Clinical Trial Details

NCT ID: NCT02851849
Date Last Changed: November 19, 2016

Overview

Research Study Summary

A Phase 2 clinical study for patients with Type 2 Diabetes Mellitus

Research Study Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety and Efficacy of LGD-6972 in Patients With Type 2 Diabetes Mellitus

Purpose

The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c) during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects with Type 2 Diabetes Mellitus (T2DM)

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
21 to 70 Years
Overall Status
Recruiting
Lead Sponsor
Ligand Pharmaceuticals
Duration
14 Months
Facility Type
N/A
Compensation

Eligibility

All ages 21 Years to 70 Years

Inclusion Criteria:

  1. Female subjects must be surgically sterile (hysterectomy or bilateral oophorectomy or bilateral tubal ligation), or naturally post-menopausal for at least 12 months and with a follicle stimulating hormone (FSH) level in the post-menopausal range (if not taking hormone replacement therapy)

  2. Male subjects must either have a vasectomy or agree that they and any female partners will use 2 acceptable forms of contraception, one of which must be a condom, until 30 days after the last dose of study drug. Other acceptable forms of contraception include hormonal contraceptives that have been at stable dose for 12 weeks prior to randomization, intrauterine device, Depo-Provera®, Norplant® System Implants, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, and contraceptive sponge, foam, or jelly. Also, male subjects must not donate sperm during the study and for 30 days after the last dose of study drug

  3. Willing and able to provide written informed consent

  4. Diagnosis of T2DM according to American Diabetes Association criteria

  5. Currently on stable metformin or metformin extended-release therapy (unchanged dose [minimum daily dose of 1000 mg] for ≥12 weeks prior to screening)

  6. Subjects must have an HbA1c value of ≥7.0% to ≤10.5%

  7. Subjects must have a fasting plasma glucose of ≤260 mg/dL

  8. Subjects must have a body mass index (BMI) between 25 kg/m2 and 40 kg/m2, inclusive, and must weigh more than 45 kg

Exclusion Criteria:

  1. History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia or hypoglycemia unawareness

  2. Women of childbearing potential, lactating, or has a positive pregnancy test

  3. History or presence of alcoholism or drug abuse within 2 years prior to screening

  4. Unwilling to comply with study restrictions, including restrictions on strenuous exercise

  5. Presence of any of the following conditions: renal impairment (defined as history or estimated glomerular filtration rate at screening of < 45 mL/min using the Modification of Diet in Renal Disease equation), diabetic proliferative retinopathy, severely symptomatic diabetic neuropathy requiring treatment, diabetic gastroparesis, active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, symptomatic gall bladder disease, or pancreatitis

  6. Serum triglyceride level > 400 mg/dL at screening

  7. Liver transaminase levels (AST or ALT) > 150% ULN, total bilirubin > 2 ULN, or creatine kinase (CK) levels > 3 × ULN at screening

  8. History or evidence of clinically significant cardiovascular, pulmonary, renal, endocrine (other than T2DM), hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease or surgical intervention (eg, bariatric surgery) or allergic conditions (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

  9. Myocardial infarction, unstable angina, arterial revascularization, stroke, symptomatic peripheral artery disease, deep vein thrombosis, New York Heart Association Functional Class III or IV heart failure, or transient ischemic attack within 6 months prior to screening

  10. History of malignant hypertension or a recent history of uncontrolled high blood pressure or at screening has a seated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg after at least a 5 minute rest. Blood pressure is determined as the mean of triplicate measurements collected at 2- minute intervals after the subject has been sitting quietly for at least 5 minutes. Therapy for hypertension (beta blockers excluded) that has been stable for at least 8 weeks prior to screening is permitted

  11. Arm size in excess of the maximum limit of the largest cuff provided with the study blood pressure monitor

  12. History of malignancy (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ) within 5 years prior to screening

  13. History or evidence of QT prolongation or clinically significant QT prolongation (QTcF > 450 msec) at screening, or other significant ECG findings at screening that may place the subject at increased risk by participating in the study

  14. Treatment with any type of insulin (injected or inhaled) for > 6 consecutive days within 6 months prior to screening or any insulin therapy within 12 weeks prior to screening

  15. Treated with peroxisome proliferator-activated receptor-gamma agonists (thiazolidinediones [TZDs]), incretin therapy (GLP-1 agonists). or amylin mimetics within 12 weeks prior to screening

  16. Taking any of the following prohibited medications

  17. Antidepressants, antipsychotics, anti-epileptics, hormone replacement therapies (estrogen, progestin), testosterone therapies, and thyroid replacement medications that are not at a stable dose for at least 12 weeks prior to screening

  18. Lipid-modifying medications and anti-hypertensive medications that have not been at a stable dose for at least 8 weeks prior to the Screening Visit (excluding bile acid sequestrants, ezetimibe, and beta blockers, which are prohibited

  19. Over-the-counter herbal medications and supplement (aside from once daily multivitamins)

  20. Treatment with systemic corticosteroids, which must be discontinued at least 4 weeks prior to screening. Note: Inhaled, intraarticular, intranasal and topical corticosteroids are permitted

  21. Currently treated with weight-loss medications. These must be discontinued ≥12 weeks prior to screening

  22. History or evidence of intravenous illicit drug use, active hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) infection

  23. Known hypersensitivity or idiosyncratic reaction to glucagon receptor (GCGR) antagonists or LGD-6972

  24. Participation in another interventional clinical trial within 30 days prior to dosing or treatment with an investigational product with 14 days or 5 half-lives of the Screening Visit (whichever is longer)

  25. Donated ≥ 450 mL of blood within 56 days of screening or has donated blood products within 30 days of screening

  26. Inability to comply with study procedures or to adhere to study-required restrictions

Site Locations (28)

Country State City Zip Facility and Contact
United States Alabama Tuscumbia 35674 Research Site
United States Arizona Chandler 85224 Research Site
United States Arizona Surprise 85374 Research Site
United States California Huntington Park 90255 Research Site
United States California Los Angeles 90057 Research Site
United States California Montclair 91763 Research Site
United States California North Hollywood 91606 Research Site
United States California San Diego 92161 Research Site
United States Colorado Denver 80209 Research Site
United States Florida Brooksville 34601 Research Site
United States Florida Hialeah 33014 Research Site
United States Florida Tampa 33607 Research Site
United States Illinois Chicago 60607 Research Site
United States Nevada Las Vegas 89119 Research Site
United States New Mexico Albuquerque 87102 Research Site
United States New York Hopewell Junction 12533 Research Site
United States North Carolina Greensboro 27410 Research Site
United States Ohio Columbus 43214 Research Site
United States Ohio Franklin 45005 Research Site
United States Ohio Munroe Falls 44262 Research Site
United States South Carolina Summerville 29485 Research Site
United States Texas Carrollton 75007 Research Site
United States Texas Dallas 75230 Research Site
United States Texas Houston 77036 Research Site
United States Texas Houston 77074 Research Site
United States Texas Houston 77099 Research Site
United States Texas Katy 77450 Research Site
United States Virginia Manassas 20110 Research Site

Contact

Keith Marschke, Ph.D.
858-550-7734
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.