Gaffney

Researchers are studying the safety and effects of combined doses of ensifentrine and glycopyrrolate in adults with chronic obstructive pulmonary disease (COPD). This Phase IIb trial compares two doses of the combination to each drug alone and to a placebo, aiming to evaluate their ability to improve lung function in adults aged 40 to 80 years with COPD symptoms and a history of smoking. Participants will be randomly assigned to one of six groups: two groups will receive fixed combinations of ensifentrine 3 mg with either 21.25 mcg or 42.5 mcg glycopyrrolate; two groups will receive glycopyrrolate alone at one of the two doses; one group will receive ensifentrine alone; and one group will receive a placebo. All treatments are inhaled twice daily using a standard jet nebulizer over a 28-day period. The study lasts about seven weeks, including 1 to 2 weeks for screening, 4 weeks of treatment, and a 1-week follow-up. Participants will undergo lung function tests measuring forced expiratory volume in one second (FEV1) at various time points and complete questionnaires about symptoms and quality of life. Researchers will monitor safety, lung function changes, symptom improvements, and adverse events throughout the study.

Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index (BMI), waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease (COPD) to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

This research aims to assess the long-term safety and explore the effects of astegolimab in adults with chronic obstructive pulmonary disease (COPD) who have completed a 52-week treatment period in earlier studies named GB43311 or GB44332. The study is an open-label extension phase III trial sponsored by Hoffmann-La Roche, focusing on participants aged 40 to 90 years. Participants who qualify from the parent studies will receive astegolimab through subcutaneous injections every two weeks throughout the study duration. This open-label extension allows all participants to receive the active drug without placebo comparison. During the study, researchers will monitor participants for any adverse events up to 12 weeks after the last dose, focusing on the safety of astegolimab. Participants will be regularly assessed to track any side effects and overall health changes related to their COPD condition while on this treatment. The study began in June 2023 and will continue until July 2034, allowing for long-term observation.

Researchers are studying patients with Type 2 Diabetes Mellitus (T2DM) to identify and describe their characteristics for possible involvement in current or future clinical trials focused on T2DM. The study aims to understand medication use patterns among these patients across different regions and better characterize their health status. Participants include adults with T2DM who are managed either through lifestyle changes alone or with stable doses of glucose-lowering medicines. The study involves a one-time visit during which participants will undergo assessments including blood collection (about 2 mL) and evaluation of their medical history, demographics, medication use, and blood sugar levels measured by HbA1c. During the single visit, researchers will collect information about medical and surgical history, current medications, and demographic data. They will measure HbA1c levels to assess blood sugar control and may refer participants to other ongoing or future T2DM studies. The study focuses on observation and data collection without active treatment, lasting only one day for each participant.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have a COPD diagnosis of at least one year, be receiving inhaled maintenance therapy, and have experienced at least two moderate or one severe COPD exacerbations in the past year. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand tezepelumab's impact on COPD symptoms and exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment phase will last for a minimum of 52 weeks and up to 76 weeks. After completing the treatment period, there will be a 12-week off-treatment safety follow-up to monitor participants' health. Throughout the study, participants will undergo regular assessments including lung function tests, questionnaires such as the St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and blood tests to measure eosinophil counts and drug levels. Researchers will track the annualized rate of moderate or severe COPD exacerbations as the primary outcome. Other evaluations include monitoring exacerbations requiring emergency visits or hospitalization, lung function changes, symptom scores, and immune responses. Participant safety and adherence to the study protocol will be closely monitored during and after treatment.

Researchers are studying the effects and safety of the medicine PF-07275315 for people aged 35 to 80 who have had moderate to severe chronic obstructive pulmonary disease (COPD) for at least one year. Participants must have a history of at least two moderate or severe COPD flare-ups in the past year and have been on stable maintenance treatments for at least six months. The study aims to compare PF-07275315 with a placebo to see if it is safe and how it affects COPD symptoms and flare-ups. Participants will receive multiple injections of PF-07275315 or a placebo in a clinic setting. The study has two parts: a Phase 2 part lasting 24 weeks and a Phase 3 part lasting 52 weeks. The Phase 2 participants will be involved for about 40 weeks with 11 clinic visits, while those in Phase 3 will participate for about 68 weeks with 18 visits. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the medicine or placebo. During the study, participants will undergo regular visits to monitor lung function using tests like forced expiratory volume in 1 second (FEV1), record flare-ups, and complete questionnaires about respiratory health. Researchers will also watch for side effects and changes in lab tests, heart activity, and vital signs. The primary measures include lung function changes at 24 weeks for Phase 2 and the rate of flare-ups over 52 weeks for Phase 3. Safety and health will be closely monitored throughout the study period.

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.