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Status unknownNCT01364155Updated Jun 2, 2011

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

A Phase 2 interventional study of LIM-0705 and Placebo capsules in Impaired Glucose Tolerance and Insulin Resistance, sponsored by Limerick BioPharma. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-06-02.

Sponsored by Limerick BioPharma · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Impaired Glucose Tolerance
  • Insulin Resistance
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Limerick BioPharma is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    600 mg LIM-0705 BID for 28 days

    Drug: LIM-0705

  • Placebo comparator
    Placebo LIM-0705 for 28 days

    Drug: Placebo capsules

Interventions

  • DrugLIM-0705
  • DrugPlacebo capsules
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC).

    Time frame: 28 days

  2. 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

    Time frame: 28 days

  3. Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels

    Time frame: 28 days

  4. Evaluate the tolerability (BID) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
  • Profil Institute of Clinical Research, Inc.
    Chula Vista, California 91911, United States
    • Linda Morrow, MD · Contact · 619-409-1268
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01364155
Lead sponsor
Limerick BioPharma
First posted
Jun 2, 2011
Start date
May 2011
Primary completion
Aug 2011 (estimated)
Completion
Aug 2011 (estimated)
Last update
Jun 2, 2011

Study contacts

Linda Morrow, MD
principal investigator · Profil Institute of Clinical Research, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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