Cumberland

This research aims to evaluate the safety and effectiveness of increasing doses of NNC0662-0419 for adults living with obesity. The study is a phase 2 randomized trial comparing different dosing approaches of NNC0662-0419 and semaglutide, both administered by subcutaneous injection. Participants include adults with obesity who are committed to losing at least 25% of their body weight. Participants are randomly assigned to one of four groups receiving either NNC0662-0419 or semaglutide, or their matching placebos. All treatments are given by subcutaneous injection in a dose-escalation manner, meaning doses increase over time. This allows researchers to compare the safety and response to these drugs and their placebos. Throughout the study, participants are monitored for gastrointestinal side effects from week 0 to week 39. Body weight and body mass index BMI changes are also measured from week 0 to week 32. Participants will attend regular visits for dosing, safety assessments, and evaluations of weight and related health measures. The trial is expected to last until July 2027.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults with excess body weight. This phase 3 clinical trial compares weekly injections of NNC0487-0111 against placebo injections, both given under the skin. Participants also follow a reduced-calorie diet and increased physical activity as part of the study. Participants receive subcutaneous injections once a week of either NNC0487-0111 or a placebo. The study uses a randomized, parallel design with quadruple masking to assign treatments by chance. Treatments are given alongside lifestyle changes involving diet and exercise. During the trial, participants will be monitored over 92 weeks with regular assessments including body weight, waist circumference, blood pressure, blood sugar markers, cholesterol levels, and quality of life questionnaires. Safety is evaluated by tracking any adverse events. The primary measurement is the relative change in body weight from week 40 to week 92. The study is sponsored by Novo Nordisk AS and runs until mid-2028.

This research aims to find out if NNC0487-0111 is safe and effective for adults with excess body weight. The study compares this medicine to a placebo in people who have a history of unsuccessful attempts to lose weight through diet. It is a phase 3 clinical trial that evaluates treatment for obesity, focusing on weight loss and related health measures. Participants receive weekly injections under the skin with either NNC0487-0111 at one of four dose levels or a placebo. These injections are given using pre-filled pen-injectors to the thigh, abdomen, or upper arm. All participants follow a reduced-calorie diet and increase physical activity during the study. The trial lasts up to 136 weeks, with treatment and follow-up periods designed to assess long-term effects. Throughout the study, participants attend regular visits where researchers measure changes in body weight, waist circumference, blood pressure, blood sugar levels, cholesterol, and quality of life scores. Safety is monitored by tracking any adverse events during and after treatment. The main outcome is the relative change in body weight from the start of the study to week 84, with continued observation up to week 136. Participants remain under medical supervision throughout the trial.

Researchers are evaluating a multi-level approach called the Science of Service Laboratory to increase the use of contingency management for stimulant use among people receiving medication for opioid use disorder. This study focuses on public sector addiction specialty treatment programs and aims to improve both how contingency management is implemented and patient outcomes. The trial addresses the gap in using contingency management, an evidence-based intervention for stimulant addiction, within opioid treatment programs. The study uses a stepped wedge design where addiction programs are randomized in cohorts to receive the Science of Service Laboratory strategy. This approach includes didactic training with workshops and coaching calls, performance feedback through practice sessions and electronic medical record data, and external facilitation with monthly calls. Programs start with usual care and then transition to the implementation strategy, allowing comparison before and after the intervention. Participants include opioid treatment program counselors providing psychosocial support and patients newly started on medication for opioid use disorder who also use stimulants. Data collected include de-identified electronic medical records on contingency management delivery and patient outcomes, alongside staff reports on implementation factors. Primary outcomes focus on changes in the percentage of patients receiving contingency management and counselors delivering it over 10 months. Secondary outcomes include stimulant abstinence measured by toxicology screens and the number of contingency management sessions.

Researchers are evaluating two treatment options for people with type 2 diabetes who also have established or high-risk atherosclerotic cardiovascular disease ASCVD. This clinical trial aims to compare the total number of heart, kidney, and death events between treatments using sodium-glucose cotransporter-2 inhibitors SGLT2i and glucagon-like peptide-1 receptor agonists GLP-1 RA. The study involves 6,000 participants and seeks to better understand how these medications affect health outcomes in this population. Participants will be randomly assigned to receive either an SGLT2 inhibitor canagliflozin, dapagliflozin, or empagliflozin or a GLP-1 receptor agonist dulaglutide, liraglutide, or semaglutide, all of which have shown cardiovascular benefits. The study is open label, meaning both participants and researchers know which treatment is given. Treatment assignment is balanced evenly between the two groups, and participants will continue their assigned therapy throughout the study. During the trial, researchers will monitor participants for events including heart attacks, strokes, arterial revascularization, hospitalizations for heart failure, kidney failure, kidney transplants, and death. Follow-up will last for an average of about three years. Data will be collected through medical records and electronic health information, with ongoing tracking of health status and treatment adherence to assess the total number of these cardiovascular and kidney-related events.

Researchers are studying perinatal health outcomes in Rhode Island, focusing on improving maternal and infant health by addressing social determinants of health SDOH such as food, housing, and transportation. The project aims to reduce adverse outcomes and racial disparities by integrating hospital services with community health workers, doulas, and community organizations. This effort is structured as a stepped wedge cluster randomized trial across six prenatal clinics over four years. The study involves implementing the Community-based Maternal Support Services COMSS program, which includes universal screening for risk factors at multiple prenatal and postpartum visits. Patients who screen positive receive coordinated care from care managers and community health workers, including doula care and referrals to address social needs. The intervention is introduced sequentially to all clinics, and data will be collected before and after the program to evaluate its impact. Participants will undergo screenings at their first prenatal visit, second and third trimesters, delivery, and 2-6 weeks postpartum. Those identified with risks will receive ongoing support and follow-up, with care continuing until at least three months postpartum before transitioning to primary care. Researchers will assess outcomes such as rates of severe maternal morbidity and mortality, cesarean births, prenatal care adequacy, postpartum depression screening, substance abstinence during pregnancy, infant death, and preterm birth.