Purpose of this Study
The study has a screening period of 8 weeks, a 24 week long treatment period, and a long term extension of 48 weeks where participants can continue to receive the study drug. There are visits approximately 1-2 times a month.
Who Can Participate?
Eligibility
People can join this study if they have obesity, which means a body weight level in a certain range based on BMI. They must also have a type of heart failure called HFpEF, which means the heart pumps well but does not relax and fill the way it should. They cannot have other serious heart problems such as cardiomyopathy, valve disease, problems with the heart lining, or a type of heart failure where the heart is overworking. Some people may already have a heart monitoring device placed in their body, but this is not required to join the study.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DCA08: A Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
Principal Investigator
Marat
Fudim
Protocol Number
PRO00118833
NCT ID
NCT07123779
Phase
I/II
Enrollment Status
Pending Open to Enrollment