Niagara Falls

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the drug orforglipron in people who have obesity or are overweight and also suffer from osteoarthritis OA of the knee with pain. This study aims to assess how well and safely orforglipron works for this group of participants. The trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study sponsored by Eli Lilly and Company. Participation in the study will last about 74 weeks. Participants will be randomly assigned to receive orforglipron or a placebo orally. The study includes two independent groups under a master protocol, each comparing orforglipron to placebo. Treatment is given once daily, and the study design is parallel-arm, meaning participants remain in their assigned group throughout the trial. During the study, participants will undergo various assessments including pain evaluation using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, physical function tests, body weight measurement, health surveys, walking tests, and blood tests for inflammation markers and cholesterol. Safety and drug levels will also be monitored. These evaluations occur from the beginning of the study through week 72, with participant involvement spanning about 74 weeks total.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

This trial evaluates treatments for children aged 2 to under 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib to subcutaneous dupilumab, focusing on changes in disease activity and side effects. The study involves participants who need systemic anti-inflammatory therapy because topical treatments alone are insufficient. The trial is a phase 3, randomized study conducted worldwide with about 675 children. Participants receive either upadacitinib daily as oral tablets or solution for up to 160 weeks, or dupilumab injections every 2 or 4 weeks for 52 weeks, following approved dosing schedules. Some participants are randomized to receive different doses of upadacitinib or dupilumab. Participants are grouped based on disease severity, age, and prior treatment responses. After treatment, there is a follow-up period of at least 30 days for upadacitinib and 12 weeks for dupilumab to monitor safety. During the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers measure outcomes including the percentage of participants achieving significant reductions in eczema severity using specific scales at week 16 and other timepoints, as well as tracking adverse events up to week 172. The study aims to understand treatment safety and effectiveness over a long term.

Researchers are evaluating the safety and effects of the medicine ritlecitinib for adults with chronic spontaneous urticaria CSU that is not well controlled by antihistamines. CSU causes itchy hives and swelling in the skin and fatty tissue without a clear cause. This phase 2 study aims to compare two oral doses of ritlecitinib, 50 mg and 100 mg, against a placebo to learn how well they work and their safety profiles. Participants will be randomly assigned to one of three groups taking 50 mg ritlecitinib, 100 mg ritlecitinib, or a placebo, each taken once daily by mouth for 12 weeks Period A. After this, those on ritlecitinib continue their doses for another 12 weeks Period B, while those initially on placebo switch to 100 mg ritlecitinib for the same duration. Placebo capsules matching the active doses will be given to maintain study blinding. Participants will be involved in the study for about 8 months and will visit the study site up to 9 times. During visits, they will have physical exams, hearing tests, blood tests, chest X-rays, and ECGs. They will also complete daily questionnaires about their symptoms using an electronic diary. The main outcome measured is the change in their urticaria activity score after 12 weeks, along with monitoring for any side effects or adverse events throughout the study.

Researchers are evaluating whether tralokinumab given as subcutaneous injections along with topical corticosteroids TCS is safe and effective for treating moderate-to-severe atopic dermatitis AD in children and infants. The trial involves two age groups children aged 2 to under 12 years and infants aged 6 months to under 2 years. Children are randomized to receive either tralokinumab plus TCS or placebo plus TCS, while infants receive open-label tralokinumab plus TCS. This Phase 3 trial will last up to four years with visits every two weeks during the first year and every six weeks thereafter, including some phone visits.

Researchers are evaluating the safety and effects of NNC0487-0111 in adults with excess body weight and knee osteoarthritis. This study compares the active treatment with a placebo injection given once weekly. The goal is to assess weight loss and pain reduction over a long-term period, as well as other health measures related to osteoarthritis and metabolic health. Participants are randomly assigned to receive one of two dose levels of NNC0487-0111 or a placebo injection, both administered under the skin once a week. These injections are given alongside a reduced-calorie diet and increased physical activity. The treatment period lasts up to 80 weeks, during which participants follow the specified lifestyle changes. Throughout the study, participants will have regular assessments including body weight, knee pain and function scores WOMAC, physical functioning, blood pressure, cholesterol levels, blood sugar control HbA1c and fasting glucose, and use of pain medications. Safety events and adverse reactions are monitored up to week 84. Participants will be followed closely with these measurements to evaluate the treatments impact and overall safety.

Researchers are investigating whether adding ertapenem to cefazolin improves treatment outcomes in adults with methicillin-susceptible Staphylococcus aureus MSSA bacteremia. This phase 2 randomized controlled trial builds on previous laboratory and animal studies, as well as small human case series, suggesting potential benefits of this drug combination. The study is a sub-study of the larger Staphylococcus aureus Network Adaptive Platform SNAP trial and aims to explore clinical success rates by day 5 of treatment. Participants receive either ertapenem 1 gram intravenously once daily infused over 2 hours for 5 days alongside cefazolin or a saline placebo infused daily over 2 hours for 5 days with cefazolin as standard therapy. The study uses quadruple masking to compare the effects of ertapenem plus cefazolin against cefazolin with placebo. The trial will monitor a variety of secondary outcomes including blood culture clearance at 30 days, clinical improvement, length of hospital stay, mortality, and infection complications over periods up to 90 days. Throughout the study, participants will have blood cultures and clinical assessments to evaluate infection clearance and treatment response. Researchers will also monitor for adverse events such as acute kidney injury or seizures within the first week. The total participation timeframe includes outcome assessments up to 90 days after treatment starts. This comprehensive monitoring will help determine if the combination therapy reduces bacteremia duration and improves patient outcomes without increasing risks.

The trial investigates treatments for bloodstream infection caused by Staphylococcus aureus SAB, which can be life-threatening with a 15-30% death rate within three months. This international, multi-center randomized adaptive platform trial aims to find the best treatment options to reduce mortality within 90 days of infection. The trial adapts over time by assigning more patients to treatments that show better outcomes and removing less effective options. Participants receive various antibiotic treatments depending on their group. These include intravenous vancomycin or daptomycin, flucloxacillin or cloxacillin, cefazolin, or benzylpenicillin, with dosages adjusted for kidney function or illness severity. Some receive adjunctive drugs like clindamycin, and others may switch from intravenous to oral antibiotics if eligible after 7 or 14 days. Additionally, some participants undergo PETCT scans as part of the study. During the study, participants are monitored closely with blood cultures, temperature checks, and clinical assessments to track infection clearance and complications. Researchers measure all-cause mortality at 90 days as the primary outcome, along with other outcomes such as survival at earlier time points, hospital stay length, microbiological treatment failure, serious reactions, and antibiotic use. Safety and health economic data are also collected to evaluate treatments comprehensively throughout the trial.