Lomita

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating the effect and safety of different doses of a new medicine called NNC0662-0419 in people living with type 2 diabetes. This study compares NNC0662-0419 to a placebo or to semaglutide, an approved medication for type 2 diabetes. The goal is to determine if NNC0662-0419 is effective and safe for treating this condition in a phase 2 dose-finding study. Participants will receive one of the three treatments: NNC0662-0419, semaglutide, or placebo, all given by weekly subcutaneous injections. The treatment assignment is randomized, meaning participants are assigned to their group by chance. The study tests different doses of NNC0662-0419 to find the best dose for treating type 2 diabetes. During the study, researchers will monitor changes in participants' blood sugar levels by measuring glycated haemoglobin (HbA1c) at weeks 16, 28, and 40 compared to the start of the study. Participants will be regularly assessed for safety and treatment effects. The study includes adults aged 18 to 75 years and tracks the impact of the treatments over several months.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults who have excess body weight and type 2 diabetes. This Phase 3 clinical trial compares NNC0487-0111 with a placebo to see how well it helps participants lose weight. The study focuses on adults diagnosed with type 2 diabetes at least 180 days before screening, who have a specific range of blood sugar levels (HbA1c between 7-10%). Participants receive treatments as weekly injections under the skin using a pre-filled pen injector (PDS290) applied to the thigh, abdomen, or upper arm. They are randomly assigned to receive either NNC0487-0111 or a placebo that looks like the active treatment but contains no medicine. The study treatments are given once a week throughout the trial. During the study, participants are monitored for changes in their body weight from the start of the trial up to week 84. Researchers also assess safety and other health measures. Participants continue their usual treatment with lifestyle changes or certain oral diabetes medications that have been stable before joining. The trial follows them closely to evaluate how the treatment affects their weight and diabetes control over time.

Researchers are evaluating the effects of KAI-9531, given by weekly subcutaneous injection, compared to a placebo in adults living with obesity who do not have diabetes. This Phase 2b study aims to determine how KAI-9531 impacts body weight over time, specifically measuring the percent change from baseline to week 48. Participants will receive either KAI-9531 or a placebo via subcutaneous injection once a week during the study. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the treatment and placebo groups. The main treatment period lasts 48 weeks. During the study, participants will have their body weight measured at baseline and at week 48 to assess changes. Researchers will monitor safety and efficacy throughout the treatment period. The total participation time includes the treatment period and any necessary follow-up visits to track outcomes and ensure participant well-being.

Researchers are investigating the effectiveness and tolerability of two different dosing schedules of budesonide orodispersible tablets for adults with active eosinophilic esophagitis, a condition characterized by inflammation of the esophagus. This Phase III trial aims to demonstrate that taking 1 mg twice daily is not inferior to taking 2 mg once daily in inducing clinical and pathological remission over six weeks. Participants will be randomly assigned to receive either 1 mg budesonide tablets twice daily or 2 mg once daily, with tablets taken 30 minutes after a meal. The treatment period lasts six weeks, during which the effect of the medication on inducing remission will be evaluated. Throughout the study, participants will be monitored for remission through clinical assessments and histological evaluations after six weeks of treatment. Safety and tolerability will also be assessed to understand the impact of the medication schedule. The total study duration includes this six-week treatment phase, focusing on inducing remission and observing patient response.