Ludwigsburg

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating the feasibility and safety of using the EndoTEM system during the endoscopic removal of polyps in the distal colon. The study focuses on whether this new platform allows for complete removal of adenomas or early carcinomas larger than 2 cm located in the rectum or distal sigmoid colon. The trial aims to answer if the EndoTEM system is both practical and safe for this specific procedure. The EndoTEM system is a flexible device introduced through the anus that enables insertion of a second instrument alongside the flexible endoscope. This includes a specially designed curved rigid grasping instrument with a rotatable and angulatable 2 cm tip. Participants will undergo endoscopic submucosal dissection using this system, following standard clinical procedures before, during, and after polyp removal. During the study, participants will complete questionnaires about fecal continence and quality of life before and after the procedure. Researchers will monitor the technical success of the endoscopic resection from the procedure until a follow-up endoscopy conducted six months later. The study includes safety monitoring and evaluation of patient outcomes throughout this period.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are investigating the safety and effectiveness of minimally invasive radical hysterectomy compared to the traditional abdominal radical hysterectomy in patients with early-stage cervical cancer. This trial aims to prove that the less invasive laparoscopic or robotic surgery is not worse than the abdominal approach. For patients meeting specific low-risk criteria (SHAPE criteria), a simple hysterectomy may be performed using either minimally invasive or abdominal methods. The main goal is to measure disease-free survival, with additional evaluations of overall survival, recurrence rates, quality of life, and complications. Patients will be randomly assigned to one of two groups: one undergoing standard abdominal radical or simple hysterectomy, and the other receiving laparoscopic or robot-assisted radical or simple hysterectomy. Both groups may have removal or preservation of ovaries with or without transposition, and pelvic lymph node dissection or sentinel lymph node biopsy according to guidelines. Protective surgical measures are required in the minimally invasive group to reduce cancer cell spread. The trial plans to enroll 756 patients over 4 years, with surgery followed by at least 5 years of follow-up. Participants will undergo surgery according to their assigned group and be monitored regularly to assess disease status and complications. Researchers will collect data on survival without disease recurrence for up to 5 years, along with other health outcomes and quality of life. Safety assessments will continue for one year after surgery, ensuring comprehensive monitoring of any adverse events or treatment effects over time.

Researchers are evaluating the effectiveness and safety of combining perioperative FLOT chemotherapy with intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III gastroesophageal junction (GEJ). This phase III, multicenter, randomized, controlled, open-label study focuses on patients who have received neoadjuvant FLOT therapy and have no distant metastases. All participants receive 3 to 6 preoperative cycles of biweekly FLOT chemotherapy consisting of docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil. After tumor assessment and confirmation of no disease progression, patients are randomly assigned to either receive postoperative FLOT chemotherapy alone (Arm A) or postoperative FLOT combined with intraoperative HIPEC using cisplatin heated to 42°C for 90 minutes during surgery (Arm B). Surgery, typically gastrectomy or transhiatal extended gastrectomy, is planned 4 to 6 weeks after the last FLOT dose, followed by four more 2-week cycles of postoperative FLOT chemotherapy starting 6 to 8 weeks after surgery. Participants undergo tumor assessments using CT or MRI scans before surgery and then every 3 months afterward until disease progression, relapse, death, or study follow-up ends. Clinical visits with blood tests and toxicity monitoring occur before every treatment dose. Safety is closely monitored through adverse event reporting. An initial safety run-in phase evaluates the feasibility and tolerability of the HIPEC procedure after 20 patients have undergone surgery with HIPEC before full study enrollment continues. The primary outcome is the comparison of progression- and disease-free survival between treatment groups over up to 5 years following randomization.

Researchers are investigating treatments for patients with cirrhosis who develop hepatorenal syndrome-acute kidney injury (HRS-AKI), a serious condition with poor prognosis. This study compares the safety and effectiveness of a procedure called transjugular intrahepatic portosystemic shunt (TIPS) against the current standard drug therapy using terlipressin and albumin. The trial includes patients with different stages (1, 2, and 3) of HRS-AKI and aims to evaluate survival outcomes over time. Participants will be randomly assigned to receive either the TIPS procedure along with standard care or standard care alone. TIPS involves placing a shunt in the liver to reduce high pressure in the portal vein, which contributes to HRS-AKI. The standard care group will receive terlipressin and albumin infusions, with noradrenaline as an alternative if terlipressin cannot be tolerated. This multicenter trial follows patients for a minimum of 12 months to monitor their progress and compare treatment results. During the study, participants will undergo regular assessments including clinical evaluations and monitoring of kidney and liver function. Researchers will track survival without the need for liver transplantation over the 12-month follow-up. Safety and any treatment-related complications will also be closely observed. The study aims to provide clearer evidence on whether adding TIPS to standard drug therapy improves outcomes for patients with HRS-AKI and cirrhosis.

Researchers are evaluating the effectiveness and safety of combining carboplatin, paclitaxel, bevacizumab, and niraparib compared to carboplatin and paclitaxel followed by niraparib alone in women newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase III international, multicenter, randomized open trial focuses on patients with specific advanced stages of these cancers who have undergone or plan to undergo surgery and chemotherapy. The study aims to see if adding bevacizumab to the treatment improves progression free survival. All participants first receive one cycle of chemotherapy with carboplatin and paclitaxel. Based on tumor BRCA testing, patients are then randomly assigned to one of two groups: one group receives five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years; the other group receives the same chemotherapy combined with bevacizumab, continuing bevacizumab for up to one year and niraparib daily for up to three years. Treatment schedules follow a three-week cycle. Participants will be closely monitored throughout the trial with frequent assessments to track progression free survival until either 586 events occur or three years after the last patient joins, whichever happens first. The study includes detailed safety evaluations, laboratory tests, and patient questionnaires. To participate, women must meet specific health criteria, including performance status and organ function, and agree to follow study procedures for up to three years of treatment and observation.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.