Peoria

Researchers are evaluating aglatimagene besadenovec combined with valacyclovir in men with localized, intermediate-risk prostate cancer who plan to receive external beam radiation therapy EBRT. This phase 2a, open-label, multi-center study aims to assess how the treatment spreads in the body and its effects on immune activation. The study compares this combination therapy plus EBRT to EBRT alone in two groups of participants. Participants in the treatment group will receive three intraprostatic injections of aglatimagene besadenovec, each followed by a 14-day course of oral valacyclovir. EBRT will begin after the second injection. The control group will receive standard or moderately hypofractionated prostate-only EBRT alone. Biospecimens including blood, urine, and semen will be collected at specific times before and after injections or treatments to measure viral presence and immune response. Throughout the study, safety will be monitored continuously by tracking treatment-emergent adverse events and lab results. Researchers will measure the biodistribution of aglatimagene besadenovec up to three months after the last injection. They will also evaluate immune activation biomarkers and tumor-related proteins during this period. Participation includes regular sample collection and clinical assessments, with the total study duration extending up to three months post-treatment.

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 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.

This research aims to evaluate the effects of BGE-102 on blood biomarkers related to inflammation, such as hsCRP, in adults with obesity and cardiovascular risk factors. The study focuses on understanding the safety, tolerability, and pharmacodynamics of BGE-102. It involves participants who are obese with elevated inflammation markers and at least one cardiovascular or metabolic risk factor. Participants will be randomly assigned to receive one of three doses of BGE-102 or a matching placebo. The study drug is taken orally once daily in the morning for 12 weeks. The total study duration is about 20 weeks, including 4 weeks of screening, 12 weeks of treatment, and 4 weeks of post-treatment follow-up. Visits occur every 2 weeks during the first 4 weeks of treatment and every 4 weeks thereafter until week 16. Throughout the study, participants will undergo assessments to monitor inflammation levels, safety, and tolerability. Researchers will measure changes in hsCRP as a primary outcome and track any adverse events. Participants will have regular visits for lab tests, vital signs, and questionnaires. The study also includes follow-up after treatment to monitor ongoing safety and effects, with total participation lasting approximately 5 months.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are studying an investigational drug called ALN-HSD in adults with Metabolic Dysfunction-Associated SteatoHepatitis MASH, a liver condition caused by fat buildup that damages liver cells and causes inflammation and scarring. This condition can worsen to cirrhosis and liver failure. The study aims to evaluate how ALN-HSD affects liver scarring related to MASH and to understand its impact on liver function and inflammation, as well as potential side effects and how the drug is processed in the body. Participants will be randomly assigned to receive either ALN-HSD or a placebo in a double-blind setup. The study involves a 52-week treatment period during which the effects of ALN-HSD on liver fibrosis and other liver-related biomarkers will be assessed. The trial includes genetic risk factor screening for enrollment and collects data on drug levels and metabolites. Treatment is administered according to the study protocol, with monitoring continuing through week 84 for adverse events. Throughout the study, participants will undergo liver biopsies and various laboratory tests to measure liver fibrosis, enzyme levels, and other biomarkers related to MASH. Researchers will track changes from baseline to week 52 in liver fibrosis and inflammation, along with monitoring adverse events until week 84. Participants are involved in regular assessments to evaluate the study drugs impact on their liver health over the course of the trial.

Researchers are evaluating the safety, tolerability, and effectiveness of a one-time intravitreal injection of SAR446597 in people with Geographic Atrophy GA caused by Age-related Macular Degeneration AMD. This sequential Phase 12 study includes two parts and will take place at multiple centers. The study aims to learn how well this treatment works and how safe it is for participants with this eye condition. Participants will receive a single intravitreal injection of SAR446597, with different dose levels tested across successive groups in Part I. In Part II, participants may receive SAR446597 at one of two dose levels or a sham injection as a control. The core study phase lasts about 2 years per participant, followed by an additional 3-year Extended Follow-Up phase to monitor long-term effects. Throughout the study, participants will undergo regular assessments including eye exams to measure changes in the size of GA lesions and visual acuity using standardized charts. Safety will be monitored closely by tracking any treatment-related adverse events. The total participation time spans approximately 5 years, allowing researchers to evaluate both short- and long-term outcomes of SAR446597 treatment.