Hamden

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain DPNP, which is pain caused by nerve damage due to diabetes. This trial is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain conditions. The study is a randomized, placebo-controlled Phase 2 clinical trial sponsored by Eli Lilly and Company. Participants in this study will be randomly assigned to receive either LY4065967 or a placebo, both taken by mouth. The treatment period includes regular dosing, and the study compares the effects of the drug against placebo to assess its impact on pain relief. The trial uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the trial, participants will have their pain intensity tracked using the Numeric Rating Scale, along with other assessments such as sleep quality, emotional functioning, and pain interference with daily activities. These evaluations will occur from baseline through week 8 to monitor changes. Researchers will also measure the use of rescue medication and overall patient improvement. Safety monitoring and follow-up will be part of the study to ensure participant well-being throughout the trial duration.

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are conducting a master protocol study to evaluate multiple independent pain treatments for people with chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different interventions within a structured framework that includes specific criteria and unique assessments for each condition. The study is designed as a randomized, placebo-controlled Phase 2 clinical trial to better understand these treatments. Participants are randomly assigned to receive one of several investigational drugs or matching placebos. These drugs include LY3016859, administered intravenously, and LY3556050, LY3526318, and LY3857210, all given orally. The interventions are organized in separate appendices focusing on each pain condition, allowing some to begin independently as they become available for testing. During the study, participants will be monitored from baseline up to 8 weeks to track allocation to each intervention-specific appendix. Researchers will assess pain levels, functional status, and safety through various scales and tests. The study involves maintaining stable non-drug therapies and discontinuing current pain medications except rescue medications. Participants will undergo physical exams, lab tests, and screening for medical history to ensure safety throughout the trial, which is led by Eli Lilly and Company and is expected to continue until April 2027.

Researchers are studying whether the medicine NNC0487-0111 is safe and effective for adults with excess body weight and knee osteoarthritis. The trial focuses on how this treatment may help reduce weight and knee pain compared to a placebo, which contains no active medicine. This is a Phase 3 randomized study sponsored by Novo Nordisk AS.

Researchers are evaluating the efficacy and safety of eloralintide compared with placebo for reducing body weight in adults with overweight or obesity who also have type 2 diabetes. This Phase 3 study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Eli Lilly and Company. The study aims to understand how well eloralintide works for weight loss and its effects on related health measures over a period of about 75 weeks. Participants will be randomly assigned to receive one of four doses of eloralintide or a placebo, all given as weekly subcutaneous injections. The treatment period lasts 64 weeks, during which participants will receive their assigned dose once weekly. The study compares different doses of eloralintide to placebo to assess its impact on body weight and other health outcomes. During the study, participants will undergo regular assessments including body weight, body fat, waist circumference, blood sugar control HbA1c, blood pressure, and various blood markers like triglycerides and insulin. Patient questionnaires will measure physical function and quality of life. Researchers will also monitor medication use and pharmacokinetics of eloralintide. Participation involves about 75 weeks including follow-up, with close monitoring for safety and treatment effects.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis UC. This phase 2 study focuses on how these medications work alone or in combination for people who have had UC for at least three months and have not responded well or tolerated previous treatments. The trial is sponsored by Eli Lilly and Company and aims to improve treatment options for this condition. Participants may receive eltrekibart alone, mirikizumab alone, both drugs together, or placebos in various combinations. The study uses a randomized, double-blind design to compare these different treatment groups. The trial lasts about 69 weeks, including a screening period up to 35 days before enrollment. Treatments are administered throughout the study, with doses adjusted as needed to assess safety and effectiveness. During the trial, participants will undergo regular assessments including clinical remission rates at 12 and 52 weeks, endoscopic and histologic evaluations, and quality of life questionnaires. Blood tests will measure drug levels to monitor pharmacokinetics. Safety and response to treatment will be closely monitored throughout the study, which spans approximately 4 to 5 years in total. Participants will have multiple visits for evaluations to track their progress and any side effects.

Researchers are evaluating the safety and effectiveness of solbinsiran in lowering triglyceride levels and other lipid measures in adults with severe hypertriglyceridemia. This phase 2 study compares solbinsiran to a placebo and aims to better understand how this treatment might help people with this condition. The trial is sponsored by Eli Lilly and Company and focuses on participants with very high fasting triglyceride levels. Participants will be randomly assigned to receive either solbinsiran or a placebo through two subcutaneous injections. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. The main treatment period includes monitoring changes in triglycerides and other lipid markers over 16 to 24 weeks. During the study, participants will have fasting triglyceride levels measured at baseline and during follow-up visits. Researchers will also assess changes in other blood lipids such as ANGPTL3, VLDL cholesterol, and non-HDL cholesterol at 24 weeks. Pharmacokinetic testing will measure how the body processes solbinsiran after dosing. The study runs from December 2025 to August 2027, with safety and efficacy monitored throughout.

Researchers are studying the effects of combining vedolizumab intravenous infusion with either adalimumab or ustekinumab in adults who have moderate to severe Crohns Disease and have not responded adequately to certain previous treatments. The study aims to assess the effectiveness and safety of this dual targeted therapy and then evaluate vedolizumab alone in participants who respond to the combination treatment. This is an open-label Phase 4 study conducted in multiple centers in the United States and Canada, enrolling about 100 participants aged 18 to 70 years. Participants in Part A receive dual targeted therapy one group is treated with vedolizumab IV 300 mg at Weeks 0, 2, 6, and every 8 weeks up to Week 22 combined with adalimumab injections starting at 160 mg and tapering doses until Week 26 another group receives vedolizumab IV on the same schedule combined with weight-based ustekinumab IV followed by subcutaneous doses every 8 weeks until Week 24. Those showing therapeutic benefit by Week 26 enter Part B, receiving vedolizumab IV 300 mg monotherapy every 8 weeks from Week 30 to Week 46. Participants will have regular assessments including endoscopic evaluations using the Simple Endoscopic Score for Crohns Disease SES-CD at Weeks 26 and 52 to measure response. Other outcomes include clinical remission based on the Crohns Disease Activity Index CDAI, patient-reported symptom scores, and safety monitoring throughout the study. After completing treatments, participants will be followed for an additional 20 weeks, resulting in an overall participation time of about 76 weeks.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are evaluating two different monitoring approaches for pancreatic cysts and associated biomarkers to improve risk detection of progression to pancreatic cancer. This observational study aims to compare more frequent versus less frequent monitoring schedules and identify biomarkers from blood tests and imaging that may better predict the development of concerning features or high-risk signs. The study also assesses patient quality of life, financial distress, anxiety, and healthcare costs related to these surveillance programs. Participants undergo magnetic resonance imaging MRI, computed tomography CT, or endoscopic ultrasound EUS scans, as well as blood sample collections throughout the trial. The study originally randomized patients into two surveillance arms a low-intensity group with less frequent imaging and a high-intensity group with more frequent imaging based on cyst size. Patients may also undergo biopsies, fine needle aspiration, and surgery as clinically needed. The study is closed to new accrual but continues follow-up. Participants are followed every 6 to 12 months for up to 5 years after enrollment. Researchers collect imaging results, blood samples, and clinical data to track the development of worrisome cyst features or high-risk stigmata. They also evaluate patient-reported outcomes including quality of life, anxiety, and financial distress. Safety and treatment pathways are documented, and the primary outcome focuses on the time to detecting concerning cyst features on imaging over the 5-year period.