Valinhos

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 medicine BI 3000202 for adults with systemic lupus erythematosus SLE, a condition involving immune system problems. The study is a phase 2 trial that tests different doses of BI 3000202 to find the best dose for people with moderate to severe SLE. Participants are randomly assigned to one of five groups, including four groups receiving different doses of the medicine and one group receiving a placebo, which looks like the medicine but has no active drug. Participants take their assigned tablets daily for one year while continuing their usual SLE treatments. The study groups include four different dose levels of BI 3000202 and a placebo group. During the study, participants regularly visit the study site for check-ups and monitoring. This careful schedule helps researchers watch for any effects or side effects of the treatment. Throughout the study, doctors assess participants health, monitor any unwanted effects, and compare outcomes between groups. The main measurement is whether participants achieve a response on the Systemic Lupus Erythematosus Responder Index SRI-4 at week 32. Additional measurements include responses at week 52 and disease activity scores. Participants stay involved for a bit longer than one year, with regular visits to the study site for health checks and to ensure their well-being.

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

This research aims to evaluate the effectiveness and safety of products based on Tribulus terrestris, L. in men diagnosed with oligospermia, a condition characterized by low sperm count. The study focuses on men between 25 and 60 years old who have a sexual partner and an indication for drug treatment involving steroid hormones or related compounds. The trial is a phase 4, randomized, double-blind study comparing different doses of Tribulus terrestris with a placebo. Participants will be randomly assigned to receive one of several study groups Tribulus terrestris at doses of 94 mg, 250 mg, or 280 mg, or a placebo. The treatment period lasts for 3 months, during which participants will take the assigned product as directed. The study is designed to carefully manage any risks while assessing how the products affect sperm quality compared to placebo. During the study, men will undergo evaluations of their spermogram to measure changes in sperm characteristics. Researchers will monitor safety through clinical assessments and laboratory tests, including liver enzyme and creatinine levels. The primary outcome is the effectiveness of each product in improving sperm parameters over the 3-month period. Participants health and well-being will be closely followed throughout the study.

This trial investigates how well a fixed-dose combination of dipyrone monohydrate, caffeine, and chlorpheniramine maleate works to improve symptoms of the common cold and flu in adults aged 18 to 60 years. The study evaluates the safety and effectiveness of this combination compared to an active comparator and a placebo in adults experiencing nasal obstruction and congestion. It aims to provide insight into symptom relief within a few days of treatment. Participants are randomly assigned to one of three groups one receiving 1000 mg dipyrone monohydrate with 60 mg caffeine and 4 mg chlorpheniramine maleate, another receiving a lower dose of these drugs, or a placebo group. The study is double-blind, so neither participants nor researchers know which treatment is given. The treatments are administered as fixed-dose tablets, and the trial is designed to compare the different doses impact on symptom improvement. During the study, participants attend visits where researchers monitor symptoms of nasal obstruction and congestion over three days. They assess how many participants show improvement and record any safety concerns. Participants must comply with study procedures, including not having used other symptomatic treatments and following visit schedules. The total participation period lasts until the primary outcome is assessed at three days after treatment begins, with safety and symptom monitoring throughout.