Hendersonville

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This trial evaluates the effectiveness of dotinurad compared with allopurinol in lowering serum uric acid levels in adults with gout-related hyperuricemia. The study focuses on reducing uric acid to below 6.0 mgdL after 24 weeks of treatment, addressing a common complication in gout patients. It is a phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years with a history of gout. Participants are randomly assigned to one of three groups one group continues allopurinol at their existing dose once daily through week 64 the second group receives dotinurad starting at 1 mg once daily for the first 4 weeks, then 2 mg once daily through week 64 the third group begins with 1 mg daily for 4 weeks, increases to 2 mg daily for 8 weeks, then continues 4 mg daily through week 64. All treatments are administered orally as over-encapsulated tablets. Throughout the study, participants undergo regular monitoring of serum uric acid levels and gout flares from baseline up to week 68. Assessments include measuring the percentage of participants achieving target uric acid levels at various points, gout flare rates, and treatment-emergent adverse events. The study also evaluates safety and tolerability over the course of the treatment period, which lasts up to approximately 68 weeks including follow-up.

Researchers are evaluating the efficacy of dotinurad compared with allopurinol in lowering serum uric acid sUA levels in adults with tophaceous gout. This Phase 3 trial focuses on adult participants aged 18 to 75 years who have measurable tophi and a diagnosis of gout for at least one year. The study aims to assess how well dotinurad reduces sUA levels at Week 24 compared to allopurinol, an established treatment for this condition. Participants are randomly assigned to one of two treatment groups. One group will stop their current allopurinol and continue with study-supplied allopurinol once daily through Week 76. The other group will discontinue allopurinol and start dotinurad at 1 mg daily for the first 4 weeks, then increase to 2 mg daily for the next 8 weeks, and finally 4 mg daily thereafter until Week 76. Both treatments are given as oral tablets, and participants are closely monitored throughout the study. During the study, participants will undergo various assessments including blood tests to measure serum uric acid levels at multiple time points, evaluation of tophi response, and tracking of gout flare frequency and severity. Safety monitoring will include recording any adverse events and serious side effects up to Week 80. The main outcome measures focus on the percentage of participants achieving target sUA levels at Week 24 and clinical responses in tophi at Week 76, with ongoing evaluations up to Week 80 to assess longer-term effects and safety.

Researchers are studying the safety and effects of two drugs, PF-08653945 and PF-08653944, given alone or together for weight loss in adults with overweight or obesity. This Phase 2b trial compares these drugs to a placebo to better understand their impact on body weight over time. The study is designed to evaluate different doses and combinations of these drugs to find the most effective approach. Participants receive subcutaneous injections of either PF-08653945 alone, PF-08653945 combined with PF-08653944, PF-08653944 alone, or a placebo. The study uses a randomized, double-blind design with multiple cohorts receiving different drug combinations or placebo. Treatments are administered as injections under the skin over a planned period of 48 weeks, with follow-up extending to 70 weeks to monitor safety and outcomes. During the study, participants will have their body weight measured at baseline and regularly through Week 48 and Week 60 to track changes. Researchers will assess the percentage of weight loss and monitor any treatment-emergent or serious adverse events up to Week 70. Participants will attend scheduled visits for injections and evaluations throughout the trial, which lasts for over a year in total.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are studying the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

Researchers are evaluating the safety and effects of a medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. The study focuses on adults aged 18 to 70 who have had asthma for at least 12 months and have been on regular maintenance treatments. Asthma is a condition that makes breathing difficult and can reduce quality of life and daily functioning. Participants will receive either PF-07275315 or a placebo through multiple injections under the skin during clinic visits over a 12-week period. The study is randomized and blinded, meaning neither participants nor researchers know who receives the medicine or placebo. The trial includes several experimental groups receiving different doses of PF-07275315 and a group receiving placebo to compare safety and effects. The study includes a 12-week treatment phase. During about 7.5 months of involvement, participants will attend nine clinic visits. Researchers will monitor lung function using tests like forced expiratory volume in 1 second FEV1, record any side effects or adverse events, and assess asthma control and quality of life through questionnaires. Safety will be followed for 24 weeks, including lab tests, vital signs, and heart monitoring. This helps understand how PF-07275315 affects lung function and overall health in asthma patients.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating a new medicine called PF-08634404 for adults with locally advanced or metastatic urothelial cancer, a type of bladder cancer that has spread to nearby tissues or other parts of the body. The study aims to assess the safety, effectiveness, how the medicine moves through the body, and its impact on cancer-related markers. This is a Phase 1B2 treatment study sponsored by Pfizer. Participants are divided into two groups Cohort A includes those who have already received treatment and will receive PF-08634404 alone, while Cohort B includes untreated participants who will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin. Both study medicines are given through an intravenous infusion. Treatment continues as long as it is beneficial and side effects are manageable. Before starting treatment, participants undergo a screening period to confirm eligibility. During the study, they have regular visits for treatment, health assessments, and tests to monitor cancer response, including scans. If the cancer worsens but treatment still helps and side effects are manageable, participants may continue treatment with approval. The study tracks outcomes such as tumor response, adverse events, survival, and drug levels over up to three years.

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma RCC, a type of kidney cancer that has spread locally or to other parts of the body. This study aims to understand how the medicine works alone or combined with other anticancer treatments, focusing on safety and cancer response. Participants must be adults with advanced RCC who have not yet received treatment for their advanced kidney cancer. Participants will receive PF-08634404 through intravenous infusions either alone or combined with other anticancer medicines such as ipilimumab or axitinib. The study includes different groups receiving these treatments sequentially, with all infusions delivered at clinical sites by medical staff. Treatment and evaluation will continue for up to approximately three years. During the trial, participants will have regular assessments including scans and lab tests to monitor cancer response and safety. Researchers will measure outcomes such as the confirmed objective response rate, adverse events, dose-limiting toxicities, and survival. Pharmacokinetics and immune responses to the study drug will also be tracked. Participants may be followed for up to three years to evaluate treatment effects and safety.