Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | May 2011 |
| End Date: | August 2011 |
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.
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
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
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
We found this trial at
1
site
Click here to add this to my saved trials
