A Study of LGD-6972 in Patients With Type 2 Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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)

Key facts

Study ID

NCT02851849

Run by

Ligand Pharmaceuticals

People needed

148

Starts

2016-09-01

Expected to finish

2017-06-01

Last updated by the study team

2018-01-12

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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
• Willing and able to provide written informed consent
• Diagnosis of T2DM according to American Diabetes Association criteria
• Currently on stable metformin or metformin extended-release therapy (unchanged dose [minimum daily dose of 1000 mg] for ≥12 weeks prior to screening)
• Subjects must have an HbA1c value of ≥7.0% to ≤10.5%
• Subjects must have a fasting plasma glucose of ≤260 mg/dL
• Subjects must have a body mass index (BMI) between 25 kg/m2 and 40 kg/m2, inclusive, and must weigh more than 45 kg

You may not qualify if…

• History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia or hypoglycemia unawareness
• Women of childbearing potential, lactating, or has a positive pregnancy test
• History or presence of alcoholism or drug abuse within 2 years prior to screening
• Unwilling to comply with study restrictions, including restrictions on strenuous exercise
• 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
• Serum triglyceride level > 400 mg/dL at screening
• Liver transaminase levels (AST or ALT) >150% ULN, total bilirubin >2 ULN, or creatine kinase (CK) levels > 3 × ULN at screening
• 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)
• 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
• 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
• Arm size in excess of the maximum limit of the largest cuff provided with the study blood pressure monitor
• History of malignancy (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ) within 5 years prior to screening
• 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
• 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
• Treated with peroxisome proliferator-activated receptor-gamma agonists (thiazolidinediones [TZDs]), incretin therapy (GLP-1 agonists). or amylin mimetics within 12 weeks prior to screening
• Taking any of the following prohibited medications
• 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
• 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
• Over-the-counter herbal medications and supplement (aside from once daily multivitamins)
• Treatment with systemic corticosteroids, which must be discontinued at least 4 weeks prior to screening. Note: Inhaled, intraarticular, intranasal and topical corticosteroids are permitted
• Currently treated with weight-loss medications. These must be discontinued ≥12 weeks prior to screening
• History or evidence of intravenous illicit drug use, active hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV) infection
• Known hypersensitivity or idiosyncratic reaction to glucagon receptor (GCGR) antagonists or LGD-6972
• 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)
• Donated ≥ 450 mL of blood within 56 days of screening or has donated blood products within 30 days of screening

Where it is running

• Study site — Tuscumbia, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Surprise, Arizona, United States
• Study site — Huntington Park, California, United States
• Study site — Los Angeles, California, United States
• Study site — Montclair, California, United States
• Study site — North Hollywood, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Brooksville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Hopewell Junction, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Franklin, Ohio, United States
• Study site — Munroe Falls, Ohio, United States
• Study site — Summerville, South Carolina, United States
• Study site — Carrollton, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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