San Fernando

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating quabodepistat-containing treatment regimens for adults and adolescents aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis RRMDR-TB. The study aims to determine if adding quabodepistat to other TB drugs can shorten treatment duration to 4 months for fluoroquinolone-sensitive TB and provide a safer alternative compared to the current 6-month WHO-endorsed regimens. This Phase 3, randomized, open-label trial also compares treatments for patients with fluoroquinolone-resistant TB. Participants will be divided into two main groups based on fluoroquinolone sensitivity. Those with fluoroquinolone-sensitive RRMDR-TB will receive either an experimental 4-month regimen BPaQM bedaquiline, pretomanid, quabodepistat, moxifloxacin or a 6-month control regimen BPaLM bedaquiline, pretomanid, linezolid, moxifloxacin. Those with fluoroquinolone-resistant RRMDR-TB will receive either an experimental 6-month regimen BPaQ bedaquiline, pretomanid, quabodepistat or a control 6-month regimen BPaL bedaquiline, pretomanid, linezolid. Dosing schedules vary by regimen and last either 4 or 6 months. During the 16-month follow-up, participants will undergo regular assessments including sputum samples, chest X-rays, laboratory tests, and safety evaluations. Researchers will measure treatment effectiveness by the proportion with unfavorable outcomes 12 months after randomization and monitor adverse events. Additional outcomes include time to sputum culture conversion, microbiological relapse, and drug plasma levels. Safety will be closely monitored throughout treatment and follow-up periods.