Wilmington

This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment. During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored. Patients will return for study visit every weeks (Visits 3-6) and will undergo safety assessments as per the protocol. At the end of this 4 week period, subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period. The study plans to enroll up to 6 cohorts of eligible patients sequentially, starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks. Subsequent cohorts will assess increasing tenapanor doses, following a dose escalation order. The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol.

This research aims to evaluate the effects of Palynziq (pegvaliase) treatment on pregnant women with maternal phenylketonuria (PKU) and their babies. It focuses on women who were exposed to pegvaliase at any time during pregnancy and breastfeeding. The study's goal is to understand maternal, fetal, and infant outcomes related to this exposure. The study includes women who were treated with pegvaliase within two weeks before their last menstrual period and continued through pregnancy and breastfeeding. Data will be collected retrospectively for at least three months before pregnancy, throughout the pregnancy, and during the infant's first year of life. The exposure to pegvaliase during each trimester and breastfeeding period will be recorded. Individual participation will last up to approximately 21 months. Participants will provide consent and allow researchers to gather medical information from their healthcare providers and their infant's providers. Data collected includes pregnancy outcomes and infant development over a 10-year period following pegvaliase exposure. The study will monitor maternal and infant health through medical records and follow-ups during pregnancy and the first year of life, ensuring thorough observation of treatment effects over time.

Researchers are investigating the long-term safety and effectiveness of APG777, a treatment for moderate-to-severe atopic dermatitis (AD), in patients who have already completed an initial APG777 study. This phase 2, multicenter, double-blind study focuses on those who may benefit from extended treatment with APG777 to better understand its ongoing effects and safety over time. The study includes three main periods: a screening visit that occurs at the end of the previous study's maintenance period, an extended treatment period where participants receive APG777 subcutaneous injections every 12 or 24 weeks, and a post-treatment follow-up period. Participants will continue using their chosen non-medicated moisturizer from the previous study throughout this extension. During the study, participants' health and response to treatment will be closely monitored, including tracking any treatment-emergent adverse events for up to three years. Researchers will assess the long-term safety and efficacy of APG777 while ensuring participants remain compliant with study protocols. This ongoing observation aims to provide detailed information on how APG777 affects patients over extended use.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are studying the effects of ensifentrine inhalation suspension compared to placebo in adults with non-cystic fibrosis bronchiectasis (NCFBE). The goal is to evaluate how ensifentrine affects the rate of lung flare-ups, symptoms, and quality of life in this condition. This Phase II trial is randomized, double-blind, and placebo-controlled to ensure unbiased assessment of ensifentrine's safety and effectiveness alongside standard care. Participants will be randomly assigned to receive either 3 mg of nebulized ensifentrine suspension or a placebo, both administered twice daily using a standard jet nebulizer. The treatment period will last at least 24 weeks and may continue up to 52 weeks, with neither the participants nor the study staff knowing which treatment is given. This setup helps compare ensifentrine's effects directly against placebo over an extended period. During the study, participants will attend regular visits for lung function tests, symptom assessments, and quality of life evaluations. Researchers will monitor lung flare-ups defined by the need for antibiotics or antivirals over approximately 52 weeks. Safety will be closely observed, and participants' ability to use the nebulizer and provide sputum samples will be assessed. This thorough monitoring aims to gather detailed data on ensifentrine's impact on NCFBE symptoms and flare-up frequency.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

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 effectiveness of NNC0487-0111 for people with excess body weight and knee osteoarthritis. This Phase 3 study compares NNC0487-0111 to a placebo, a treatment with no active medicine, to see if it helps reduce weight and knee pain. Participants have knee osteoarthritis diagnosed by specific clinical and radiographic criteria and experience ongoing knee pain. Participants receive weekly injections under the skin using a pre-filled pen injector. The injections, either NNC0487-0111 or placebo, are given in the thigh, abdomen, or upper arm. The study treatments include two dose levels of NNC0487-0111. Treatment assignment is randomized and blinded, meaning participants receive either the medicine or placebo by chance, not by choice. During the study, participants will be monitored for changes in body weight and knee pain using a standardized pain questionnaire over about 80 weeks. They will follow specific instructions about pain medication before assessments. Researchers will track treatment effects, safety, and any side effects throughout the study period.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Respiratory infections affecting the upper and lower airways are a significant public health concern causing illness and death globally. This trial is designed to assess the safety and potential effectiveness of INNA-051, an investigational nasal spray, in preventing or reducing the severity and duration of respiratory illnesses caused by viral infections. The study focuses on generally healthy adults aged 18 to 45 years who are at higher risk of exposure to these viruses due to factors such as their living or working environments. This is a Phase 2a, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants will receive either INNA-051 or a placebo nasal spray once a week. The trial has two parts: Part A involves weekly treatment for 4 weeks, focusing on safety and tolerability, while Part B involves treatment for 12 weeks to evaluate safety, tolerability, and efficacy in preventing symptoms of viral respiratory infections confirmed by laboratory tests. Both parts are conducted during the respiratory virus season, with participants self-administering the nasal sprays in an outpatient setting. Throughout the study, participants will be closely monitored with regular assessments including blood tests, symptom questionnaires, and recording of any adverse events. Safety measures include tracking treatment-emergent and serious adverse events, nasal irritation symptoms, and changes in various blood parameters. The study also measures the occurrence and severity of confirmed viral respiratory infections using laboratory confirmation and symptom scoring. Part A assessments last up to 8 weeks, while Part B assessments continue up to 16 weeks, capturing comprehensive safety and efficacy data during and after treatment.