Lake Forest

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

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 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 long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are evaluating the safety and tolerability of single and multiple intravenous doses of GIGA-2339 in adults with chronic Hepatitis B Virus HBV infection. This Phase 1 randomized, double-blind, placebo-controlled study aims to understand how the drug behaves in the body and monitor any treatment-related side effects in participants who have been living with HBV for at least six months. Participants will receive either a single intravenous infusion of GIGA-2339 or a placebo in increasing doses on the first day. Following this, participants will receive multiple intravenous infusions of the drug or placebo once every four weeks at the dose determined during the single-dose phase. The study includes two parts Part 1 for single ascending doses and Part 2 for multiple ascending doses, both designed to assess safety, tolerability, and how the drug is processed in the body over time. During the study, participants will undergo regular evaluations including blood tests to measure drug concentration and monitor liver function, safety assessments for any adverse events, and other laboratory tests over periods up to 105 days for single doses and up to 245 days for multiple doses. Researchers will track treatment-emergent adverse events, serious adverse events, and detailed pharmacokinetic data to understand the drugs behavior. Participation may last several months, with visits scheduled according to dosing and monitoring needs.

Researchers are investigating the effects of ALN-AGT01 RVR in adults with mild to moderate hypertension who have previously been treated with zilebesiran. The study aims to evaluate how well ALN-AGT01 RVR works, how it affects the body pharmacodynamics, and its safety. This is a Phase 2 study involving participants aged 18 to 75 years who have specific blood pressure ranges and treatment histories. The trial has two parts Part A focuses on a single dose of ALN-AGT01 RVR in adults with mild to moderate hypertension, while Part B also involves a single dose but includes participants who have discontinued most antihypertensive medications except certain types. Participants receive a single dose of zilebesiran followed by either ALN-AGT01 RVR or placebo, both administered under the skin subcutaneously. Participants will be monitored for changes in blood pressure and serum angiotensinogen levels at several time points, including up to seven days after dosing. Safety is assessed by tracking adverse events for up to 10 months. The study includes blood pressure measurements and laboratory tests to evaluate kidney function and potassium levels. The total duration of participation varies, with primary outcomes measured within the first week and longer safety follow-up extending several months.

Researchers are evaluating how moderate or severe liver impairment affects the levels of inavolisib, a drug given as a single oral dose, in the body. The study focuses on participants with different degrees of hepatic impairment compared to healthy individuals with normal liver function. This phase 1 open-label study aims to understand the drugs pharmacokinetics, safety, and tolerability in these groups. Participants are divided into three groups based on their liver function healthy participants with normal hepatic function, those with moderate hepatic impairment, and those with severe hepatic impairment. Each participant receives one single oral dose of inavolisib on Day 1. The study uses a parallel design where each group is studied separately but concurrently. During the study, participants will have blood samples taken at multiple time points up to 96 hours after dosing to measure drug concentrations and pharmacokinetic parameters such as maximum concentration and area under the curve. Safety is monitored through reported adverse events up to Day 8. The total participation duration includes dosing and follow-up assessments to evaluate the drugs behavior and safety in participants with varying liver function.

Researchers are studying the effects of different levels of liver impairment on how the body processes treprostinil palmitil and treprostinil after a single dose of 80 micrograms of Treprostinil Palmitil Inhalation Powder TPIP. This Phase 1 trial aims to compare people with normal liver function to those with mild, moderate, or severe hepatic impairment to understand the drugs pharmacokinetics. Participants are divided into four groups based on liver function normal, mild, moderate, and severe impairment. Each participant receives one dose of TPIP by oral inhalation using a dry powder inhaler device on Day 1. The study monitors drug levels and safety after this single dose, with no placebo or randomization involved. During the study, participants undergo blood sampling at multiple timepoints up to three days after dosing to measure drug concentration and metabolism. Researchers also track adverse events up to seven days after dosing. Participants are assessed for eligibility with health evaluations and laboratory tests before receiving the dose. The total participation time includes screening, dosing, and follow-up assessments.

Researchers are studying an investigational vaccine designed to protect healthy adults against Escherichia coli E coli. This Phase 1 clinical trial aims primarily to assess the safety and tolerability of several candidate E coli vaccines administered intramuscularly. The study involves healthy adults aged 18 to 64 years without serious medical conditions. Participants will be randomly assigned to receive one of several experimental E coli vaccine doses or a placebo. Each participant receives injections on day 1 and day 180, following a 0 and 6-month schedule. The study is double-blinded, meaning neither the participants nor the investigators know who receives the vaccine or placebo during the trial. During the study, participants will be monitored closely for local and systemic reactions within 7 days after each vaccination. Researchers will also track adverse events from the first vaccination through 12 months after the last dose. Safety assessments include medical exams and recording any serious or medically attended health issues. The total participation lasts up to 18 months with regular visits and safety follow-up.

This research aims to learn about the safety and effects of the study medicine PF-07328948 for adults with heart failure. The study evaluates whether PF-07328948 is safe and effective compared to a placebo in people who already take standard heart failure medicines including SGLT2 inhibitors. It is a phase 2 randomized, double-blind, placebo-controlled trial sponsored by Pfizer. Participants will take either placebo tablets or one of three doses of PF-07328948 tablets once daily by mouth for 36 weeks. The study includes four groups placebo, low dose, medium dose, and high dose of PF-07328948. Treatment lasts 36 weeks, followed by monitoring and assessments. Participants will be involved for about 48 weeks with 15 visits to the study clinic, of which 5 may be performed at home by phone and 10 in person. Researchers will assess clinical events, 6-minute walk test distance, and heart failure symptom scores at baseline and week 36. Safety will be monitored through adverse event reporting up to week 40. Various questionnaires and physical tests will track health status and treatment effects throughout the study.