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

Phase 2

• Conditions: Impaired Glucose Tolerance; Insulin Resistance
• Interventions: Drug: Placebo capsules; Drug: LIM-0705

• Registration Number: NCT01364155
• Lead Sponsor: Limerick BioPharma

Brief 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

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-05
• Study First Submitted: 2011-05-25
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• males and females, age 18-75 years old, able and willing to provide written informed consent to participate in the study
• obesity-induced impaired glucose tolerance or abnormal HOMA-IR
• waist circumference of 40 inches or greater (men) or 35 inches or greater (women)
• good physical health based on EKG, electrolytes, LDH, creatinine, urea, AST, ALT, alkaline phosphatase, and renal function
• male subjects who are sexually active with a female partner of childbearing age must agree to use of 2 effective methods of contraception, including the use of a condom, throughout the course of the study or provide proof of surgical sterility. The second method of contraception must be the use by their female partners of any of the following: a diaphragm with spermicide, a cervical cap with spermicide, an IUD, a female condom, or an approved hormonally based contraceptive (e.g., an oral, transdermal, or implanted estrogen or progestin). Female subjects must be post menopausal or surgically sterile.

Exclusion Criteria

• BMI equal to or greater than 40 kg/m2
• allergy to onions or red wine
• strict vegetarians
• use of any non-study medications other than thyroid replacement hormone or anti-hypertensives. Use of cardesarten cilexetil is not permitted. Note: acetaminophen should not be administered.
• use of chemotherapy agents or history of cancer, other than non-metastatic non-melanoma skin cancer that has been completely excised, within 5 years prior to the screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo LIM-0705 for 28 days	Placebo capsules	-
600 mg LIM-0705 BID for 28 days	LIM-0705	-

Primary Outcome Measures

Name	Time	Method
Evaluate the safety (number of subjects with adverse events) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR	28 days

Secondary Outcome Measures

Name	Time	Method
Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC).	28 days
Explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with impaired glucose tolerance or abnormal HOMA-IR as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27	28 days
Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels	28 days
Evaluate the tolerability (BID) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR	28 days

Trial Locations

Locations (1)

Profil Institute of Clinical Research, Inc.; 🇺🇸 Chula Vista, California, United States