Mueang Chiang Mai District

Researchers are evaluating the safety and effectiveness of enicepatide, a dual GLP-1/GIP receptor agonist, for managing weight in adults with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to understand its impact on weight loss in this population. Participants receive either enicepatide or a placebo once weekly through an integrated drug-device combination. The study uses a randomized, double-blind, placebo-controlled design to assess the effects of the treatment. The placebo is volume-matched and administered using the same method as the active drug. During the study, participants will have their body weight changes measured up to week 72 to assess efficacy. Researchers will monitor weight changes as the primary outcome. Participants must be able to self-administer the injections or receive them from a trained individual, and their safety and adherence will be observed throughout the study period.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are evaluating the safety and effects of fosmanogepix, a study medicine, for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida species. This Phase 3 clinical trial compares fosmanogepix to the standard treatment of caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard therapy by a margin of 15%. The study includes adult patients diagnosed with these infections. Participants will receive either fosmanogepix or caspofungin as an intravenous infusion daily at the study clinic. After the initial infusion phase, patients may switch to oral tablets of fosmanogepix or fluconazole capsules, which can be taken at the clinic or at home if discharged. Treatment duration varies by individual, lasting up to six weeks depending on infection clearance and symptom improvement. A follow-up visit will take place six weeks after stopping treatment. During the study, patients will undergo multiple visits to monitor their health and treatment response. Researchers will assess outcomes such as the proportion of patients alive at 30 days and the overall treatment success at the end of study treatment, up to day 42. Safety will be closely monitored throughout the study and during follow-up, ensuring comprehensive evaluation of the treatments over the entire participation period.

Researchers are evaluating the safety and effectiveness of fosmanogepix, given either intravenously or orally, for treating adults diagnosed with invasive mold infections. This Phase 3 study focuses on patients infected with molds such as Aspergillus species, Fusarium species, Lomentospora prolificans, Mucorales fungi, or other multidrug-resistant molds. The main goal is to compare the overall death rate at 42 days against a fixed threshold to assess treatment outcomes. Participants will be assigned to one of two groups: Cohort A includes patients receiving either the study drug fosmanogepix or the standard antifungal treatment based on institutional practice, while Cohort B includes patients receiving fosmanogepix as a salvage treatment after not responding to or not tolerating prior therapies. Fosmanogepix is administered through intravenous infusion or oral tablets. The study treatment period targets 84 days but can be extended up to 180 days depending on patient needs. Throughout the study, lasting up to approximately 8 months including follow-up, participants will undergo evaluations to monitor their response, safety, and overall health status. Researchers will track the all-cause mortality rate by Day 42 as the primary outcome. Safety and treatment effects will be assessed regularly during treatment and follow-up to ensure participant well-being and gather comprehensive data on fosmanogepix’s impact.

Researchers are evaluating the anti-tumor effects of golidocitinib compared to treatments chosen by doctors in adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). This phase 3, open-label, randomized, multinational study focuses on patients who have confirmed PTCL and whose disease has returned or not responded after at least one prior systemic treatment. The study includes specific subtypes of PTCL as defined by the World Health Organization classification. Participants will receive either golidocitinib at 150 mg orally once daily in 21-day cycles or one of several investigator's choice treatments, including chidamide, pralatrexate, gemcitabine, or belinostat, each given on different schedules and doses. Golidocitinib is taken daily with or without food, while the comparator drugs are administered orally or intravenously with specific timing within 21- or 28-day cycles. During the study, participants will be monitored for progression-free survival, which is the time from randomization until disease progression or death, assessed for up to approximately four years. Researchers will evaluate treatment effects through regular assessments, including clinical exams and safety monitoring. Patients must meet specific health criteria and agree to follow contraceptive guidelines throughout the trial.

Researchers are evaluating a new compound called AZD8205 as a potential treatment for advanced or metastatic solid tumors, either alone or combined with other anti-cancer drugs. This Phase I/IIa multi-center, open-label study focuses on patients with advanced solid tumors including breast cancer, biliary tract cancer, ovarian cancer, endometrial cancer, and squamous non-small cell lung cancer. The study aims to understand the safety and effects of AZD8205 and its combinations in these patient populations. Participants may receive AZD8205 alone or combined with other agents such as rilvegostomig, a bispecific antibody targeting TIGIT and PD-1; saruparib, a PARP inhibitor; or AZD9574, another PARP inhibitor. Various combinations include AZD8205 with rilvegostomig, saruparib, both saruparib and rilvegostomig, or AZD9574 with or without rilvegostomig. The study uses dose escalation and expansion phases to assess these treatments. Treatment is given according to the assigned group, with dosing schedules and combinations tailored to evaluate safety and tolerability. During the study, participants will be closely monitored for safety including adverse events, serious adverse events, and dose-limiting toxicities. Laboratory tests, ECGs, and vital signs will be regularly checked from the time of informed consent through 30 days after the last dose, covering about one year in total. Researchers will also assess measurable disease response and overall health status. This comprehensive evaluation helps determine the potential of AZD8205 and its combinations as treatments for advanced solid tumors.

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 effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.