NCT03334214

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

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of ISIS 484137 (IONIS-DGAT2Rx, an Antisense Inhibitor of Diacylglycerol Acyltransferase 2) Administered Once-Weekly for 13 Weeks in Adult Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 Nonalcoholic steatohepatitis (NASH), obese type 2 diabetes mellitus (T2DM) with elevated HbA1c.

Conditions

• Hepatic Steatosis

Interventions

Type	Name	Description
DRUG	IONIS DGAT2Rx	Single Dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks
DRUG	Placebo	Saline 0.9%

Timeline

• Start date: 2017-11-03
• Primary completion: 2018-11-28
• Completion: 2018-11-28
• First posted: 2017-11-07
• Last updated: 2020-01-27
• Results posted: 2020-01-27

Locations

22 sites across 4 countries: Canada, Hungary, Poland, United Kingdom

Regulatory

• FDA-regulated drug study