Zhu Ma Dian Shi

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

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 efficacy and safety of brenipatide combined with standard of care compared to placebo plus standard of care in delaying the worsening of symptoms in adults with bipolar disorder. This Phase 2, randomized, double-blind study aims to understand if brenipatide can help delay relapse in bipolar disorder patients. The study is sponsored by Eli Lilly and Company and focuses on adults aged 18 to 75 years diagnosed with bipolar disorder I or II. Participants will be randomly assigned to receive one of two doses of brenipatide or a placebo, each administered by subcutaneous injection alongside their standard of care medication. The trial is divided into three periods a screening period lasting about one month, a treatment period lasting at least six months, and a follow-up period lasting approximately two months. The total duration of participation may vary and can be shortened if symptoms worsen or if the participant withdraws. During the study, participants will self-inject the study medication, maintain study diaries, and complete questionnaires assessing their condition. Researchers will monitor time to relapse, changes in functional impairment, mood symptoms using specific rating scales, quality of life, patient global impressions, body weight, and pharmacokinetics. Safety will be closely observed, including the presence of treatment-emergent anti-drug antibodies. Participants are expected to attend regular visits throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of brenipatide alongside standard care compared to a placebo plus standard care in adult participants with major depressive disorder. This study aims to see if brenipatide can delay the return of major depressive symptoms. It is a Phase 3, randomized, double-blind trial sponsored by Eli Lilly and Company. Participants receive brenipatide or placebo through subcutaneous injections combined with their regular treatment. The study includes three periods a screening period lasting about 1 month, a treatment period of at least 12 months, and a follow-up period of about 2 months. The study duration may be shortened if depressive symptoms worsen or if participants withdraw. During the trial, participants will attend regular visits where various assessments will be conducted, including depression rating scales, functional impairment scores, and quality of life questionnaires. Researchers will monitor body weight changes, anxiety levels, and blood samples to measure drug levels and immune responses. The primary outcome is the time until relapse of major depressive disorder symptoms. Safety and adherence to self-injection and study procedures will be closely followed throughout participation.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

Researchers are evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

The trial investigates the use of MI078 capsules to treat postpartum depression in women aged 18 to 45 years. It is a multicenter, randomized, double-blind, placebo-controlled study aiming to assess the efficacy and safety of MI078 for this condition. Participants must have a diagnosis of major depressive disorder with onset during late pregnancy or early postpartum, and a certain level of depression severity as measured by the Hamilton Depression Rating Scale. Participants are randomly assigned to two groups one receiving MI078 capsules and the other receiving a matching placebo. The treatment is taken for 3 days during the treatment period. The study includes a screening phase lasting up to 14 days before treatment, a 4-day treatment period, and a follow-up period lasting until day 31 after treatment begins. During the study, participants will undergo clinical assessments including depression rating scales such as the HAM-D17 and other mood and anxiety scales. Researchers will monitor changes from baseline in depression scores and record safety information throughout the follow-up period. Participants are expected to comply with study requirements, lifestyle restrictions, and attend scheduled visits for evaluations over approximately one month.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.