Olney

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with pembrolizumab can treat triple-negative breast cancer (TNBC). This phase 3 study compares these treatments to chemotherapy chosen by the physician, aiming to see if participants live longer or have longer periods without cancer growth or spread. The study focuses on people with previously untreated locally recurrent unresectable or metastatic TNBC with low PD-L1 expression. Participants receive sacituzumab tirumotecan through intravenous infusion alone or with pembrolizumab, also given intravenously. The study compares these to treatment options including paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin. Pre-medications like antihistamines, acetaminophen, and steroids are given before sacituzumab tirumotecan infusions to help reduce side effects. The trial evaluates safety and effectiveness over several months. Throughout the study, researchers monitor participants up to about 39 months for progression-free survival and up to about 61 months for overall survival. Participants undergo regular assessments to track cancer status and side effects. The study includes careful safety monitoring, and participants must meet specific health criteria to join. The total time in the study and follow-up depends on each participant's response and health status.

Researchers are evaluating the effectiveness, safety, and tolerability of an oral medication called VIM0423 in adults with isolated dystonia, a movement disorder causing sustained muscle contractions and abnormal postures. This Phase 2, randomized, double-blind, placebo-controlled study focuses on individuals with dystonia affecting two or more body regions, aiming to see if VIM0423 improves symptoms, daily function, and quality of life compared to placebo. Currently, treatments are limited, especially for those with multiple affected areas, and VIM0423 targets the underlying chemical imbalance in the brain. Participants will be randomly assigned to receive either VIM0423 or a matching placebo, taking up to six pills once daily before bedtime over 16 weeks. The study includes several phases: screening and baseline (up to 14 weeks with two visits), dose titration and maintenance, dose taper (16 weeks with three visits), followed by a safety follow-up period of two weeks with one final visit. Neither participants nor investigators will know who receives the active drug or placebo unless necessary. Throughout the study, participants will attend six in-person visits and undergo various assessments including clinical lab tests, EKGs, and video recordings to monitor dystonia changes. They will also complete self-assessments about their symptoms and how dystonia affects daily living. Adverse events and safety will be closely observed, with the primary outcome measuring change in dystonia severity from baseline to week 14 using a standardized rating scale. Total participation lasts up to 32 weeks.

Researchers are studying individuals aged 12 to 65 who have isolated (or primary) dystonia affecting more than one area of the body. This observational study aims to collect detailed information about how dystonia impacts daily life, including aspects such as well-being, pain, relationships, and social interactions. The study also seeks to understand how the disease changes over time and to evaluate commonly used clinical scales for measuring dystonia symptoms. The information gathered will help support future clinical research in this patient population. No treatments are given as part of this study since it is observational. Participants will undergo assessments using various clinical rating scales to measure the severity and impact of their dystonia. Researchers will also gather detailed medication histories and note any health events like hospitalizations or new diagnoses during the study period. Participants will be asked to complete assessments over time to track changes in their condition. These include evaluations based on the Burke-Fahn-Marsden Dystonia Rating Scale. The study will monitor disease progression and impact without intervening in the participant's usual care. This process helps researchers better understand the condition and the reliability of clinical scales used for dystonia. The total participation duration depends on the study schedule but involves multiple visits for data collection and observation.

Researchers are evaluating the effects of IGC-AD1, an oral medication containing THC and melatonin, on agitation in people aged 60 and older with mild to severe Alzheimer's dementia. This Phase 2, multi-center, double-blind, randomized, placebo-controlled trial focuses on participants who have shown clinically significant agitation for at least two weeks, confirmed by specific agitation scales and criteria. The study aims to assess the medication's impact on agitation levels and safety. Participants will receive either IGC-AD1 or a placebo oral solution twice daily for 42 days, followed by a two-day tapering period. The study includes daily safety calls in the first days, then calls every third day to monitor participants' condition, medication changes, and any side effects. Blood samples will be collected to analyze drug levels, brain biomarkers, and genetic factors. During the study, caregivers will assist with electronic device use and maintaining logs. Researchers will measure agitation using the Cohen-Mansfield Agitation Inventory over six weeks, with additional assessments at two weeks. The study includes ongoing safety monitoring, medication adherence checks, and follow-ups to evaluate the treatment's effects and participant well-being throughout the trial.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

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, safety, and tolerability of remibrutinib in people living with relapsing multiple sclerosis (RMS). This Phase 3b study compares remibrutinib after switching from ocrelizumab to continuous ocrelizumab treatment. It aims to provide important data on how well remibrutinib works and how safe and tolerable it is for patients with RMS. Participants are randomly assigned to receive either remibrutinib tablets taken daily or ongoing ocrelizumab infusions or injections at standard doses (600mg infusion or 920mg injection). The study includes an initial Core Part lasting up to 24 months, followed by an Extension Part lasting up to 24 months where eligible participants continue open-label treatment with remibrutinib. The study is conducted at multiple centers, including locations in the USA and worldwide. During the study, participants will be monitored regularly with assessments that include brain MRI scans to measure the annualized rate of new or enlarging T2 lesions. Researchers will also evaluate safety and tolerability throughout both study parts. Those completing the Core Part may join the Extension Part to continue receiving remibrutinib for long-term observation. The total study duration for participants can be up to 48 months.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.