A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients

Summary

This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48 subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups. Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 \[End of Study (EOS)\] or Early Termination (ET).

Timeline

Start

2022-08-03

Primary completion

2023-03-14

Completion

2023-03-14

Publications

• Bryant CLN, Colbert K, Hompesch M, Chaves S, Nimgaonkar A, Fineman MS. GLY-200, an oral pharmacologic duodenal exclusion drug, resulted in positive effects on glucose, lipids and bodyweight in patients with type 2 diabetes: Results of a randomized, double-blind placebo-controlled trial. Diabetes Obes Metab. 2025 Oct;27(10):5996-6005. doi: 10.1111/dom.16664. Epub 2025 Aug 6.

Drugs

Indications