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.
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.
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.
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.