Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2018-11-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Must have given written informed consent and be able to comply with all study requirements.

• Males or females aged 18-75, inclusive, at the time of Informed Consent.

• Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal.

• Males must be surgically sterile, abstinent or using an acceptable contraceptive method.

• Body mass index (BMI) ≥ 27.0 - ≤ 39.0 kilograms per square meter (kg/m^2).

• Diagnosis of Type 2 Diabetes Mellitus with an Hemoglobin A1C (HbA1c) ≥7.3% and ≤9.5% at screening.

• Must have been on a stable dose of Oral Antidiabetic Therapy for a minimum of 3 months prior to Screening.

• ≥ 10% liver fat prior to randomization assessed by MRI-PDFF.

• Stable body weight for at least 3 months before screening.

Exclusion Criteria:

• Clinically-significant abnormalities in medical history or physical examination.

• Clinically-significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion, per Sponsor.

• Evidence of uncorrected hypothyroidism or hyperthyroidism results at Screening.

• History of solid organ transplantation or renal dialysis.

• Clinically-significant complications of diabetes.

• Treatment with another Study Drug, biological agent, or device within one-month of screening.

• Known history or evidence of liver disease with a positive test for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), or chronic Hepatitis B virus (HBV), or chronic liver disease other than NASH.

• Recent history of, or current drug or alcohol abuse.

• Current use of concomitant medications known to significantly impact body weight or that may cause liver toxicity, per Investigator

• Use of anticoagulant/Antiplatelet agents unless the dose has been stable for 4 weeks prior to the first dose of study drug]

• Use of non-steroidal anti-inflammatory drug nimesulide or any other drug influencing coagulation (except lose-dose aspirin).

• Use of obeticholic acid or ursodeoxycholic acid

• Considered unsuitable for inclusion by the Principal Investigator