Apex

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety, how the body absorbs and processes, and the treatment effects of CABTREO lotion when applied to the skin in children aged 9 to 11 years, 11 months who have moderate to severe acne vulgaris. The study is open-label and phase 4, focusing on pediatric participants with specific acne severity and lesion counts on the face and at least one trunk area. The purpose is to understand how well CABTREO works and how safe it is in this age group. Participants will apply CABTREO, a combination gel containing clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15%, to affected areas once each morning for 12 weeks. On study visit days, participants will apply the gel at the study center after assessments. The study includes a main group and a smaller pharmacokinetics PK sub-study group to examine drug levels in the blood. The treatment is a topical gel gently rubbed into the skin. Participants will first complete a screening period of up to 5 weeks to confirm eligibility. During the 12-week treatment, they will attend visits at baseline and Days 14, 15 PK sub-study only, 28, 29 PK sub-study only, 56, and 84. Researchers will monitor safety by tracking any adverse events and measure changes in inflammatory and non-inflammatory acne lesions, as well as global acne severity scores. Participants must follow study instructions and attend visits with their parent or guardian if under age of consent.