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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. 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 taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.
Actively Recruiting
Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.
Actively Recruiting
Researchers are evaluating the efficacy, safety, and tolerability of a study drug called elecoglipron compared with oral semaglutide in adults with Type 2 Diabetes Mellitus T2DM who have an increased risk of cardiovascular events. The study focuses on adults whose diabetes is not adequately controlled by lifestyle changes or stable treatment with other glucose-lowering medications. This is a phase III randomized trial sponsored by AstraZeneca, aiming to compare these two oral medications in managing T2DM and cardiovascular risk. Participants will be assigned to receive either elecoglipron or semaglutide, both administered orally once daily at specified doses. The study runs in parallel groups, with one group receiving elecoglipron and the other receiving semaglutide. Treatment and observation will continue for 52 weeks, during which the effects on blood sugar control and other health indicators will be evaluated. Throughout the 52-week study period, participants will undergo regular assessments including measurements of Hemoglobin A1c HbA1c, body weight, and blood pressure. Researchers will monitor changes from baseline to week 52 to understand the drugs impact on diabetes control and cardiovascular risk factors. The study also tracks safety and tolerability to ensure participant wellbeing during the trial.
Actively Recruiting
Researchers are evaluating BNT3214, also known as PM8102, in adults with advanced solid tumors in this early-phase clinical trial. The study aims to determine the safety and initial effectiveness of BNT3214, marking its first testing in people. The trial consists of three parts Parts A and B focus on finding the safest and best dose levels, while Part C tests selected doses in various types of cancer. An internal review committee oversees safety and dosing decisions throughout the study. Participants receive intravenous infusions of BNT3214 in varying dose levels. Parts A and B explore dose escalation and alternative dosing schedules to identify optimal dosing. Part C includes dose optimization and expansion cohorts without randomization in most parts, except for dose optimization cohorts where participants may be randomized between two dose levels. Treatment continues up to two years or until disease progression, unacceptable side effects, or other stopping criteria. During the study, participants undergo regular safety and response assessments, including monitoring for side effects, dose adjustments, and evaluation of tumor response based on standard criteria. Blood samples will be collected for pharmacokinetic and antibody testing. Researchers will measure outcomes such as treatment-emergent adverse events, dose-limiting toxicities, and objective response rates over up to 30 months. The study includes thorough safety monitoring until 90 days after the last dose, with participants followed for up to two years or until other study-defined endpoints occur.
Actively Recruiting
Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.
Actively Recruiting
This research evaluates the effects of ribupatide KAI-9531 given as a weekly subcutaneous injection compared to a placebo. It focuses on adults living with obesity or overweight who also have weight-related health issues but do not have diabetes. The study aims to understand how ribupatide influences body weight changes over time. Participants are randomly assigned to one of several groups receiving different doses of ribupatide once weekly or a matching placebo injection once weekly. The study is double-blind, so neither participants nor researchers know who receives the drug or placebo. Dosages range from Dose 1 to Dose 4, and the treatment period lasts up to 76 weeks. During the study, participants will have their body weight and various health indicators measured, including waist circumference, blood pressure, cholesterol levels, blood glucose, and quality of life related to weight. Safety is monitored by tracking adverse events and immune responses to the drug. The trial spans over approximately 76 weeks, with assessments at baseline and week 76 to evaluate changes and effects.
Actively Recruiting
This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.
Actively Recruiting
Researchers are evaluating the effect of MAR001 compared to a placebo in adults with elevated triglycerides TG and remnant cholesterol RC. This Phase 2b randomized, double-blind, placebo-controlled study aims to understand how MAR001 influences TG levels in participants with these conditions. The study includes two parts with different participant groups based on their baseline TG levels. Participants are assigned randomly to receive either MAR001 or placebo through subcutaneous injections every 4 weeks. Part A includes about 216 participants with baseline TG between 150 to 880 mgdL, treated with three different doses of MAR001 or placebo at a 31 ratio. Part B enrolls around 100 participants with baseline TG between 450 and 2000 mgdL, using the dose selected from Part A data, assigned at a 11 ratio. The study timeline consists of up to 8 weeks of screening, a 24-week treatment period, and a 12-week safety follow-up with clinic visits at weeks 28 and 36. During the study, participants will undergo assessments including blood tests and clinical evaluations to monitor TG and RC levels and safety outcomes. The primary outcome is measured at 12 weeks, with additional secondary outcomes assessed at various time points. Participants adherence to stable diet and medication regimens is monitored. The total participation duration extends through the screening, treatment, and follow-up periods, with safety monitored until study completion.