NCT01364155

Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR

A Randomized, Single-Blind, Placebo-Controlled Phase 2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Limerick BioPharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral effects on weight in obese and diabetic rodent models. Results from a Phase 1b clinical study, conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be potential insulin sensitizers by OGTT.

Detailed description

The primary objective of the study is to evaluate the safety and tolerability of LIM-0705 administered for 28 days in adult males and females with impaired glucose tolerance or abnormal HOMA-IR. Secondary Objectives include: * examine the pharmacokinetics (PK) of LIM-0705 * explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with impaired glucose tolerance (defined as two-hour plasma glucose levels of ≥140 to ≤199 mg per dL \[7.8 to 11.06 mmol/L\] on the 75-g oral glucose tolerance test \[OGTT\]) or abnormal HOMA-IR (HOMA-IR value ≥ 2.5) as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27 * explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels

Conditions

• Impaired Glucose Tolerance
• Insulin Resistance

Interventions

Type	Name	Description
DRUG	LIM-0705
DRUG	Placebo capsules

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-06-02
• Last updated: 2011-06-02

Locations

1 site across 1 country: United States