CLINICAL TRIALS PROFILE FOR VOLANESORSEN

Clinical Trials for Volanesorsen

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02211209 ↗	The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome	Completed	Akcea Therapeutics	Phase 3	The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome
NCT02211209 ↗	The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome	Completed	Ionis Pharmaceuticals, Inc.	Phase 3	The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in participants with Familial Chylomicronemia Syndrome
NCT02300233 ↗	The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia	Completed	Akcea Therapeutics	Phase 3	The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in patients with Hypertriglyceridemia
NCT02300233 ↗	The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia	Completed	Ionis Pharmaceuticals, Inc.	Phase 3	The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in patients with Hypertriglyceridemia
NCT02527343 ↗	The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy	Terminated	Akcea Therapeutics	Phase 2/Phase 3	The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.
NCT02527343 ↗	The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy	Terminated	Ionis Pharmaceuticals, Inc.	Phase 2/Phase 3	The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.
NCT02658175 ↗	The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome	Completed	Akcea Therapeutics	Phase 3	An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.

Clinical Trial Conditions for Volanesorsen

Condition Name

Condition Name
Intervention	Trials
Familial Chylomicronemia Syndrome	3
Familial Partial Lipodystrophy	1
Hyperlipoproteinemia Type 1	1
Hypertriglyceridemia	1

Condition MeSH

Condition MeSH
Intervention	Trials
Syndrome	3
Hyperlipoproteinemia Type I	3
Hyperlipoproteinemias	1
Hyperlipidemias	1

Clinical Trial Locations for Volanesorsen

Trials by Country

Trials by Country
Location	Trials
United States	44
Canada	11
Netherlands	6
Germany	5
Spain	5

Trials by US State

Trials by US State
Location	Trials
Texas	5
California	4
Washington	3
Virginia	3
Pennsylvania	3

Clinical Trial Progress for Volanesorsen

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	4
Phase 2/Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for Volanesorsen

Sponsor Name

Sponsor Name
Sponsor	Trials
Ionis Pharmaceuticals, Inc.	8
Akcea Therapeutics	7

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	15