Weinheim

PeriPREVENT is a prospective, multi-centre, controlled, open-label, 1:1 randomized superiority trial with two parallel groups. In the intervention group patients will undergo a routine peripheral angiographic intervention (PVI) using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patient's intolerability of CO2 angiography. The control intervention is routine PVI using iodinated contrast media (CM) as standard of care. All patients are followed up until 12 months after the PVI.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are studying the safety and effects of an investigational medicine called PF-08653944 in adults who are overweight or have obesity along with type 2 diabetes. This condition involves carrying too much body weight and having high blood sugar levels. The study is a phase 3, multi-center, randomized placebo-controlled trial that aims to evaluate the medicine's ability to help with weight loss and monitor its safety. Participants will receive either the study medicine or a placebo by weekly injections under the skin in the belly area. About two-thirds of participants will get the study medicine, while one-third will receive the placebo. Participants will be trained to administer the injections themselves at home. The study will last about 21 months and includes up to 14 visits to the study site and 5 phone calls. During the study, participants will be closely monitored through visits and phone contacts. Researchers will measure changes in body weight from the start to week 64 to evaluate effectiveness. The study will also include assessments of safety and treatment effects over the entire duration. Participants need to perform finger-stick glucose monitoring as required and follow the study procedures throughout the trial.

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 evaluating the efficacy and safety of once-weekly injectable MET097 in adults who have obesity or are overweight with related weight complications, but who do not have type 2 diabetes. This phase 3, multi-center randomized controlled trial aims to understand how well MET097 works and how safe it is over a long period. The study will last 84 weeks, with the primary effectiveness measured after 64 weeks of treatment. Participants will receive either MET097 or a placebo, both given once a week by subcutaneous injection. The study compares these two groups to assess the impact of MET097 on weight and related health issues. The treatment period is followed by continued monitoring to evaluate longer-term effects up to 84 weeks. During the study, participants' body weight changes will be carefully tracked from the start through week 64, which is the main outcome measure. Additional health assessments will occur through the 84-week duration to monitor safety and overall responses. Participants will be supported and monitored regularly to assess the medication's impact and any side effects throughout the trial.

Researchers are evaluating the safety and effectiveness of vamifeport in adults diagnosed with hereditary hemochromatosis related to the homeostatic iron regulator gene (HFE-HH). This phase 2, randomized, double-blind, placebo-controlled study aims to assess how vamifeport treatment impacts liver iron levels measured by magnetic resonance imaging (MRI) in these participants. Participants will receive either oral vamifeport capsules or matching placebo capsules during the study. The trial is conducted across multiple centers and uses a parallel-group design. The study specifically examines changes in liver iron concentration over a 360-day period. During the study, participants will undergo MRI scans to measure liver iron concentration at the start and end of the 360-day treatment period. Researchers will monitor safety and collect data on iron overload markers such as transferrin saturation and serum ferritin. The total involvement time for participants includes screening and the one-year treatment and assessment period.

Researchers are evaluating whether adding elacestrant, an oral selective estrogen receptor degrader (SERD), to standard olaparib therapy improves progression-free survival in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have gBRCA1/2 mutations. This phase II, multi-center, randomized, open-label study addresses the urgent need for better treatments in this patient group, who typically have low progression-free survival. Elacestrant has been approved for certain breast cancers resistant to endocrine therapy, and olaparib is an approved PARP inhibitor for gBRCA-mutated metastatic breast cancer. Participants will be randomly assigned in a 2:1 ratio to one of two treatment groups: Arm A receives 600 mg olaparib plus 400 mg elacestrant daily, while Arm B receives 600 mg olaparib daily alone. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or study completion. Blood tests are done at the start of each treatment cycle, and tumor imaging as well as quality of life assessments are conducted every three months or when progression is suspected. During the study, participants will undergo regular blood tests and imaging scans to monitor tumor status and safety. Quality of life questionnaires will also be used to assess patient well-being. Researchers will measure progression-free survival up to 48 months from randomization, defined as time until disease progression or death. The study includes ongoing safety monitoring and follow-up until the end of the study period.

Cholangiocarcinoma is a rare and aggressive bile duct cancer with limited treatment options and a poor outlook. This study investigates the use of ivosidenib, a targeted IDH1 inhibitor, which was approved in May 2023 by the European Medicines Agency for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation, who have already received at least one prior systemic therapy. The study aims to collect real-world data on the effectiveness, safety, and impact on quality of life of ivosidenib treatment. Ivosidenib will be given to patients according to the current prescribing information (SmPC). This is a prospective, multicenter, observational study conducted in Germany, enrolling a broad patient population receiving ivosidenib as part of routine care. Treatment is not assigned by the study but is observed in real-world settings, allowing for the collection of comprehensive data on this therapy. Participants will be monitored for up to 38 months to measure progression-free survival, among other outcomes. Data on quality of life and safety will also be collected. Patients will provide informed consent, and those opting into the patient-reported outcomes module will complete assessments in German. The study will provide valuable insights into how ivosidenib performs outside of clinical trials.

Researchers are investigating treatments for triple-negative breast cancer (TNBC), a type of breast cancer known for its aggressive nature, poor prognosis, and diverse molecular characteristics. This study focuses on patients with early-stage, lower-risk TNBC, particularly those with stage I-II node-negative disease, who generally have better outcomes but still face significant clinical challenges. The trial aims to compare the effects of sacituzumab govitecan alone versus sacituzumab govitecan combined with pembrolizumab in this patient group, seeking to improve treatment responses and survival rates. Participants will receive sacituzumab govitecan at a dose of 10 mg/kg administered twice on days 1 and 8 within a 21-day cycle. Some participants will also receive pembrolizumab at 200 mg every three weeks. The study evaluates treatment durations between 12 and 18 weeks in the neoadjuvant (pre-surgery) setting. The purpose is to assess whether these regimens can produce comparable pathological complete remission rates with a better safety profile compared to standard chemotherapy. The combination with pembrolizumab is explored based on promising results in more advanced TNBC stages. Throughout the study, participants will undergo various assessments including imaging, pathology reviews, and laboratory tests to monitor tumor response and overall health. The primary outcomes measured are pathological complete remission at surgery and invasive disease-free survival rate after three years. Safety and tolerability will also be closely observed. Participants must comply with treatment schedules and follow-ups, providing consent and cooperating with all protocol requirements during the study period.