Bayamon

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating the effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the change in hemoglobin A1c (HbA1c) levels in people with type 2 diabetes who have not reached their HbA1c goal despite stable treatment with semaglutide or tirzepatide. This phase 2, double-blind study compares the effects of LY3457263, a drug given by subcutaneous injection, with a placebo in this patient group. Participants will be adults aged 18 to 75 with type 2 diabetes and specific HbA1c and BMI criteria. Participants will receive either LY3457263 or a placebo, both administered once weekly by subcutaneous injection. All participants must be on a stable dose of either injectable semaglutide or tirzepatide for at least three months before the study. The treatment period is 24 weeks, during which researchers will monitor changes in HbA1c levels from the start of the study. Throughout the study, participants will undergo assessments to measure HbA1c at the beginning and at week 24. The total participation duration is about 9 months. Researchers will also track participants' safety and treatment adherence during this time to evaluate the effects of LY3457263 compared to placebo in managing type 2 diabetes.

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

This trial investigates treatments for children aged 2 to less than 12 years with moderate to severe atopic dermatitis, a skin condition causing rash and itching due to inflammation. It compares oral upadacitinib, a drug approved for patients 12 years and older, with subcutaneous dupilumab, focusing on safety, adverse events, and changes in disease activity. The study is phase 3, open-label, and efficacy-assessor-blinded, enrolling about 675 participants worldwide who require systemic anti-inflammatory treatment beyond topical therapies. Participants will be randomly assigned to receive upadacitinib daily as oral tablets or oral solution for 160 weeks, or dupilumab by injection according to its approved dosing every 2 or 4 weeks for 52 weeks. Participants are stratified by disease severity, age, and previous treatment response. After completing treatment, follow-up visits occur for 30 days after upadacitinib and at least 12 weeks after dupilumab. The trial may involve more treatment visits than standard care. Throughout the study, participants attend regular hospital or clinic visits for clinical assessments, blood tests, and questionnaires to monitor disease severity and side effects. Researchers measure the percentage of participants achieving significant improvement in eczema severity by week 16 and track adverse events up to about week 172. This careful monitoring helps evaluate the safety and efficacy of the treatments over the long term.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are investigating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis (RA), a chronic inflammatory disease that causes pain, stiffness, swelling, and loss of joint function. This Phase 2 study includes three substudies that evaluate different treatments for participants who have not responded well to one or two prior biologic or targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies. The study aims to assess both the effectiveness and safety of these therapies. The study tests three treatment approaches: lutikizumab alone, ravagalimab alone, and a combination of lutikizumab and ravagalimab, each compared against placebo. All treatments are given by subcutaneous injection. About 180 participants will be enrolled across approximately 65 sites worldwide. Participants must be on a stable dose of methotrexate to join the study. The study requires regular visits to hospitals or clinics for treatment and monitoring. During the study, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. The main outcomes measured include the percentage of participants achieving a 50% improvement in Rheumatoid Arthritis symptoms by week 12 and the number of participants experiencing adverse events up to about week 22. Participants may have a higher treatment burden than usual care due to the study procedures and visits.