Palm Springs

Researchers are evaluating the potential of GB-0895, an investigational drug, as an additional treatment for adolescents and adults with severe asthma that is not well controlled by inhaled corticosteroids and other common asthma medications. This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of GB-0895 over one year, with an optional extension phase. The study includes participants aged 12 to 80 years with documented severe uncontrolled asthma despite current therapy. Participants will be randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every six months during the 52-week treatment period. The study also includes phases for screening and run-in before treatment, followed by a follow-up period lasting up to 38 weeks after treatment ends. An optional open-label extension allows participants to continue receiving GB-0895 at specified weeks after the initial treatment phase. During the study, participants will attend visits every 1 to 2 months after the first month to monitor health and treatment effects. Assessments include lung function tests, asthma symptom questionnaires, quality of life evaluations, and tracking of asthma exacerbations. Researchers will closely monitor safety and treatment responses through these evaluations and collect data on various health measures to understand the drugs impact on severe asthma over the course of the study.

This research aims to evaluate the effectiveness and safety of North Star desiccated porcine thyroid extract tablets in adults with primary hypothyroidism, including Hashimotos Thyroiditis. The trial is a Phase 3, open-label, single-arm study conducted across multiple centers, focusing on treatment outcomes for this condition. Participants will receive North Star desiccated porcine thyroid extract tablets as the study treatment. The study monitors thyroid-stimulating hormone TSH levels to assess whether they remain within the normal range at 24 weeks and at prior post-baseline visits without abnormal readings. Safety evaluations include tracking adverse events, serious adverse events, laboratory tests, ECGs, and physical exams through 30 weeks. During the study, participants will be closely monitored with regular assessments of thyroid function and safety measures. Researchers will collect clinical data, lab results, and examine physical health to understand treatment impact. The total follow-up period extends to at least 30 weeks, allowing detailed observation of treatment effects and potential side effects in adults aged 18 to 75 years with stable hypothyroidism management.

Researchers are evaluating the effectiveness of oral KAI-7535 taken once daily compared to a placebo in adults living with obesity or overweight who have at least one weight-related health condition, excluding those with diabetes mellitus. The study also examines how well KAI-7535 works in participants with type 2 diabetes mellitus. Safety, tolerability, and other weight-related results will be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a placebo once a day. The study includes multiple dosing schedules of KAI-7535 to evaluate its effects. The trial follows a parallel design with a quadruple masking method to ensure unbiased results. The treatment period lasts up to 44 weeks. Throughout the study, participants will have their body weight and body mass index measured at the start and at week 44. Researchers will track the percentage change in body weight and the number of participants achieving weight loss of 5% or 10%. Safety and tolerability will also be monitored. The entire participation period can last over 44 weeks, including screening and follow-up assessments.

Researchers are evaluating the effectiveness and safety of fusidic acid 1% eye drops compared to a placebo for treating bacterial conjunctivitis in both adults and children. This Phase 3 clinical trial aims to show that fusidic acid 1% is superior to placebo in curing bacterial conjunctivitis and to further confirm its safety when applied topically to the eyes. Participants will be randomly assigned to one of two groups one group will apply one drop of fusidic acid 1% in each eye twice daily for seven days, and the other group will use a placebo eye drop with the same schedule. The doses are ideally spaced about 12 hours apart, but the twice-daily application schedule is prioritized over exact timing. During the study, participants will be assessed for clinical cure and microbial eradication at Day 4 and Day 8 visits. Researchers will monitor safety and treatment effects through these evaluations and by tracking any adverse events. The total participation duration covers at least the seven days of treatment plus follow-up assessments, helping establish both effectiveness and safety profiles for the treatment.

This research aims to evaluate the efficacy, safety, and tolerability of Suzetrigine in adults experiencing pain related to diabetic peripheral neuropathy DPN. The study focuses on participants with type 1 or type 2 diabetes who have had bilateral lower extremity pain from DPN for at least one year, seeking to understand how Suzetrigine impacts their pain levels compared to placebo. Participants will be randomly assigned to one of two groups those receiving Suzetrigine tablets and those receiving a matching placebo, both taken orally. The study uses a parallel design and is conducted in a double-blind manner to assess the treatment effects over a 12-week period. During the study, participants will have their daily pain intensity measured using the Numeric Pain Rating Scale NPRS and physical health status assessed via the SF-36 questionnaire. Researchers will monitor changes from baseline to week 12 to evaluate the treatment impact. The study spans from screening through 12 weeks of treatment, with safety and tolerability closely observed throughout this period.

This research aims to evaluate the long-term safety and tolerability of pelacarsen TQJ230 administered once a month at 80 mg in patients who have elevated lipoproteina and established atherosclerotic cardiovascular disease ASCVD. The study is an open-label, rollover extension designed for participants who have successfully completed prior double-blind parent studies involving pelacarsen. Participants will receive open-label pelacarsen 80 mg by subcutaneous injection once every month during this extension program. This phase 3 study continues treatment from the parent trial and provides post-trial access to pelacarsen for eligible participants who completed their assigned treatments previously. During the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will also assess changes in lipoproteina levels compared to baselines from both the parent and extension studies at multiple time points, including baseline, 3, 12, 24, 36, and 48 months. Participants are expected to attend scheduled visits for safety evaluations and lab tests throughout the study duration.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.