Springfield

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP). This study is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain. Participants have diabetic peripheral neuropathy mainly affecting their lower limbs and have had this condition for at least six months. The study compares oral LY4065967 to a placebo, with participants randomly assigned to either group. The trial is a Phase 2, randomized, placebo-controlled clinical trial. Treatments are given by mouth, and participants continue their usual diabetes care with stable treatment for at least 90 days before screening. During the study, researchers monitor changes in average pain intensity using a numeric rating scale from baseline to week 8. Participants undergo assessments including blood sugar control (HbA1c), body mass index measurement, and safety monitoring for heart and vitamin B12 status. The trial is designed for adults aged 18 years and older and includes close observation to ensure participant safety throughout the study period.

Researchers are studying a new oral weight loss medicine called MK-4082 in healthy adults who are overweight or obese. This Phase 1 study aims to find a safe dose and understand how the medicine behaves in the body over time. The focus is on whether people tolerate MK-4082 and its safety compared to a placebo. Participants will receive MK-4082 or a placebo in tablet form. The study uses multiple ascending doses to evaluate different levels of the medicine. The goal is to identify a dose that is safe and well tolerated for use in future research. During the study, researchers will monitor participants for any adverse events and whether anyone stops treatment due to side effects. The safety monitoring lasts up to about 98 days for adverse events and 84 days for treatment discontinuation. Participants' health and tolerability of the medication will be closely observed throughout the study period.

Researchers are evaluating enicepatide, a dual GLP-1/GIP receptor agonist, to see how well it works and how safe it is for weight management in adults who are obese or overweight and do not have Type 2 diabetes. The study compares different doses of enicepatide with a placebo to understand its effects. Participants must have a body mass index (BMI) of at least 30, or a BMI between 27 and 30 with at least one weight-related health issue such as prediabetes, hypertension, or sleep apnea. Participants will receive once-weekly injections of either enicepatide or a placebo using an integrated drug-device combination product. The treatment is randomized and double-blinded, meaning neither participants nor researchers know who gets the active medication or placebo during the study. The study is a Phase III trial, and treatments continue over a period leading up to week 72. Throughout the study, participants will be monitored for changes in body weight, with the primary measure being the percent change from baseline to week 72. Safety and efficacy will be assessed regularly, and participants will self-administer the injections or receive help if needed. The study also tracks any side effects and overall health status to understand the long-term effects of enicepatide for weight management.

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 fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants with non-alcoholic fatty liver disease and metabolic syndrome components, aiming to better understand treatment effects in this population. Participants will receive either Efimosfermin Alfa injection or a placebo, with the study designed as a three-arm trial. The treatment will be administered according to the study protocol, though specific dosing details are not provided. The study will monitor participants over a period extending to at least 52 weeks, comparing the safety and tolerability of Efimosfermin Alfa against placebo. During the study, participants will be closely observed through clinical assessments including monitoring for treatment-emergent adverse events (TEAEs), laboratory tests to detect Grade 3 and Grade 4 abnormalities, and evaluation of any adverse events leading to discontinuation of treatment. These safety and tolerability measures will be recorded at Week 52, helping researchers assess the impact of Efimosfermin Alfa over time.

This research aims to learn about the safety and tolerability of a study medicine called MK-1403 in people with type 2 diabetes mellitus (T2D). It also investigates how the body processes MK-1403 over time and its effect on the levels of high-sensitivity C-reactive protein (hsCRP) in the blood. The study is a Phase 1 clinical trial focused on these key aspects in adults with T2D. Participants will receive either MK-1403 combined with an additive coformulation or a placebo combined with the same additive coformulation. Both are given orally. The study includes multiple doses to evaluate the medicine's safety, tolerability, and how it behaves in the body compared to placebo. During the study, researchers will monitor participants for adverse events and any discontinuation related to these events, which will be tracked for up to about 28 days for adverse events and 14 days for discontinuations. Blood tests will measure hsCRP levels and other pharmacokinetic parameters. The trial involves adult participants aged 18 to 75 years with type 2 diabetes, and safety and response to the study drug will be closely followed.

Researchers are evaluating the safety and tolerability of MRT-8102, an experimental oral drug, in healthy adults and in adults at cardiovascular risk with elevated C-reactive protein (CRP). This is the first time MRT-8102 will be given to humans. The study aims to gather safety, tolerability, and pharmacokinetic data to help determine suitable dosing for future research. The study has three parts: In Part 1, healthy participants will receive a single oral dose of MRT-8102 or placebo on Day 1. In Part 2, healthy participants will receive multiple oral doses of MRT-8102 or placebo for 7 consecutive days. In Part 3, participants at cardiovascular risk with elevated CRP will receive daily oral doses of MRT-8102 or placebo for 28 consecutive days. Participants will be monitored for safety and tolerability over different periods: 15 days for the single dose, 21 days for multiple doses in healthy adults, and 56 days for the 28-day dosing in participants at cardiovascular risk. Assessments will include clinical evaluations, laboratory tests, and monitoring for any side effects. The study will also collect pharmacokinetic data to understand how the drug is processed in the body.

Researchers are conducting a prospective, longitudinal, non-interventional, multicenter study to profile molecular biomarkers in patients with head and neck squamous cell carcinoma (HNSCC). The study focuses on individuals with metastatic or unresectable, recurrent HNSCC who are receiving standard of care treatment. The aim is to explore DNA, RNA, immune, and other multiomic biomarkers to better understand prognostic or predictive indicators that could inform future research on relevant biomarkers. Participants will provide tissue and blood samples for molecular biomarker profiling throughout their standard treatment, which involves first line anti-PD1 or PDL1 monotherapy or combination therapy. Tumor tissue samples representative of the current disease must be submitted according to laboratory guidelines. This observational study does not involve any investigational treatments or interventions beyond the participants' usual care. During the study, participants will undergo molecular analyses of their tissue and blood samples over a period of up to 5 years. Researchers will monitor multiomic biomarkers to identify prognostic or predictive factors. The study includes follow-up to collect data that may support the discovery of new biomarkers. Participants must be willing and able to comply with study procedures, including additional blood sample collections.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

This research aims to establish a Phase-2 master protocol framework to evaluate the safety and effectiveness of various investigational treatments for chronic weight management in adults with obesity or overweight. The study sets common entry criteria for participants across multiple specific intervention groups, called intervention-specific appendices (ISAs), which may begin independently as new treatments become available for clinical testing. The overall results will be reported after all ISAs are completed. The study involves multiple investigational drugs administered either by injection (subcutaneously) or orally. These include LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226, and placebo treatments matching the administration methods of the active drugs. Each ISA will detail the specific intervention procedures. Treatments are given according to the ISA schedules as participants are assigned to different groups. Participants will be involved from screening through treatment and monitoring phases, where their body weight stability and other health parameters are assessed. Researchers will track the number of participants allocated to each ISA during the first six weeks. Safety and efficacy will be evaluated throughout the study, which includes regular assessments and adherence monitoring. The study includes adults aged 18 to 75 with specific body mass index (BMI) criteria and weight stability prior to enrollment.