Safety and Tolerability Study of Oral LGD-6972 for Type 2 Diabetes Mellitus — L6972-02  

Type 2 Diabetes Mellitus Clinical Trial

Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LGD-6972 in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Status Completed

Clinical Trial Summary

Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose production characteristic of type 2 diabetes mellitus that is a major contributor to hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with type 2 diabetes mellitus.

Clinical Trial Description

This is to be a randomized, double-blind, placebo-controlled, sequential, multiple oral dose study conducted in normoglycemic healthy subjects (NHS) (Part 1) and subjects with type 2 diabetes mellitus (T2DM) who are treated with monotherapy metformin (a stable dose at randomization) along with diet and exercise (Part 2). Subjects with T2DM who are not on a stable dose of metformin but meet all other entry criteria may be enrolled in the study at the discretion of the Investigator, but must undergo a stabilization period of at least 12 weeks before determining eligibility for the study. In Part 1, a single group of healthy subjects will be dosed with repeated oral doses of 15 mg of LGD-6972 or placebo once daily (QD) for 14 days. In Part 2, a maximum of 3 groups of subjects with T2DM will be dosed with 3 sequential, increasing doses of LGD-6972 (5 mg, 10 mg or 15 mg) or placebo QD for 14 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT02250222
• Study type: Interventional
• Source: Ligand Pharmaceuticals
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Completion date: June 2015