Lake Forest

Researchers are evaluating the safety and effectiveness of enicepatide, a dual GLP-1/GIP receptor agonist, for managing weight in adults with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to understand its impact on weight loss in this population. Participants receive either enicepatide or a placebo once weekly through an integrated drug-device combination. The study uses a randomized, double-blind, placebo-controlled design to assess the effects of the treatment. The placebo is volume-matched and administered using the same method as the active drug. During the study, participants will have their body weight changes measured up to week 72 to assess efficacy. Researchers will monitor weight changes as the primary outcome. Participants must be able to self-administer the injections or receive them from a trained individual, and their safety and adherence will be observed throughout the study period.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the safety and tolerability of AMG 691 in both healthy adults and adults with mild-to-moderate asthma. This Phase 1 study aims to assess how participants respond to single and multiple doses of AMG 691 compared to a placebo. The study includes adults aged 18 to 70 years and focuses on understanding the drug's effects in these populations. Participants receive either AMG 691 or a placebo through subcutaneous injections. The study includes single ascending dose and multiple ascending dose periods to carefully monitor reactions to different dosing levels. Healthy participants receive single or multiple doses, while participants with asthma receive multiple doses. Female participants must be of non-childbearing potential or use effective contraception if of childbearing potential. During the study, participants undergo medical evaluations, lung function tests, blood tests, and monitoring for any treatment-emergent adverse events over approximately 11 months. Researchers track lung function measures such as forced expiratory volume and biomarkers like blood eosinophils and exhaled nitric oxide. Safety and tolerability are closely monitored through regular assessments and questionnaires to evaluate asthma control and overall health.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and tolerability of GIGA-2339, given as single and multiple intravenous doses, in adults with chronic Hepatitis B Virus (HBV) infection. This Phase 1, randomized, double-blind, placebo-controlled study focuses on participants who are HBeAg negative and have stable or no nucleos(t)ide analogue treatment. The study aims to monitor adverse events and pharmacokinetics of GIGA-2339. Participants will receive either GIGA-2339 or placebo by intravenous infusion. The study includes single ascending dose (SAD) and multiple ascending dose (MAD) periods, with safety monitored up to Day 105 for SAD and up to Day 245 for MAD. The dosing schedule and details are arranged to assess how the body processes the drug and how well it is tolerated. During the study, participants will undergo evaluations including laboratory tests, ECGs, liver imaging, and monitoring for treatment-emergent adverse events. Researchers will track drug levels and safety signals throughout the study. Participants are expected to remain on stable antiviral therapy if applicable and use contraception as required. The overall participation timeframe covers the dosing and follow-up periods to ensure thorough safety assessment.

Researchers are evaluating the effectiveness, pharmacodynamics, and safety of ALN-AGT01 RVR in adults with mild to moderate hypertension who have been pretreated with zilebesiran. This Phase 2 study involves participants aged 18 to 75 years with specific blood pressure criteria and prior medication conditions. The study aims to better understand how ALN-AGT01 RVR works and its impact on blood pressure when given as a single dose. The study is conducted in two parts. Part A involves a single dose, dose-ranging phase where adults with mild to moderate hypertension receive ALN-AGT01 RVR or placebo subcutaneously. Part B also involves a single dose given subcutaneously to adults with mild to moderate hypertension following specific medication discontinuation protocols. All participants have been pretreated with zilebesiran, which is also administered subcutaneously. Participants will undergo assessments including measurements of serum angiotensinogen recovery up to Day 4 and blood pressure recovery at Day 4 and Day 7. Blood pressure is measured in a seated office setting. Safety and pharmacodynamic effects are closely monitored throughout the study. The total duration of involvement includes these evaluation periods following the single dose administration.

Researchers are evaluating how moderate or severe liver problems affect the way the body processes a drug called inavolisib. This open-label Phase 1 study compares participants with different levels of liver impairment to healthy individuals with normal liver function. The goal is to understand the drug's safety, how long it stays active in the body, and how well it is tolerated in these groups. Participants will receive a single oral dose of inavolisib. The study includes three groups: healthy participants with normal liver function and those with moderate or severe liver impairment. Researchers will closely monitor the drug levels in the blood at multiple time points up to 96 hours after dosing to study its behavior in the body. During the study, participants will undergo tests to measure drug concentration, liver function, and overall safety. Blood samples will be taken before and at several intervals after taking the drug to track its concentration over time. Participants will also be checked for any side effects or health changes throughout the study.

Researchers are evaluating an investigational vaccine aimed at protecting healthy adults from Escherichia coli (E coli). The main goal is to assess the safety and how well adults tolerate these E coli vaccines when given as shots into the muscle. This is a Phase 1 study focusing on healthy volunteers aged 18 to 64 years. Participants will receive one of several candidate E coli vaccines or a placebo, each given in two doses spaced six months apart (at 0 and 6 months). The study includes different versions and doses of the vaccine, all administered intramuscularly following the same schedule. The placebo group follows the same 0 and 6-month dosing interval for comparison. Throughout the study, participants will be monitored for local and systemic reactions within seven days after each vaccination, as well as any adverse events from the first vaccination until one month after the last dose. Additionally, medically attended and serious adverse events will be tracked for up to 12 months after the final vaccination, with the entire observation period lasting up to 18 months. Safety and tolerability will be carefully evaluated through these measures.

This research aims to evaluate the safety and effects of the study medicine PF-07328948 for adults with heart failure. It focuses on how this medicine works compared to a placebo in people who are already using standard heart failure treatments that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. The trial is a Phase 2 study designed to better understand if PF-07328948 is safe and effective for managing heart failure symptoms and improving patients' health. Participants will be randomly assigned to receive either placebo tablets or one of three doses of PF-07328948 (low, medium, or high dose). All medications are taken once daily by mouth for 36 weeks. The treatment period is followed by ongoing study visits to monitor participants. The study involves 15 visits over about 48 weeks, with 10 visits at the study site and 5 visits conducted remotely by phone. During the study, researchers will assess participants at the start and after 36 weeks by measuring clinical events, changes in the six-minute walk test distance, and changes in heart failure symptoms using the Kansas City Cardiomyopathy Questionnaire. Safety and treatment effects will be closely monitored through these visits and assessments throughout the study period.

Researchers are investigating how the body processes the study medicine PF-07328948 in adults with and without different levels of liver impairment. The research aims to understand whether reduced liver function affects how this medicine is metabolized and processed, which may differ from healthy individuals. This is a Phase 1, open-label study focused on pharmacokinetics, safety, and tolerability of PF-07328948. Participants will take one oral tablet of PF-07328948 on the first day at the study clinic. After dosing, they will remain onsite for about six days for close monitoring. During this time, blood samples will be collected at multiple time points to measure levels of the study medicine and evaluate its behavior in the body. Throughout the study, the team will monitor participants' treatment experience, safety, and collect blood samples at various intervals on Day 1 to assess the drug's unbound fraction and concentration over time. This detailed evaluation helps determine how liver function impacts drug processing. The study includes adults aged 18 to 75 years with specific body weight and BMI criteria and involves safety monitoring during the entire stay at the clinic.