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

Limerick BioPharma

Status and phase: Unknown; Phase 2

Conditions: Impaired Glucose Tolerance; Insulin Resistance

Treatments: Drug: LIM-0705; Drug: Placebo capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01364155

LIM-0705-CL-2001

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

600 mg LIM-0705 BID for 28 days

Experimental group

Treatment:

Drug: LIM-0705

Placebo LIM-0705 for 28 days

Placebo Comparator group

Treatment:

Drug: Placebo capsules