Recruiting
Phase 2

LIM-0705

Sponsor:

Limerick BioPharma

Code:

NCT01364155

Conditions

Impaired Glucose Tolerance

Insulin Resistance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LIM-0705

Placebo capsules

Study Details

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

Study ID

NCT01364155

Start date

May, 2011

Status verified date

May, 2011

Completion date

Aug, 2011

Anticipated

Primary completion date

Aug, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 600 mg LIM-0705 BID for 28 days

placebo comparator: Placebo LIM-0705 for 28 days

Interventions

LIM-0705

Placebo capsules

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 ]

Central Contacts and Locations

Locations

Profil Institute of Clinical Research, Inc.

Recruiting

Chula Vista, California, United States, 91911

Contacts

Linda Morrow, MD

619-409-1268

More Information

Sponsor

Limerick BioPharma

Last update posted

Jun 2, 2011

Last verified

May, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Limerick BioPharma on 2011-06-02.