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

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies


Keywords
Body Composition, Cardiovascular, Drug Studies, HIV / AIDS, Healthy Volunteer Studies, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu

A Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma

Date Added
February 28th, 2017
PRO Number
Pro00062918
Researcher
David Koch

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Digestive System, Genetics, Liver, Obesity, Weight Control
Summary

TARGET-HCC is a 15-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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