Topeka

Researchers are studying a medicine called enlicitide to lower low-density lipoprotein cholesterol LDL-C in people with high cholesterol. This trial aims to learn if enlicitide given with rosuvastatin, a standard cholesterol-lowering treatment, works better than a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the combinations effect on LDL-C levels in adults with hyperlipidemia. Participants will be assigned to one of four groups enlicitide with a placebo matching rosuvastatin, enlicitide with rosuvastatin, rosuvastatin with a placebo matching enlicitide, or placebos for both drugs. All treatments are taken orally once daily for up to 12 weeks. This setup helps researchers compare the effects of enlicitide alone, rosuvastatin alone, their combination, and placebo. During the study, participants will have their LDL-C levels measured at baseline and at weeks 8 and 12. Researchers will also monitor apolipoprotein B, non-high-density lipoprotein cholesterol, lipoproteina, and adverse events. The main outcome is the percent change in LDL-C at week 8. Safety and tolerability are assessed throughout the treatment and up to about 20 weeks. The total participation duration is up to 12 weeks of treatment with follow-up monitoring.

Researchers are evaluating a new vaccine called V118C designed to help prevent pneumococcal disease, an infection caused by Streptococcus pneumoniae bacteria. This clinical trial focuses on infants and toddlers to assess how safe and well-tolerated V118C is in young children. The study is a Phase 1, randomized, double-blind trial comparing V118C with an existing vaccine called PCV20. The study is divided into two stages. Stage 1 involves toddlers aged 12 to 15 months who have already received a primary series of three doses of PCV vaccine they will receive a single dose of either V118C or PCV20. Stage 2 includes infants starting at approximately 2 months old who will receive four doses three infant doses plus one toddler dose of either V118C or PCV20. All doses are given as 0.5 mL intramuscular injections. Participants will be monitored closely for adverse events immediately after vaccination, as well as for up to 12 months postvaccination. Researchers will collect blood samples to measure immune responses to the vaccines. They will track both injection site and systemic reactions, serious adverse events, and medically attended events. The study aims to understand both safety and immune response profiles of V118C compared to PCV20 over the course of the dosing schedules and follow-up periods.

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis MASH with liver fibrosis at stages F2 or F3. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how this drug affects participants with this liver condition related to metabolic syndrome components. Participants will be randomly assigned to one of three groups one receiving Efimosfermin Alfa at dose level 1, another receiving Efimosfermin Alfa at dose level 2, and a third group receiving a placebo. The study will monitor the effects of these treatments over a period of 52 weeks, assessing safety and tolerability as well as changes in liver fibrosis markers and other related health measures. During the trial, participants will undergo regular assessments including laboratory tests, imaging scans such as MRI and elastography to measure liver stiffness and fat content, and blood tests to monitor liver enzymes and metabolic markers. Researchers will track treatment-emergent adverse events and laboratory abnormalities. The study involves continuous monitoring up to week 52 to evaluate changes from baseline and to ensure participant safety throughout the trial.

Researchers are evaluating new treatments for adults with moderately to severely active ulcerative colitis or Crohns disease through a master protocol called IIBD. This protocol supports multiple individual sub-studies with shared design features, aiming to assess the effectiveness and safety of these treatments over at least 62 weeks. Participants are assigned to the appropriate study before being randomly placed into treatment groups. The study includes two main treatment periods. In one group, participants receive mirikizumab intravenously during the first period, and responders then receive mirikizumab subcutaneously in the second period. Another group receives a combination of oral LY4395089 and intravenous mirikizumab initially, with responders later stopping LY4395089 and continuing with mirikizumab subcutaneously. These treatments are being compared to understand their effects better. Participants will undergo assessments including clinical evaluations, endoscopic examinations, and laboratory tests to confirm disease activity and monitor response. The primary measurement is the number of participants allocated to each treatment appendix during the first 42 days. The study also tracks safety and treatment response over the course of at least 62 weeks, with ongoing evaluations to gather comprehensive data on these interventions.

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 conducting a Phase 2 clinical trial to evaluate the safety and effectiveness of several investigational treatments for chronic weight management in adults with obesity or overweight. This master protocol study includes multiple intervention-specific appendices ISAs that allow for independent assessment of each treatment as they become available. The study aims to establish entry criteria and report results after all ISAs are completed. Participants will be randomly assigned to receive one of several treatments or a placebo. These treatments include LY3305677, LY3841136, tirzepatide, LY3549492, LY3532226, macupatide, and eloralintide, administered either by subcutaneous injection or orally, depending on the specific ISA. Each ISA provides detailed analysis of its respective intervention. During the study, participants will be monitored from baseline through week 6 to assess how many are allocated to each ISA. The trial uses a double-blind design to ensure unbiased results. Participants will be assessed regularly throughout their involvement, which lasts until the completion of all ISAs. Safety and efficacy data will be collected and analyzed throughout the trial.

Researchers are evaluating the safety and effectiveness of efimosfermin alfa in people with metabolic dysfunction-associated steatohepatitis MASH who have biopsy-confirmed liver fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare efimosfermin alfa to placebo in improving liver-related outcomes and resolving steatohepatitis over a long-term period. Participants will be randomly assigned to one of three groups two different dose levels of efimosfermin alfa or a placebo group. The study treatment will be administered under medical supervision, and the trial includes multiple assessments at baseline, Week 52, and Month 48. The study will measure liver fibrosis improvement, steatohepatitis resolution, and liver-related clinical outcomes, among other key health indicators. During the study, participants will undergo liver biopsies, blood tests, imaging scans, and questionnaires to monitor liver health and treatment effects. Researchers will track clinical outcomes for up to 48 months from the start of treatment. Safety will be closely monitored through adverse event reporting and laboratory tests. Participants are expected to attend regular visits for evaluations and follow-up throughout the study duration.

Researchers are evaluating the effectiveness, safety, and tolerability of oral icotrokinra in treating adults and adolescents with moderately to severely active ulcerative colitis UC, a chronic condition where the large intestine lining becomes inflamed and develops ulcers. This Phase 3 clinical trial aims to compare icotrokinra with a placebo to better understand its impact on UC symptoms and remission rates. Participants will be divided into study groups receiving either icotrokinra or a placebo orally each day starting from Week 0 of the induction phase. After 12 weeks, responses will be assessed and participants who respond to icotrokinra or placebo enter a maintenance phase lasting up to Week 40. Adolescents receive open-label icotrokinra throughout the study, with an option for a long-term extension after completing the maintenance phase. During the trial, participants will undergo regular evaluations including clinical response, endoscopic assessments, and symptom monitoring at key points such as Weeks 12 and 40. Researchers will track remission rates, symptom improvements, quality of life, and safety outcomes. The study involves both double-blind and open-label phases and continues until January 2032, with close monitoring to understand how participants respond over time.

Researchers are evaluating the effects of CagriSema, cagrilintide, and semaglutide on weight loss in children and adolescents with excess body weight. This phase 3 study aims to compare these treatments against a placebo to see how well they help manage overweight or obesity in this younger population. The study is sponsored by Novo Nordisk AS and involves participants aged 8 to under 18 years who meet specific BMI and health criteria. Participants are randomly assigned to receive one of four treatments CagriSema a combination of cagrilintide and semaglutide, cagrilintide alone, semaglutide alone, or a placebo. All treatments are given as once-weekly injections under the skin, starting with a dose escalation period of up to 16 weeks, followed by maintenance dosing for 52 weeks in the main study. Those in the extension study continue with CagriSema or cagrilintide for up to 156 weeks, while participants who received semaglutide do not enter the extension phase. During the study, participants will have their body mass index BMI and body weight monitored regularly, with the primary outcome measured as the relative change in BMI from the start to week 68. Additional assessments include changes in body composition through scans like DXA and MRI, metabolic markers, blood pressure, and quality of life questionnaires. Safety is closely monitored throughout, with the total participation lasting about 1 year and 6 months for the main study and up to nearly 5 years if including the extension phase.