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

NCT01364155 | Unknown Phase 2

• 1 other identifier: LIM-0705-CL-2001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

600 mg LIM-0705 BID for 28 days

EXPERIMENTAL

Drug: LIM-0705

Placebo LIM-0705 for 28 days

PLACEBO COMPARATOR

Drug: Placebo capsules

Interventions

LIM-0705 DRUG

600 mg LIM-0705 BID for 28 days

Placebo capsules DRUG

Placebo LIM-0705 for 28 days

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Limerick BioPharma: lead

Study Sites (1)

Profil Institute of Clinical Research, Inc.

Chula Vista, California, 91911, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Linda Morrow, MD

  Profil Institute of Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: June 2, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 2, 2011

Record last verified: 2011-05

Locations

US (1)