NCT02851849

A Study of LGD-6972 in Patients With Type 2 Diabetes Mellitus

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety and Efficacy of LGD-6972 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Ligand Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c) during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects with Type 2 Diabetes Mellitus (T2DM)

Detailed description

This will be a 12-week, randomized, double-blind, placebo-controlled, 4-arm, parallel group, multi-center study to evaluate the safety and efficacy of LGD-6972 in subjects with T2DM inadequately controlled on metformin monotherapy (a stable \[≥12 weeks\], daily dose of ≥1000mg at randomization). Subjects with T2DM will be treated with one of 3 dose levels of LGD-6972 (5 mg, 10 mg, or 15 mg) or placebo once daily (QD) for 12 weeks. Randomization will be stratified by HbAlc ≤8.5% or \>8.5% at the Placebo Lead-in Visit. Qualified subjects who require adjustment or stabilization of their metformin dose will participate in a run-in period of up to 12 additional weeks prior to randomization. Subjects will have the option to participate in an oral glucose tolerance test (OGTT) at baseline and end of treatment for assessment of exploratory endpoints.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	LGD-6972-5 mg	5 mg LGD-6972 QD
DRUG	LGD-6972-10 mg	10 mg LGD-6972 QD
DRUG	LGD-6972-15 mg	15 mg LGD-6972 QD
OTHER	Placebo	Placebo QD

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-08-02
• Last updated: 2018-01-12

Locations

29 sites across 1 country: United States