Status:
COMPLETED
Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Hepatic Steatosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03334214
Start Date
November 3 2017
End Date
November 28 2018
Last Update
January 27 2020
Active Locations (22)
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1
Ionis Investigational Site
Halifax, Nova Scotia, Canada, B3H 2Y9
2
Ionis Investigational Site
Chicoutimi, Quebec, Canada, G7H 7K9
3
Ionis Investigational Site
Budapest, Hungary, 1036
4
Ionis Investigational Site
Budapest, Hungary, 1083