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Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the safety and effectiveness of UBT251, a medicine not yet available for prescription, in adults with type 2 diabetes. This study compares UBT251 with semaglutide, an already approved treatment, and their respective placebos. The goal is to see how well different doses of UBT251 lower blood sugar over time. Participants will be randomly assigned to receive either UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. All treatments are given once weekly by injection under the skin. The study follows participants over several weeks, measuring effects at weeks 16, 28, and 40, focusing on blood sugar control and body weight changes. Throughout the study, participants will have regular assessments including blood tests to measure glycated hemoglobin HbA1c, insulin resistance, beta-cell function, fasting glucose, body measurements, blood pressure, cholesterol levels, and other health markers. Safety is monitored by tracking any adverse events, with total participation lasting up to 40 weeks of treatment plus additional safety follow-up.

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 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.

Researchers are evaluating treatments for participants with KRASNRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer who have previously received chemotherapy. The study compares how long participants remain free of disease progression and the overall survival time when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. This Phase 3 trial focuses on patients who have already undergone prior chemotherapy for their cancer. Participants are randomly assigned to one of two groups. One group receives amivantamab combined with the chemotherapy regimen FOLFIRI, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with the same chemotherapy regimen FOLFIRI. Treatments are given in 28-day cycles and continue until the cancer progresses or other criteria require stopping treatment. During the study, participants undergo regular assessments to monitor disease status, including imaging scans reviewed by independent experts. Researchers measure progression-free survival and overall survival over periods up to several years. Additional outcomes include response rates, duration of response, quality of life assessments, and side effects. Safety and laboratory evaluations are conducted throughout the study, which spans up to four years and four months in total duration.

Researchers are evaluating the effectiveness and safety of combining calderasib with pembrolizumab as the first treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. The study compares this combination to pembrolizumab with a placebo to see if it improves the time participants live without the cancer worsening and overall survival. Participants receive pembrolizumab through an intravenous infusion every 21 days for up to 35 cycles. They also take calderasib or a matching placebo by mouth daily until they meet criteria to stop treatment. The study is randomized and double-blind, meaning neither participants nor researchers know who receives calderasib or placebo. During the study, participants will have regular assessments to monitor cancer progression, overall survival, response rate, and quality of life measures through questionnaires. Safety will be closely monitored by tracking adverse events and treatment discontinuations. The study may last up to about 56 months, including follow-up to observe long-term outcomes and quality of life changes.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.