South Jordan

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating the safety and side effects of LY4005130, a drug given through a vein, in adults with non-segmental vitiligo NSV. This study compares LY4005130 to a placebo to better understand how well the drug is tolerated. The trial is a Phase 2, randomized, double-blind study lasting about 48 weeks, including screening, to provide detailed information on treatment effects. Participants receive either LY4005130 or a placebo intravenously during the 24-week treatment period. Blood tests will be used to see how the drug moves through and affects the body. The study measures changes in vitiligo skin area using scoring indexes and also examines gene expression from skin biopsies. The comparison between the drug and placebo aims to provide clear insights into treatment effects. Throughout the study, participants will have assessments including blood tests and skin biopsies at the start and after treatment. Researchers will track side effects and changes in vitiligo by measuring the affected skin area. The study includes regular evaluations of drug levels in the blood and gene activity related to vitiligo. Participation involves about 48 weeks total, covering screening, treatment, and follow-up to monitor safety and response.

Researchers are evaluating the effects of LY4005130 in adults with severe alopecia areata, a condition causing significant hair loss. This phase 2 study compares LY4005130 with a placebo to see how well the drug works and how well participants tolerate it. Blood tests will be used to understand how the body processes the drug and its effects. Participants will receive either LY4005130 or a placebo, both administered intravenously into a vein. The study follows a randomized, double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The study lasts about 48 weeks, including screening. During the study, participants will undergo regular assessments including blood tests and scalp biopsies to track changes in hair loss severity and gene expression. The main measurement is the percentage of participants reaching a certain improvement in hair loss by week 24. Safety and side effects will be closely monitored throughout the study period.

Researchers are evaluating the effects of orforglipron, taken once daily by mouth, compared to placebo in adolescents aged 12 to 17 years who have obesity or are overweight with related health conditions. The study aims to assess the drugs efficacy, safety, and how it is processed by the body. This phase 3 trial is conducted under a master protocol and sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either orforglipron or a placebo orally once daily. Those who complete the initial PW01 study, including a safety follow-up period, may continue receiving orforglipron for an additional 156 weeks while maintaining lifestyle interventions such as diet and exercise counseling. The trial follows a double-blind design where neither participants nor researchers know the assigned treatment. During the roughly 18-month participation, adolescents will undergo regular assessments including body mass index BMI, body weight, waist circumference, blood pressure, cholesterol, glucose levels, insulin levels, body fat mass via DXA scans, and quality of life related to weight impact. Pharmacokinetic measurements will also be taken to study the drugs concentration over time. Safety and effectiveness will be monitored through these evaluations at baseline and at Week 72.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

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.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years who have nonsegmental vitiligo. The study focuses on pediatric participants with depigmented areas of skin caused by this condition and seeks to better understand how the cream may impact these areas. Participants will be randomly assigned to receive either ruxolitinib 1.5% cream or a matching vehicle cream. Both creams are applied topically as a thin film twice daily to the affected skin areas according to the study protocol. The trial includes a 24-week treatment period during which improvements in skin pigmentation and safety outcomes are monitored. During the study, children will have regular assessments including evaluations of the affected skin areas using the Facial Vitiligo Area Scoring Index and Total Body Vitiligo Area Scoring Index. Safety is monitored through reports of any side effects and laboratory tests at various timepoints up to 52 weeks. Participants are followed closely for adherence to treatment and overall health throughout the study duration.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are investigating how well and safely Eloralintide LY3841136 works in adults who are overweight or obese and suffer from osteoarthritis pain in the knee. This study supports two independent phase 3 trials under a master protocol, focusing on improving knee osteoarthritis symptoms and body weight management in this population. Participants will receive either Eloralintide or a placebo by subcutaneous injection once weekly. The study follows a randomized, double-blind, parallel design with two separate arms for each independent study. Treatment and observation will last approximately 75 weeks, including the screening period. During the study, participants will undergo various assessments including measurements of body weight, knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC pain subscale, blood pressure, physical function, inflammation markers, and metabolic parameters. Researchers will also track medication use, walk test performance, and other health-related quality of life measures over time to evaluate the effects and safety of Eloralintide.