPTI-2 trial evaluating HDV-Insulin Lispro in adults with Type 1 diabetes.

OPTI-2 is a randomized, double-blind, active control study comparing Diasome’s Hepatocyte Directed Vesicle (HDV™) enabled insulin lispro to conventional lispro injected subcutaneously over a six-month treatment period. All study participants are utilizing Dexcom G7 continuous glucose monitors throughout the course of treatment to capture detailed glycemic endpoints.

“Reaching full enrollment is an important milestone for people who rely on insulin every day, and it is a significant step forward in the continued clinical development of HDV Insulin,” said Robert Geho, Chief Executive Officer of Diasome. “OPTI-2 is designed to show that by directing insulin to the liver, where glucose regulation begins, we can meaningfully reduce hypoglycemia and improve post-meal glycemic control. We look forward to reporting topline data early in 2026.”

OPTI-2 is designed to demonstrate that liver-targeted HDV-Insulin can widen the therapeutic window of mealtime insulin by reducing the risk of hypoglycemia while maintaining glycemic control. The trial is being conducted at 26 sites in the United States.

About Diasome Pharmaceuticals
Diasome Pharmaceuticals is developing HDV™—a proprietary phospholipid system that delivers native peptides, proteins, and hormones directly to the portal-hepatic axis, the body’s primary site of glucose and lipid regulation that current therapies often fail to reach. The company is advancing first-in-class therapies designed to enhance the efficacy, safety, and durability of treatment for diabetes, obesity, and related metabolic disorders.

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