East Greenwich

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are studying the immune response and safety of mRNA-1018-H5, a pandemic influenza vaccine, in adults aged 18 years and older. The trial aims to assess how well two doses of this vaccine trigger antibody production and to monitor any side effects or reactions. This is a Phase 3, randomized, observer-blind, placebo-controlled study focused on the influenza virus. Participants will receive either the mRNA-1018-H5 vaccine or a placebo, both provided as sterile liquid injections. The study involves two doses and includes detailed monitoring for immune response and side effects after vaccination. The trial compares the vaccine to a placebo to evaluate its immunogenicity and safety. During the study, individuals will undergo medical evaluations including physical exams and pregnancy testing if applicable. Researchers will measure antibody levels at Day 43 and record any local or systemic reactions up to Day 29 after injections, as well as any adverse events up to Day 205. The study tracks serious and medically-attended adverse events to ensure careful safety monitoring throughout the participation period.

Researchers are evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are evaluating the safety and effectiveness of a drug called MEDI0618 compared to a placebo in adults with episodic migraine. This Phase 2 study includes participants aged 18 to 70 years who have a history of migraine headaches, including those who have tried and failed at least two small molecule migraine preventive treatments. The study also enrolls participants who have either not yet received or have failed treatment with anti-calcitonin gene-related peptide (aCGRP) therapies. Participants receive subcutaneous injections of MEDI0618 or a placebo in a randomized, double-blind design. The study is conducted across multiple centers, with parallel treatment groups. It focuses on reducing the number of migraine headache days by comparing the effects of repeat doses of MEDI0618 to placebo over the treatment period. During the study, participants will track their migraine headache days and other relevant symptoms. Researchers will assess the efficacy of MEDI0618 in preventing migraine headaches between weeks 9 and 12. Safety, tolerability, and other health measures will be monitored throughout the study to ensure participant well-being. The total participation period includes baseline data collection followed by the treatment and evaluation phases.

Researchers are evaluating the safety, tolerability, and immune response of a fifth dose of the 6-valent OspA-based Lyme disease vaccine called VLA15 in healthy individuals aged 7 years and older. This Phase 3, randomized, placebo-controlled, double-blinded study aims to understand the effects of an additional vaccine dose on protection against Lyme disease and to monitor for any adverse reactions or new medical conditions. Participants will be randomly assigned in a 5:1 ratio to receive either one dose of VLA15 or a saline placebo injection in the upper arm during the first clinic visit. The study involves about 1712 participants who have previously received four doses of VLA15 and had blood samples taken after the fourth dose. The total study duration is approximately 12 months, during which participants will attend four scheduled clinic visits. Throughout the study, participants will undergo health checks and provide small blood samples. Researchers will monitor for local and systemic reactions within 7 days after vaccination, adverse events up to one month post-vaccination, and any serious adverse events or newly diagnosed chronic medical conditions through the entire study period. Immune responses to the vaccine will be measured one month after the fifth dose. Safety will be overseen by an independent data monitoring committee.

This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are studying the effectiveness and safety of KAI-9531, a drug given as a once-weekly subcutaneous injection, in adults living with obesity who do not have diabetes. The study aims to show that KAI-9531 leads to greater weight loss compared to semaglutide, another injection given weekly, and a placebo. This is a Phase 3 randomized, partially-blinded trial that compares these treatments in people with a body mass index (BMI) of 35 kg/m² or higher who have tried and failed to lose weight through diet and exercise within the last six months. Participants will be assigned to receive either KAI-9531, semaglutide, or a placebo, all administered by subcutaneous injection once a week. The study will monitor changes in body weight over a period of 76 weeks to assess which treatment is more effective. The trial design includes active and placebo-controlled groups to carefully evaluate the impact of KAI-9531 on weight management. During the study, participants will undergo assessments to measure their body weight and other health parameters at baseline and throughout the 76-week period. The main outcome being measured is the percent change in body weight from the start of the study to week 76. Safety and tolerability of the treatments will also be monitored. Participants will be followed closely to ensure adherence and to track any side effects or changes in health status throughout the study duration.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine in adults with pain caused by diabetic peripheral neuropathy (DPN). This phase 3 study focuses on participants who have had diabetes type 1 or type 2 with bilateral lower limb pain for at least one year and aims to compare Suzetrigine's effects against a placebo. Participants will receive either Suzetrigine tablets or a placebo that looks like Suzetrigine, taken orally. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives which treatment. The main goal is to measure the change in weekly average daily pain intensity using the Numeric Pain Rating Scale (NPRS) over 12 weeks. During the study, participants will track their daily pain levels to assess treatment effects. Researchers will monitor safety and tolerability throughout the 12-week period, focusing on changes in pain intensity compared to the baseline. Participants must weigh at least 45 kilograms and have a body mass index between 18 and 40 kg/m². The study allows adults aged 18 to 80 years with controlled diabetes and specific pain levels to join.

Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine tablets in adults with pain caused by diabetic peripheral neuropathy (DPN). This phase 3 study compares Suzetrigine to a placebo and to Pregabalin capsules, both taken orally. Participants have type 1 or type 2 diabetes with nerve pain in their lower legs and meet specific pain severity levels. Participants receive either Suzetrigine tablets or a matching placebo, and some receive Pregabalin capsules or a matching placebo. The study is randomized and double-blind, meaning neither participants nor researchers know who receives which treatment during the trial. Treatments are taken orally over a 12-week period to assess their impact on pain. During the study, participants track their daily pain intensity using a numeric pain rating scale. Researchers measure the change in average weekly pain score from baseline to week 12. Safety, tolerability, and any side effects are monitored throughout. Participants must meet weight and body mass index criteria and have stable pain levels before starting. The total participation time includes a baseline period and 12 weeks of treatment.