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

NCT03371355 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-02-01

Study results available
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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

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.

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Akcea Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2019-11-21
Completion
2020-02-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371355 on ClinicalTrials.gov