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

NCT02250222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LGD-6972

LGD-6972 sodium salt powder in Captisol ® (betadex \[β-cyclodextrin\] sulfobutylether sodium, NF)

DRUG

Placebo (Captisol ®)

betadex \[β-cyclodextrin\] sulfobutylether sodium, NF

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Keith Marschke, Ph.D. · Ligand Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250222 on ClinicalTrials.gov