NCT03371355

Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Akcea Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, Type 2 diabetes mellitus (T2DM), and nonalcoholic fatty liver disease (NAFLD).

Conditions

• NAFLD
• Diabetes Mellitus, Type 2
• Hypertriglyceridemia
• Fatty Liver, Nonalcoholic

Interventions

Type	Name	Description
DRUG	Placebo	Placebo (Matched with ISIS 703802)
DRUG	ISIS 703802 40 mg	ISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses.
DRUG	ISIS 703802 80 mg	ISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses.
DRUG	ISIS 703802 20 mg	ISIS 703802 20 mg, administered via SC injection, once every week for 26 doses.

Timeline

• Start date: 2017-12-21
• Primary completion: 2019-11-21
• Completion: 2020-02-24
• First posted: 2017-12-13
• Last updated: 2021-02-01
• Results posted: 2021-02-01

Locations

42 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study