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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.
Actively Recruiting
Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of sonesitatug vedotin combined with capecitabine, with or without rilvegostomig, as a first-line treatment for people with Claudin18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma. This Phase III study also assesses the performance of investigational in vitro diagnostics used to identify eligible patients. The trial includes two groups based on PD-L1 status and eligibility for immune checkpoint inhibitor therapy. Participants will be assigned to one of several treatment groups. Cohort 1 includes participants who are PD-L1 positive and eligible for immune checkpoint inhibitors, receiving sonesitatug vedotin, rilvegostomig, and capecitabine. Cohort 2 includes PD-L1 negative or ineligible participants receiving sonesitatug vedotin with capecitabine. Other treatment arms involve combinations including nivolumab, zolbetuximab, and chemotherapy regimens such as CAPOX or FOLFOX. During the study, participants will be monitored for up to approximately five years to assess progression-free survival and overall survival. Researchers will also evaluate response rates, duration of response, pharmacokinetics, immunogenicity, safety, and tolerability. Participants will undergo regular assessments, including imaging to measure tumors and laboratory tests to monitor health and treatment effects.