Shavano Park

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are studying the effects and safety of different doses of a new medicine called NNC0662-0419 in people with type 2 diabetes. This study compares NNC0662-0419 with semaglutide, an approved diabetes medication, and a placebo to find out if NNC0662-0419 is an effective and safe treatment option. Participants will be randomly assigned to receive one of these treatments. Participants will receive their assigned treatment by weekly injections under the skin. The study includes groups receiving NNC0662-0419 with increasing doses, semaglutide, or placebo matched to the investigational medicines. Treatments will be given once a week during the study period. During the study, participants will have their blood sugar control monitored by measuring glycated hemoglobin HbA1c at various time points up to 40 weeks. Researchers will also track changes in body weight, blood sugar levels, cholesterol, kidney function, and the number of adverse events. The study lasts until about 48 weeks, allowing for safety and effectiveness assessments throughout this time.

Researchers are evaluating the safety and effectiveness of UBT251, a medicine not yet available for prescription, in adults with type 2 diabetes. This study compares UBT251 with semaglutide, an already approved treatment, and their respective placebos. The goal is to see how well different doses of UBT251 lower blood sugar over time. Participants will be randomly assigned to receive either UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. All treatments are given once weekly by injection under the skin. The study follows participants over several weeks, measuring effects at weeks 16, 28, and 40, focusing on blood sugar control and body weight changes. Throughout the study, participants will have regular assessments including blood tests to measure glycated hemoglobin HbA1c, insulin resistance, beta-cell function, fasting glucose, body measurements, blood pressure, cholesterol levels, and other health markers. Safety is monitored by tracking any adverse events, with total participation lasting up to 40 weeks of treatment plus additional safety follow-up.

This research aims to evaluate how well two new drugs, CagriSema and cagrilintide, help children and adolescents with excess body weight lose weight. The study includes participants aged 8 to under 18 years who have overweight or obesity. It is a Phase 3 trial that compares these new drugs with semaglutide, a drug already prescribed for weight management, and a placebo to understand their effects on weight loss. Participants in the main study are randomly assigned to receive one of four treatments CagriSema, cagrilintide, semaglutide, or placebo. All treatments are given once weekly as subcutaneous injections, starting with a dose escalation phase lasting up to 16 weeks, followed by a maintenance phase for 52 weeks. Those who receive semaglutide do not join the extension study. Participants in the extension study continue treatment with either CagriSema or cagrilintide for up to 156 weeks, while placebo participants follow a specific dosing regimen before continuing in the extension. During the study, participants will be monitored for changes in body mass index BMI and weight over time, with assessments at baseline, week 68, and for some measures, week 224. Researchers will also track body composition, metabolic markers, quality of life, and safety events. The entire duration for participants can be up to nearly five years if they take part in both the main and extension studies, involving regular visits and evaluations to understand the treatments effects and safety.

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 effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

This research aims to evaluate whether participants who previously took donanemab receive clinical benefits from annual doses of the drug. The study focuses on individuals with Alzheimer Disease, Dementia, and Amyloid Plaque accumulation. Sponsored by Eli Lilly and Company, it is a phase 3 trial designed to assess the treatments effects over a long period. Participants are randomly assigned to receive either donanemab or a placebo through intravenous IV administration. The study follows a parallel design with double masking to compare the outcomes between the two groups. The treatment period lasts up to 2.5 years, during which participants will have six visits, including drug administration and monitoring. Throughout the study, participants will undergo evaluations such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Cognitive Function Index CFI, brain amyloid plaque imaging with Florbetapir F 18 PET scans, and plasma tests for phosphorylated tau protein. Pharmacokinetics of donanemab will be measured at baseline, week 52, and week 104. The study involves close monitoring of safety and clinical changes over the entire duration.

Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating LY3457263 compared with a placebo in adults with type 2 diabetes who have not reached their hemoglobin A1c HbA1c goal despite being on stable doses of semaglutide or tirzepatide. This Phase 2, double-blind study focuses on measuring changes in HbA1c levels. Participation in the trial lasts about nine months, aiming to provide insights into treatment effects in this specific patient group. Participants will be randomly assigned to receive one of three doses of LY3457263 or a placebo, all given by subcutaneous injection once weekly. The study uses a parallel-group design where each participant receives only one assigned treatment. The trial compares these treatments over a 24-week period to assess their impact on blood sugar control and body weight. During the study, participants will undergo regular assessments including blood tests to measure HbA1c and fasting serum glucose, as well as body weight measurements. These evaluations occur at baseline and at 24 weeks. The study team will monitor participants health and treatment effects throughout the trial, which is expected to last about nine months in total.