Sui Ning Shi

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

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. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the effectiveness and safety of combining Dato-DXd with rilvegostomig as an additional treatment compared to standard care in adults with high-risk muscle invasive urothelial carcinoma MIUC who have undergone radical surgery. This Phase III trial focuses on participants with residual disease at high risk of recurrence after surgery. The study aims to see if the new combination improves disease-free survival compared to current standard treatments. Participants are randomly assigned to one of three groups Arm 1 receives Dato-DXd plus rilvegostomig intravenously every three weeks for up to one year Arm 2 receives Dato-DXd alone on the same schedule Arm 3 receives standard care, which includes nivolumab, durvalumab, or a combination of enfortumab vedotin and pembrolizumab, given intravenously at intervals ranging from every two to four weeks for up to a year. Treatment duration and dosing can be adjusted based on tolerance and investigator assessment. During the trial, participants will have visits approximately every three weeks or as per standard care schedules, depending on their assigned group, for up to 12 months of treatment. Researchers will monitor disease recurrence and survival outcomes for up to 78 months from the first participants enrollment. Assessments include clinical evaluations and disease status monitoring to measure disease-free survival and overall survival. Participants will be followed closely to assess safety and effectiveness of the treatments over this extended period.

This research aims to evaluate the potential for patients with severe asthma treated with Tezepelumab to safely reduce their background maintenance asthma medications while keeping their asthma symptoms under control. It is a Phase 3b, single-arm, multi-center study conducted in China involving about 400 patients aged 12 to 80 years who have severe asthma and are on medium to high doses of ICSLABA therapy with or without additional controllers. The study focuses on Chinese patients maintaining asthma control after starting Tezepelumab treatment. Participants will receive Tezepelumab treatment while maintaining their current asthma medications initially. The study will observe the potential to step down or reduce these background therapies over time. The treatment period lasts up to 52 weeks, during which researchers will monitor how well patients maintain asthma control while reducing their standard controller regimen. This single-arm study does not include a comparator group. Participants will be involved for up to 52 weeks, during which their lung function, asthma symptom control, exacerbation rates, and quality of life will be assessed regularly. Various questionnaires, pulmonary function tests, symptom diaries, and biomarker evaluations will be conducted from the start of treatment through week 52. Safety and efficacy measures will be monitored throughout the study to assess the impact of reducing background asthma medications while on Tezepelumab.