Waitara

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 2b study to evaluate the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). The study aims to find the best dose of GIA632 for further testing in a Phase 3 program. Participants must have a confirmed diagnosis of NSV with specific body surface area and Facial Vitiligo Area Scoring Index (F-VASI) scores. Participants will receive either GIA632 or a placebo during a 48-week core treatment period. This period is designed to establish the dose-response relationship and compare the effects of GIA632 with placebo. After this, there will be an extension phase to assess the longer-term safety and efficacy of the treatment. During the study, participants will be monitored for changes in their facial vitiligo through F-VASI scores from baseline to week 24. Researchers will also observe overall safety and treatment effects throughout the 48 weeks and the extension period. Participants will complete study-related questionnaires and follow study procedures to support the research assessments.

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 studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating BGB-45035 in a first-in-human study to understand its safety, tolerability, pharmacokinetics, and pharmacodynamics. The study includes healthy adults and adults with autoimmune skin diseases such as atopic dermatitis and prurigo nodularis. The study is a Phase 1 trial lasting up to 24 months and also includes a biomarker evaluation cohort. BGB-45035 and placebo are given orally as single or multiple doses at various levels. The study has several parts: Parts A-D involve up to 14 days of treatment in healthy participants; Part E involves up to 12 weeks of treatment in adults with autoimmune skin conditions; Part F includes up to 3 weeks of treatment for biomarker assessment. A safety follow-up occurs 30 days after the last dose. Participants will undergo clinical laboratory tests, vital sign checks, cardiac monitoring, and safety assessments from the first dose through follow-up. Researchers will track adverse events and monitor changes in lab values and heart function. The study measures safety and tolerability over varying durations depending on the study part, with close observation during and after treatment.

Researchers are evaluating the safety and effectiveness of a drug called HB-1 compared to placebo and two other medications in adults aged 18 to 65 years diagnosed with Panic Disorder. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to include approximately 240 to 600 participants, including those with or without certain co-existing conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to receive HB-1, telmisartan, verapamil, or a matched placebo, all provided as tablets. The treatment period lasts 12 weeks, after which a safety follow-up visit will occur one week after the last dose. Throughout the study, patients and researchers will not know which treatment the participants receive to ensure unbiased results. During the trial, participants will be monitored regularly for the number of unexpected panic attacks and any side effects that may arise, with assessments occurring weekly during treatment and at follow-up. Safety evaluations, including laboratory tests and questionnaires, will be conducted at specific intervals to track participants' health and treatment effects throughout the study duration.

Researchers are evaluating the safety and effectiveness of a topical gel called zabalafin for treating people with mild to moderate atopic dermatitis, also known as eczema. This Phase 2b study includes two groups: one with mild to moderate atopic dermatitis and another group with mild to moderate atopic dermatitis plus a secondary skin infection. The goal is to compare zabalafin hydrogel against a placebo (vehicle) over a 16-week treatment period. Participants will be randomly assigned to receive either zabalafin hydrogel or a placebo in a 2:1 ratio. The study includes up to 72 participants across 10 sites in Australia. After up to 2 weeks of screening, participants will apply the assigned gel and visit the study site every 2 weeks for the first month, then monthly until the 16-week treatment ends. This double-blind study means neither participants nor researchers know who receives which treatment. During the study, participants will undergo regular evaluations including a clinical assessment using the validated Investigator's Global Assessment scale (vIGA) to measure treatment effects. Researchers will monitor the severity of eczema, skin lesion size, itching intensity, and any side effects. Participants must follow study procedures, including avoiding other topical products on affected skin areas and attending scheduled visits for up to 113 days.

Researchers are conducting a Phase 1/2 randomized, observer-blinded, dose-escalation trial to evaluate the safety, tolerability, and immune response of an investigational herpes zoster vaccine called Z-1018 compared to the approved Shingrix vaccine. The study involves healthy adults aged 50 years and older, aiming to better understand how these vaccines perform in preventing shingles and related complications. In Part 1 of the trial, about 440 participants aged 50 to 69 years will be randomly assigned to one of ten groups receiving different doses of Z-1018 or to the Shingrix group. Part 2 will enroll approximately 324 participants aged 70 years or older to receive either the selected Z-1018 dose from Part 1 or Shingrix in a 1:1 ratio. Participants receive two vaccine doses, and Part 2 includes extended follow-up for four years after the initial 12-month post-vaccination period to assess long-term immune protection and incidence of shingles and postherpetic neuralgia. Participants will be monitored for local and systemic reactions up to seven days after each dose and adverse events for 28 days post-injection. Serious and medically attended adverse events will be tracked for up to 12 months after the last dose. Immune responses will be measured four weeks after the second dose by vaccine response and antibody levels. Study visits include medical evaluations, laboratory tests, and adherence assessments throughout the trial duration.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.