Clinton

Researchers are evaluating the effects of brenipatide, given alongside standard care, compared to a placebo with standard care, in adults with bipolar disorder. This phase 2 study aims to assess how well brenipatide delays the worsening of bipolar symptoms and monitors its safety. The trial is sponsored by Eli Lilly and Company and includes adults aged 18 to 75 with bipolar disorder type I or II. Participants will be randomly assigned to one of three groups: two different doses of brenipatide or a placebo, all administered by subcutaneous injection along with their usual bipolar disorder treatment. The study consists of three periods: a screening period of about one month, a treatment period lasting at least six months, and a follow-up period of approximately two months. Treatment adherence and symptom changes will be closely monitored during these times. During the trial, participants will self-inject the study medication and keep electronic and paper diaries. Researchers will assess mental health through questionnaires and rating scales, such as the Montgomery-Åsberg Depression Rating Scale and Young Mania Rating Scale, along with quality of life and functional impairment measures. The main outcome is the time until relapse of bipolar symptoms. Safety will be observed throughout, with the total participation duration varying based on individual progress and willingness to continue.

Researchers are studying adult participants with major depressive disorder to evaluate the safety and effectiveness of brenipatide compared to a placebo, both given alongside standard of care treatment. The goal is to see if brenipatide can delay the return of major depressive symptoms. This phase 3, randomized, double-blind trial is sponsored by Eli Lilly and Company and focuses on measuring the time until relapse occurs. The trial includes three main periods: a screening period lasting about one month, a treatment period lasting at least 12 months, and a follow-up period of about two months. Participants receive either one of three doses of brenipatide or a placebo, all administered by subcutaneous injection alongside their usual care. The study may be shortened if depressive symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study drug, maintain diaries, and complete questionnaires throughout the study. Researchers will monitor relapse timing, changes in depression severity, anxiety, functioning, body weight, and quality of life using various scales over at least six months. Safety will be closely observed, including tracking any immune response to the drug. Total involvement may vary depending on symptom changes or withdrawal.

Researchers are evaluating brenipatide, compared to a placebo, in adults with moderate-to-severe Alcohol Use Disorder (AUD). This study aims to assess how brenipatide affects drinking patterns and its safety over a period of approximately 56 weeks. The trial is a phase 3, multicenter, randomized, double-blind study sponsored by Eli Lilly and Company. Participants will receive escalating doses of brenipatide or placebo, administered by subcutaneous injection. The study includes multiple experimental periods where participants receive the study drug or placebo under controlled conditions. The dosing is carefully monitored to assess the drug's effects compared to placebo. During the study, participants will undergo regular assessments including drinking behavior tracked by the Timeline Followback Method, craving levels measured by the Penn Alcohol Craving Scale, and health outcomes collected through questionnaires. Safety will be monitored by evaluating laboratory tests and adverse events. The total participation lasts up to 56 weeks with ongoing monitoring throughout this period.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes accompanied by symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of atogepant compared to a placebo in preventing chronic migraine in participants aged 12 to 17 years. Atogepant is already approved for adults and is now being studied for younger patients to understand its impact on this age group. Participants will be randomly assigned to receive either atogepant or a placebo, both given as oral tablets once daily for 12 weeks. The study is designed to be double-blind, so neither the participants nor the doctors will know who receives the active medicine or the placebo. After the 12-week treatment period, participants will be followed for an additional 4 weeks for further observation. During the study, participants will attend regular visits at a hospital or clinic where they will complete daily diaries, undergo medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure the number of participants experiencing adverse events and changes in monthly migraine days, among other outcomes. The total participation time, including treatment and follow-up, will be approximately 16 weeks.

Researchers are evaluating the drug seltorexant compared with placebo to see how well it improves depressive symptoms in adults and elderly participants diagnosed with major depressive disorder (MDD), a common mood disorder causing lasting sadness and loss of interest. The study also aims to assess the long-term safety and tolerability of seltorexant in participants during an open-label treatment phase. Participants will be randomly assigned to receive either seltorexant or a matching placebo tablet once daily for 42 days in the double-blind treatment phase. Those who qualify for the open-label phase will then receive seltorexant daily for up to 6 months. The study includes both a double-blind phase and an extended open-label phase to monitor treatment effects and safety over time. During the study, participants will undergo assessments including depression rating scales, safety monitoring for adverse events, vital signs, suicidality evaluations, withdrawal symptom checks, and measurements of sexual function, body weight, body mass index, waist circumference, and laboratory tests. The primary outcome focuses on changes in depression severity, while the open-label phase tracks safety and tolerability. Participation may last up to six months depending on the study phase and individual progress.

Researchers are evaluating atogepant, a medicine approved for adults, to study its safety and how well it works in children and teens aged 6 to 17 with episodic migraine. Episodic migraine involves moderate to severe headaches on one side of the head, often with symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This Phase 3, randomized, double-blind study aims to fill the gap in approved treatments for pediatric migraine sufferers. Participants aged 6 to 17 will be divided into groups receiving either a placebo, low-dose atogepant, or high-dose atogepant tablets once daily for 12 weeks. Children aged 6 to 11 will first be part of a pharmacokinetic substudy to determine the appropriate doses. After the 12-week treatment, participants will either have a follow-up visit 4 weeks later or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics, where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in the number of migraine and headache days, adverse events, medication use, and quality of life scores. Safety and effectiveness will be monitored throughout the study, which is expected to continue until May 2028.

Researchers are evaluating the safety and effectiveness of ibuzatrelvir, an oral medication, in adults and adolescents aged 12 and older who have COVID-19 but do not require hospitalization. The study focuses on participants who are at high risk of their illness becoming severe. This phase 3, double-blind trial randomly assigns eligible participants to receive either ibuzatrelvir or a placebo to compare outcomes while allowing standard care treatments. Participants will take ibuzatrelvir or a matching placebo orally every 12 hours for a total of 5 days. The study includes two groups: one receiving the active drug and the other receiving placebo tablets following the same schedule. The total participation period lasts about 6 months, during which researchers monitor health outcomes and adverse events. During the study, participants attend visits where their symptoms, viral loads from nasal or nasopharyngeal swabs, and medical events such as hospitalizations or emergency visits are assessed from the start through 24 weeks. The main outcome measured is the proportion of participants experiencing emergency department visits, hospitalizations, or death related to COVID-19 through 28 days. Safety is monitored continuously and symptom resolution and viral rebound are also tracked.

Researchers are studying the effects and safety of orforglipron, taken once daily, in adults with Fontaine II peripheral arterial disease (PAD) who experience symptoms like intermittent claudication. This Phase 3 trial aims to evaluate how orforglipron influences walking ability and quality of life in participants with this condition. The study is sponsored by Eli Lilly and Company and will last about 58 weeks for each participant. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken orally once daily. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Key assessments will occur at the start and at week 52, measuring walking distance and other health indicators. The trial includes careful monitoring of safety and effectiveness during the treatment period. During the study, participants will undergo tests like the maximum walking distance and pain-free walking distance assessments, quality of life questionnaires, a 6-minute walk test, and blood tests including high-sensitivity C-reactive protein and blood pressure measurements. These evaluations help researchers understand the impact of the drug on PAD symptoms. Participants’ progress and safety will be followed closely throughout the nearly one-year study period.

Researchers are conducting an international, multicenter observational study to better understand subpopulations of patients with Autism Spectrum Disorder (ASD). The study aims to identify sufficient biological and clinical markers that can help distinguish groups of patients who may respond best to specific medications. This research is sponsored by Stalicla SA and focuses on participants aged 12 to 65 years with a prior ASD diagnosis. This study does not involve any specific treatment but collects detailed clinical and molecular data from participants. Participants provide information through their health records and input from parents or reliable caregivers. The study characterizes ASD subpopulations based on clinical and molecular markers gathered at the start of the study. Participants will be involved in providing health history and molecular data on day 0 of the study. Researchers will analyze this information to define ASD subgroups. There are no interventional treatments, and safety monitoring involves excluding participants with recent fever or medical conditions that might interfere with study completion. The study runs until May 2027, allowing comprehensive data collection and analysis over time.

Researchers are evaluating experimental drugs called REGN7508 and REGN9933 for people with atrial fibrillation, a condition where the heart beats too fast and unevenly. The study aims to compare these new drugs with apixaban, a medicine already used to prevent blood clots in atrial fibrillation patients. The research also looks at side effects, how well the drugs reduce stroke risk, drug levels in the blood, and whether the body produces antibodies that might affect the drugs' action. Participants will be randomly assigned to receive either REGN7508, REGN9933, or apixaban according to the study plan. The drugs are given as described in the study protocol. This is a Phase 2, open-label trial with blinded endpoints, which means patients and doctors know the treatment but outcome assessments are blinded. The main treatment period lasts 12 weeks. During the study, participants will be monitored for bleeding events and other side effects up to about 25 weeks. Researchers will measure bleeding rates, stroke or embolism occurrences, drug concentrations in blood, antibody formation, and changes in blood clotting tests. Participants will have regular visits and tests to track safety and treatment effects throughout the trial.