Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Limerick BioPharma.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Limerick BioPharma
ClinicalTrials.gov Identifier:
NCT01364155
First received: May 25, 2011
Last updated: May 31, 2011
Last verified: May 2011

May 25, 2011
May 31, 2011
May 2011
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01364155 on ClinicalTrials.gov Archive Site
  • Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Impaired Glucose Tolerance
  • Insulin Resistance
  • Drug: LIM-0705
  • Drug: Placebo capsules
  • Experimental: 600 mg LIM-0705 BID for 28 days
    Intervention: Drug: LIM-0705
  • Placebo Comparator: Placebo LIM-0705 for 28 days
    Intervention: Drug: Placebo capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
United States
 
NCT01364155
LIM-0705-CL-2001
No
Linda Morrow, MD, Profil Institute for Clinical Research, Inc.
Limerick BioPharma
Not Provided
Principal Investigator: Linda Morrow, MD Profil Institute of Clinical Research, Inc.
Limerick BioPharma
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP