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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Impaired Glucose Tolerance, Insulin Resistance

In brief

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.

Key facts

Study ID

NCT01364155

Run by

Limerick BioPharma

People needed

50

Starts

2011-05-01

Expected to finish

2011-08-01

Last updated by the study team

2011-06-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Profil Institute of Clinical Research, Inc. — Chula Vista, California, United States (enrolling)

Full record on ClinicalTrials.gov

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