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Researchers are evaluating treatments for non-muscle invasive bladder cancer NMIBC, the most common form of bladder cancer. This phase II clinical trial compares the standard treatment of intravesical Bacille Calmette-Guerin BCG with a combination of BCG and the drug bicalutamide. The study addresses the issue that 30-40% of patients still experience relapse or disease progression despite standard therapy, exploring whether adding bicalutamide may help reduce recurrence rates. The trial includes two groups cohort A, an open-label group of about 40 patients, and cohort B, a double-blind group with placebo involving approximately 120 patients. In both cohorts, participants receive six cycles of intravesical BCG. Cohort A compares BCG alone to BCG plus daily oral bicalutamide 150 mg for 3 months. Cohort B compares BCG plus bicalutamide to BCG plus a daily oral placebo for 3 months. Participants are involved for 36 months from screening to final follow-up. The study monitors bladder tumor recurrence rates over three years as the primary outcome. Secondary outcomes include tumor progression, number of recurrences, quality of life, and urinary symptoms. Safety and treatment effects are assessed regularly during this period to understand the impact of adding bicalutamide to standard BCG therapy.

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are studying ML-007C-MA to assess its safety and effectiveness in treating hallucinations and delusions in adults aged 55 to 90 who have Alzheimers Disease Psychosis ADP. This phase 2 randomized, double-blind, placebo-controlled trial aims to compare ML-007C-MA with a placebo by measuring changes in specific symptoms using the Neuropsychiatric Inventory-Clinician NPI-C Hallucinations and Delusions score. Participants will be randomly assigned to receive either ML-007C-MA at doses of 1051.5 mg or 2103 mg twice daily, or placebo tablets. The treatment period lasts 7 weeks, during which the study will monitor symptom changes and safety. The study includes adults with confirmed ADP and psychotic symptoms who have a designated care partner to help with symptom reporting and medication adherence. Throughout the trial, participants will undergo assessments including the NPI-C Hallucinations and Delusions score, Clinical Global Impressions-Severity CGI-S scale, and Mini-mental State Examination MMSE. These evaluations occur at the start and end of the 7-week treatment to measure symptom changes. Safety monitoring and adherence tracking will be part of the study, which is scheduled to complete by December 2027.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are studying a combination of two experimental drugs, pozelimab and cemdisiran, to find better treatment options for adults with Paroxysmal Nocturnal Hemoglobinuria PNH whose condition has not improved despite current treatments with complement component 5 C5 inhibitors like eculizumab, ravulizumab, or crovalimab. This Phase 3 study aims to evaluate how well the drug combination lowers hemolysis and to monitor potential side effects, drug levels in the blood, and antibody responses against the study drugs. The treatment involves two periods a 28-week initial Treatment Period TP and a 52-week Extension Period EP. Participants receive the pozelimab and cemdisiran combination therapy according to the study protocol during these times. The study is designed as a single-group trial where all participants receive this combination treatment. Participants will be involved in regular clinic or remote visits throughout the study to monitor their health and treatment effects. Assessments include measuring lactate dehydrogenase LDH levels to track hemolysis, monitoring hemoglobin levels, fatigue, and transfusion needs, as well as checking for adverse events and antibody development against the drugs. The study also measures drug concentrations and complement activity. The total participation duration spans up to 80 weeks, including both treatment periods.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.