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

Primary Purpose

Impaired Glucose Tolerance, Insulin Resistance

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LIM-0705

Placebo capsules

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Profil Institute of Clinical Research, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

600 mg LIM-0705 BID for 28 days

Placebo LIM-0705 for 28 days

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC).

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

Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels

Evaluate the tolerability (BID) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR

Full Information

NCT ID

NCT01364155

First Posted

May 25, 2011

Last Updated

May 31, 2011

Sponsor

Limerick BioPharma

1. Study Identification

Unique Protocol Identification Number

NCT01364155

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

August 2011 (Anticipated)

Study Completion Date

August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Limerick BioPharma

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Glucose Tolerance, Insulin Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

600 mg LIM-0705 BID for 28 days

Arm Type

Experimental

Arm Title

Placebo LIM-0705 for 28 days

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LIM-0705

Intervention Type

Drug

Intervention Name(s)

Placebo capsules

Primary Outcome Measure Information:

Title

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC).

Time Frame

28 days

Title

Time Frame

28 days

Title

Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels

Time Frame

28 days

Title

Evaluate the tolerability (BID) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Morrow, MD

Organizational Affiliation

Profil Institute of Clinical Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Institute of Clinical Research, Inc.

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Morrow, MD

Phone

619-409-1268

12. IPD Sharing Statement

Learn more about this trial

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

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