Norwood

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the effects of KAI-9531, a weekly subcutaneous injection, on body weight changes in adults living with obesity or overweight who also have weight-related health conditions but do not have diabetes. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare KAI-9531 against a placebo to understand its impact on weight reduction over time. Participants will receive either KAI-9531 or a placebo as a subcutaneous injection once a week. The study focuses on the percent change in body weight from the start of treatment to week 76. Both the treatment and placebo groups will be monitored throughout the trial to assess efficacy and safety. During the study, participants will have their body weight measured at baseline and week 76 to track changes. Researchers will also monitor safety and other health factors throughout the trial. The total participation duration includes the treatment period up to week 76, with assessments to evaluate the impact of the injections on weight and related health conditions.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are evaluating the effects of Efsubaglutide Alfa, an investigational drug, in adults who are overweight or obese. This phase II trial aims to assess its safety, effectiveness, how the body processes the drug, and immune responses. Participants include those with a body mass index (BMI) between 27 and 30 kg/m2 with at least one related health condition, or those with a BMI of 30 kg/m2 or higher regardless of other conditions. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial to provide reliable results. Participants will receive different doses and schedules of Efsubaglutide Alfa or a placebo during a 22-week treatment period. The doses include 20 mg weekly, 40 mg weekly or every two weeks, and 80 mg weekly or every four weeks. The study starts with a 2-week screening period to determine eligibility, followed by the 22-week double-blind treatment phase where neither participants nor researchers know who receives the drug or placebo. After treatment, there is a 4-week follow-up period without medication to monitor participants. Throughout the study, participants will have regular visits and assessments to monitor changes in body weight from the start of treatment. Researchers will also evaluate safety and drug effects through physical exams, laboratory tests, and tracking of any side effects. The total study time for participants is approximately 28 weeks, including screening, treatment, and follow-up. The main goal is to measure the percentage change in body weight after 22 weeks of treatment with Efsubaglutide Alfa.

Researchers are evaluating the safety and immune response of a new pneumococcal vaccine called PnMAPS30plus in healthy adults aged 50 to 64 years. This phase 1 trial compares the investigational vaccine to an approved pneumococcal vaccine (PCV20) to see if it is safe, well-tolerated, and stimulates antibody production that protects against pneumococcal disease. Participants will receive a single dose of either PnMAPS30plus or PCV20 by intramuscular injection. After vaccination, participants will be monitored for about six months. The study includes careful observation of side effects and immune responses after receiving the vaccine. During the study, participants will complete electronic diaries and attend follow-up visits for clinical exams and assessments. Researchers will track administration site reactions, systemic side effects, serious adverse events, special interest adverse events, lab abnormalities, and any withdrawals due to side effects. The total study duration for each participant is approximately six months, allowing comprehensive safety and immune response evaluation.

Researchers are evaluating whether Ultra Low Frequency (ULF) neuromodulation can help treat adults with chronic, difficult-to-treat nociceptive low back pain. This study also aims to determine the safety of ULF therapy compared to conventional medical treatments over a 24-month period. Participants have persistent back pain that has not responded well to other treatments, and the trial will explore if ULF therapy reduces pain and if any unexpected medical issues arise during treatment. Participants are randomly assigned in a 2:1 ratio to receive either ULF therapy combined with conventional medical management or conventional medical management alone. Those assigned to ULF therapy will undergo a temporary trial phase and may receive a permanent device implant if they experience at least 50% pain relief. At six months, participants who meet certain criteria can switch to the other treatment group. The primary goal is to assess back pain improvement after three months, with ongoing follow-up for two years. During the study, participants will attend regular clinic visits for checkups and data collection. Researchers will monitor pain levels using standard measures, including the back pain visual analog scale (VAS) responder rate at three months. Safety and effectiveness will be tracked throughout the 24-month study period, and participants will complete questionnaires and other assessments to evaluate their progress and treatment impact.