Altona North

Researchers are evaluating the efficacy and safety of intravenously administered YN001 in adults diagnosed with coronary atherosclerosis who are also receiving background therapy for managing cardiovascular risk factors. This multinational, multicenter, phase 2b clinical trial is randomized, double-blind, and placebo-controlled to compare YN001 with placebo in this patient population. Participants will be randomly assigned to receive one of three doses of YN001 or matching placebo intravenously once weekly for 13 weeks. The doses include 40mg, 20mg, or 0mg placebo. The study consists of up to a 12-week screening and baseline period, a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up extending to approximately two years after randomization. During the study, participants will undergo various assessments including imaging to measure changes in coronary non-calcified plaque volume, carotid intima-media thickness, and plaque characteristics at multiple time points. Safety and immunogenicity will be monitored alongside pharmacokinetic analyses. The primary outcome focuses on relative change in coronary NCPV at week 13. Participants will be followed for up to 96 weeks to evaluate major adverse cardiac events and long-term safety.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

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 long-term effects of maridebart cafraglutide in adults with obesity or overweight. This extension study follows participants from a previous trial to assess the medications ongoing efficacy, safety, and tolerability over an extended period. The trial is designed as a phase 3 randomized and double-blind study to provide comprehensive information on treatment outcomes. Participants will receive different doses of maridebart cafraglutide administered by subcutaneous injection at varying intervals, including once every 4, 8, or 12 weeks. Some participants who received placebo or lower doses in the previous trial will undergo dose escalation or re-randomization to different dose groups or placebo. The study includes a dose-escalation phase for certain participants before initiating the assigned high dose. During the study, participants will be regularly monitored for changes in body weight compared to the original trial baseline, treatment-emergent adverse events, and serious adverse events. Additional assessments will track waist circumference, quality of life related to weight, and maintenance of weight loss. Participants are expected to complete visits and evaluations over approximately 48 weeks, with safety data collected up to 60 weeks from the start of the extension trial.

Researchers are evaluating the effectiveness of zabalafin hydrogel in people aged 2 years and older who have mild to moderate atopic dermatitis, also known as eczema. This Phase 2b randomized, double-blind study includes two groups one with mild to moderate atopic dermatitis and another with the same condition plus a secondary skin infection. The study aims to compare zabalafin hydrogel to a placebo vehicle to understand its impact on eczema symptoms using a validated global assessment scale. Participants will be randomly assigned in a 21 ratio to receive either zabalafin 9.5% hydrogel or a placebo gel. The study treatment lasts 16 weeks following up to 2 weeks of screening. During treatment, participants will visit the clinic every 2 weeks for the first month and then monthly until the end of the study. The study evaluates not only the effectiveness but also the safety and tolerability of zabalafin compared to the placebo. Throughout the study, participants will undergo assessments including the validated Investigators Global Assessment, Eczema Area and Severity Index, pruritus itching rating, and patient-reported eczema measures. Safety monitoring and evaluation of antibacterial effects in those with skin infections are included. Participants must comply with study procedures, avoid using other topical products on the eczema lesions, and attend scheduled visits over the approximately 16-week treatment period.

Researchers are evaluating the safety and effectiveness of ABP-745 in people experiencing an acute gout flare. This Phase 2, randomized, double-blind, international, multicenter study compares ABP-745 to standard colchicine treatment and placebo. The goal is to see how well ABP-745 reduces pain and swelling during a gout flare, with the main measure being the pain score after treatment. Participants will be randomly assigned to one of four groups two different doses of ABP-745 with a colchicine placebo, standard colchicine treatment with an ABP-745 placebo, or a placebo for both drugs. All treatments are given as tablets by mouth. The study will monitor participants from the first dose through up to 14 days to assess pain changes and any side effects. During the study, participants will have their pain measured using a visual analog scale at various times, including 24 hours and up to 8 days after the first dose. Researchers will also track any treatment-related adverse events for up to two weeks. Participants must maintain stable lifestyle habits and medication doses during the study. The total study duration and follow-up include safety assessments to understand the effects and tolerability of the treatments.

Researchers are evaluating the drug Efsubaglutide Alfa in adults aged 18 to 75 who are overweight or obese. This phase 2, multicenter, double-blind, randomized, placebo-controlled study aims to assess the drugs effectiveness, safety, how the body processes it, and immune response in people with a body mass index BMI between 27 and 30 with at least one related health condition or a BMI of 30 or above with or without other health issues. The study includes a 2-week screening period, a 22-week treatment phase, and a 4-week follow-up after treatment ends. Participants will receive Efsubaglutide Alfa or a placebo through weekly injections. The drug dose starts at 1 mg and is increased every two weeks through a series of steps until reaching a target dose that varies by study group, ranging from 20 mg to 80 mg. Some groups receive the highest dose every one or two weeks, and the total treatment lasts for 22 weeks. The study compares multiple dosing schedules to evaluate effects across different doses and frequencies. During the trial, participants will attend scheduled visits for weight and body measurements, blood pressure, and blood tests including blood sugar and cholesterol levels. Body composition will be measured using DEXA scans. Safety will be monitored throughout by tracking side effects and mental health using questionnaires. Blood samples will also be collected to measure drug levels and immune response. Overall, the study helps understand how the drug affects body weight and other health markers in people with overweight or obesity over about 28 weeks from screening to follow-up.