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

Ionis Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Hepatic Steatosis

Treatments

Drug: Placebo

Drug: IONIS DGAT2Rx

Study type

Interventional

Funder types

Industry

Identifiers

NCT03334214

ISIS 484137-CS2

2017-003197-13 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This short-term study will assess changes in hepatic steatosis over a 13-week treatment period in a patient population with higher risk for development of Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH), obese type 2 diabetes mellitus (T2DM) with elevated HbA1c.

Enrollment

44 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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