Impaired Glucose Tolerance, Insulin Resistance
Conditions
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.
Detailed description
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
Interventions
DRUGLIM-0705
DRUGPlacebo capsules
Sponsors
Limerick BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed