Exploratory Phase 2A, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of HU6 for the Treatment of Subjects with Obese Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
February 14th, 2023
PRO Number
Pro00123447
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Obesity, Weight Control
Summary

Subjects meet inclusion for this study based on obesity (a high body mass index (BMI), which means too much weight for an individual's height), and they have Heart Failure with Preserved Ejection Fraction (HFpEF). This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal.
This study will help to find the best dose of HU6 for treating HFpEF, will help to see its impact on weight reduction, and will help to see its effect on subjects' ability to exercise and on how well they feel.
The study is a placebo-controlled double-blind study that will last approximately 28 weeks. There will be 8 clinic visits (approx. 6-8 hours), and 7 phone visits (approx. 20 minutes). The study drug will be capsules taken orally in the morning before eating.
Possible risks are loose bowel movements/diarrhea which was most prominent within the first 2-3 three weeks of dosing and seemed to improve with time and flushing, especially when alcohol is consumed.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

Effect and safety of semaglutide 7.2 mg once-weekly in participants with obesity

Date Added
December 12th, 2022
PRO Number
Pro00124592
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

This study is designed to evaluate the efficacy and safety of semaglutide s.c. 7.2 mg once-weekly versus placebo and semaglutide s.c. 2.4 mg once-weekly as an adjunct to reduced-calorie diet and increased physical activity in adults with obesity.

The maximum duration of the study intervention for each participant is 72 weeks and the duration of the study for each participant is 81 weeks.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu