Efficacy and safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4mg) once-weekly compared to tirzepatide 15 mg s.c. once-weekly in participants with obesity

Date Added
November 1st, 2023
PRO Number
Pro00131916
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

An 81-week clinical research study to compare the effect on body weight loss of CagriSema 2.4 mg vs. tirzepatide (known as Mounjaro) 15 mg weekly, along with a reduced-calorie diet and increased physical activity in participants with obesity.
The medicines are injected subcutaneously (under the skin) once a week.

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

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

Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step from the ORBIT Initiative

Date Added
January 5th, 2021
PRO Number
Pro00106021
Researcher
Phillippe Cunningham

List of Studies


Keywords
Adolescents, Minorities, Obesity
Summary

The purpose of this study is to test the effectiveness of a comprehensive treatment for African-American adolescents with obesity and their overweight or obese caregiver (e.g., parent). Families who decide to participate in this study will be randomly assigned to one of two intervention groups: the FIT Families group or the Home-Based Family Support (HBFS) group. This means participants have a 50/50 chance (like flipping a coin) of being in either group. Participants randomized to FIT Families will have sessions with a community health worker (CHW) in the home or community once or twice weekly based on the family's preference for the first three months, and weekly for the second three months. Some of the sessions might occur virtually (online) if needed. Participants randomized to HBFS will receive six months of weekly family counseling in their home or community with a community health worker (CHW). Some of these sessions might occur virtually (online) if needed. Participants in both groups will receive education and support for healthier lifestyles.
The study will last 18 months. During the 18-month study period, youth and caregivers will wear a FitBit activity tracker during the six months of the intervention and then for 2 weeks at the fourth assessment, complete study assessments, have their height, weight, and blood pressure measured, and provide finger prick blood samples to be tested for blood sugar and cholesterol levels.
Potential benefits to caregivers and youth who participate in the study include: positive changes in healthy lifestyle behaviors and weight loss, decrease in health risks associated with obesity, and improved family relations, though these cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Elizabeth O'Brien
843-876-0219
obriene@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



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